Open the publication - UEF Electronic Publications - Itä

Eeva-Eerika Helminen
Knee Osteoarthritis: Determinants of
Pain and Function and Effects of a
Group-Based Cognitive-Behavioural
Intervention
Publications of the University of Eastern Finland
Dissertations in Health Sciences
EEVA-EERIKA HELMINEN
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Grano!Oy!
Kuopio,!2015!
!
Series!Editors:!!
!
Professor!VeliSMatti!Kosma,!M.D.,!Ph.D.!
Institute!of!Clinical!Medicine,!Pathology!
Faculty!of!Health!Sciences!
!
Professor!Hannele!Turunen,!Ph.D.!
Department!of!Nursing!Science!
Faculty!of!Health!Sciences!
!
Professor!Olli!Gröhn,!Ph.D.!
A.I.!Virtanen!Institute!for!Molecular!Sciences!
Faculty!of!Health!Sciences!
!
Professor!Kai!Kaarniranta,!M.D.,!Ph.D.!
Institute!of!Clinical!Medicine,!Ophthalmology!
Faculty!of!Health!Sciences!!
!
Lecturer!VeliSPekka!Ranta,!Ph.D.!(Pharmacy)!
School!of!Pharmacy!
Faculty!of!Health!Sciences!
!
Distributor:!!
University!of!Eastern!Finland!
Kuopio!Campus!Library!
P.O.Box!1627!
FIS70211!Kuopio,!Finland!
http://www.uef.fi/kirjasto!
!
ISBN!(print):! 978-952-61-1846-8
ISBN!(pdf):! 978-952-61-1847-5
ISSN!(print):
! 1798-5706
ISSN!(pdf):
!
1798-5714
ISSNSL: 1798-5706
Author’s address: Supervisors: Reviewers: III Psychiatry Department of Social Services and Health Care City of Helsinki HELSINKI FINLAND Docent Jari Arokoski, M.D., Ph.D. Department of Physical and Rehabilitation Medicine Kuopio University Hospital Institute of Clinical Medicine Faculty of Health Sciences University of Eastern Finland KUOPIO FINLAND Docent Sanna Sinikallio, Health Psychologist, Ph.D. School of Educational Sciences and Psychology Philosophical Faculty University of Eastern Finland JOENSUU FINLAND Professor Heikki Hurri, M.D., Ph.D. Rehabilitation Unit ORTON HELSINKI FINLAND Professor Kristiina Härkäpää, Health Psychologist, Ph.D. Rehabilitation Science Faculty of Social Sciences University of Lapland ROVANIEMI FINLAND Opponent: Docent Timo Pohjolainen, M.D., Ph.D. Helsinki Hospital Spine Center HELSINKI FINLAND IV!
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XI Acknowledgements This study was carried out at the Department of Physical and Rehabilitation Medicine, Kuopio University Hospital, in 2010–2015. The idea for this project arose at the public examination for the dissertation of Tuomas Liikavainio, M.D., Ph.D., in June 2010. There was discussion on how psychological factors contribute to pain and disability in knee osteoarthritis patients, and his opponent Docent Timo Pohjalainen, M.D., Ph.D, remarked that despite these findings, there have only been relatively few randomized controlled trials with psychological interventions. I am deeply grateful to my supervisory team, Docent Jari Arokoski, M.D., Ph.D., and Docent Sanna Sinikallio, Ph.D. for all the time and effort they have put into this project. Their work as supervisors really complemented each other in terms of knowhow and style of instructing. The vast experience of Docent Jari Arokoski in the field of osteoarthritis research and his uncompromising commitment to this study, as well as to supervising this dissertation provided a solid basis for the whole project. Especially in times of difficulties and doubt, his support kept me going. Docent Sanna Sinikallio’s profound insight into pain psychology among musculoskeletal pain patients, both in theory and in practice, was invaluable. I greatly value her forward-­‐‑looking way of coaching me through the dissertation work. I wish to express my gratitude to the other members of our research group, Anna Valjakka, Lic.A.Psych., for her insightful commentary on the project and the translation of the intervention manual, and Rauni Väisänen-­‐‑Rouvali, M.Sc., for her contribution to the intervention program in practice. A warm thank you to Professor Olli-­‐‑Pekka Ryynänen, M.D., Ph.D., for his help with patient randomization, as well as questions concerning cost-­‐‑
effectiveness. A special word of appreciation goes to Olavi Airaksinen, M.D., Ph.D., for taking the study project under the wing of the Department of Physical and Rehabilitation Medicine at Kuopio University Hospital. My warmest appreciation goes to the official reviewers of the study, Docent Heikki Hurri, M.D., Ph.D., and Professor Kristiina Härkäpää, Ph.D., for their constructive criticism and suggestions that considerably improved this dissertation. I am extremely thankful to Tuomas Selander, M.Sc., for the patience, support and guidance in statistical matters of this project. A warm thank you to Pauli Kuosmanen, M.D., from Kuopio Health Centre for his essential help during the recruitment process. I also want to thank Roy Siddall for revising the language of this thesis and the original publications. I am deeply grateful to Professor Pekka Mäntyselkä, M.D., Ph.D., and the team in the Unit of Primary Health Care of Kuopio University Hospital for his support in the early phases of this study. Many thanks to Matti Pietikäinen, M.D., and Kalevi Savolainen, M.D., from Kuopio Health Centre for their positive attitude towards research and flexibility in terms of work arrangements. I also thank Jussi Kiuru, B.M., and Katja Lintu, M.D., for their help with the study data. My sincerest thanks go to all the patients who participated in this study and thus enabled it. I have been fortunate to be surrounded by inspiring and warm-­‐‑hearted friends, many of whom are also great researchers: Lena, Pirita, Pauliina, Inkeri, Anne-­‐‑Mari and Sanna-­‐‑
Kaisa. My warmest thanks to them for their friendship, support and advice. Many thanks also to my reference group from the medical school (‘Shätti’): Viltsu, Ville, Milla, Katja, Henrik, Mikael and Kukka for providing me with the best possible distraction from work and a lot of laughter. I am deeply grateful to my parents Ansa and Jaakko for their encouragement and support throughout my life. In the last few years of this project their input has been very XII practical involving a lot of diaper changing. I also wish to thank my brother Taneli and his family as well as my parents-­‐‑in-­‐‑law, Marjatta and Juha, for all their help and support. And finally thanks to my husband Teppo and our son, for their love, patience, encouragement and belief in me. This study has been financially supported by EVO and VTR grants from Kuopio University Hospital and a grant from the North Savo Regional Fund of the Finnish Cultural Foundation. The Department of Clinical and Rehabilitation Medicine of Kuopio University Hospital has provided the facilities and personnel for the intervention. My sincerest thanks to all the parties for enabling this work. Helsinki, July 2015 Eeva-­‐‑Eerika Helminen !--!--"!
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Abbreviations,
,
ACR,,
PSEQ,
American,College,of,
Rheumatology,
Pain,Self9Efficacy,
Questionnaire,
AE,
Arthritis,education,
RAND936, RAND,369Item,Health,Survey,
AE9SS,
Arthritis,education,with,
RCT,
Randomized,controlled,trial,
spousal,support,
SA,
Spouse9assisted,
BAI,,
Beck’s,Anxiety,Inventory,
SC,
Standard,care,
BDI,
Beck’s,Depression,Inventory,
SD,
Standard,deviation,
BMI,
Body,mass,index,
SF936,
Medical,Outcome,Study,369
CB,
Cognitive9behavioural,
Item,Short9Form,Health,
CI,
Confidence,interval,
Survey,
CST,
Coping,skills,training,
SOC,
Sense,of,Coherence,
GAC,
Global,assessment,of,change,
TKA,
Total,knee,arthroplasty,
GP,
General,practitioner,
TSK,
Tampa,Scale,of,Kinesiophobia,
HRQoL,
Health9related,quality,of,life,
VAS,
Visual,analogue,scale,
KL,
Kellgren9Lawrence,
WOMAC, Western,Ontario,and,
osteoarthritis,grading,scale,
McMaster,Universities,
LS,
Life,Satisfaction,
Osteoarthritis,Index,
MCS,
Mental,component,summary,
MRI,
Magnetic,resonance,imaging,
NPRS,
Numeric,pain,rating,scale,
NSAID,
Non9steroidal,anti9
inflammatory,drug,
OA,
Osteoarthritis,,
PC,Scale,
Pain,Catastrophizing,Scale,
PCS,
Physical,component,
summary,
PCST,
,
Pain,coping,skills,training,
15D,
Generic,15D,instrument
!
,
,
,
,
XVIII!
1 Introduction Osteoarthritis (OA) is the leading cause of recurring knee pain in people over 50 years old (Felson et al. 2000). At the individual level, persistent pain due to knee OA can be limiting in many ways leading to a loss of function and reduced quality of life (Salaffi et al. 2005), and psychological disability (Scopaz et al. 2009). Knee OA imposes an increasingly heavy economic burden on social welfare and health care systems due to surgical and medical interventions and frequent absenteeism from work (Bitton 2009). While only about 10% of knee OA patients are ever to be considered for knee surgery (Peat et al. 2001), the annual costs in 2003 of knee joint replacement surgery were nearly € 50 million in Finland (Remes et al. 2007). Furthermore, OA accounts for 6% of all paid disability pensions in Finland, and the estimation for its direct and indirect costs are nearly one billion euros per year (Heliövaara and Paavolainen 2008). Traditionally, OA pain has been evaluated from a biomechanical point of view. This perspective places emphasis on joint damage and the degree of inflammation, which are addressed through pharmacological and surgical treatments. While surgical and pharmacological treatments clearly benefit many patients with OA, clinical observations have revealed several discrepancies. For instance, reports of pain can be dramatically different between patients with similar degrees of joint damage (Bedson and Croft 2008) or patients may respond quite differently to total knee arthroplasty (TKA) (Brander et al. 2003). Over the past 30 years, an increasing amount of evidence has emerged of psychological factors having an important role in OA patients’ reports of pain and coping. Thus, emotions, cognitions and social context variables are useful in understanding OA pain. Evolution in the field of pain research has led to the development of new theories and models, such as the cognitive-­‐‑behavioural (CB) model (Turk et al. 1983), which recognizes the potential involvement of psychological factors in pain. The model emerged in the 1970s and can be considered as the most influential model of the current psychological perspective on pain. Furthermore, the model has stimulated substantial research and has led to the development of psychological approaches to treat pain. As the fundamental cause of OA remains unresolved and the progression of the disease after onset is poorly understood (Brandt et al. 2006), the options for treatment are limited. Thus, the focus of conservative treatment of knee OA is in the reduction of pain and improvement of disability (Arokoski et al. 2012, Brown 2013, Hochberg et al. 2012, McAlindon et al. 2014, National Clinical Guideline Centre 2014). However, many unanswered questions remain concerning psychological interventions targeted at pain reduction. There have been only a limited number of randomized controlled trials (RCTs) with psychological interventions. The aim of the present study was to examine the effect of a group-­‐‑based CB intervention by Linton (2005b) on knee OA pain patients in a RCT with a one-­‐‑year follow-­‐‑
up. Psychological factors (emotions, resource factors, fear of movement and catastrophizing) and their impact on patients’ perceptions of pain and function were also investigated. 2 3 2 Review of Literature 2.1 PATHOGENESIS OF KNEE OSTEOARTHRITIS
2.1.1 Pathophysiology Osteoarthritis (OA) can be considered as a condition in which the balance of degenerative and regenerative processes in joint structures has been disrupted. Changes in articular cartilage are important in the description of early phases of OA pathogenesis. Ultimately the disease affects all joint tissues, including cartilage, bone, synovium and periarticular soft tissues (Goldring and Goldring 2007). The formation of osteophytes and subchondral cysts as well as episodic synovitis, a thickened joint capsule and muscle weakness are all typical changes in knee OA (Arokoski et al. 2000, Buckwalter 1995, Buckwalter and Mankin 1998). Biochemically, the progression of OA can be viewed as a process whereby deterioration of the extracellular matrix starts to predominate over cartilage repair activities (Goldring and Goldring 2007). Early signs of OA in cartilage are a decrease in the superficial proteoglycan content, a deterioration in superficial collagen fibrils and an increase in the water content, which results in diminished cartilage stiffness (Buckwalter and Mankin 1998). Later on, the chondrocytes accelerate the synthesis of cartilage matrix proteins leading to the increased destruction of components in the extracellular matrix. Concurrently, calcified cartilage and subchondral bone become thicker as a result of the accelerated formation and resorption of the subchondral bone (Arokoski et al. 2000, Buckwalter 1995). Ultimately, the degenerative process due to the declined concentration of proteoglycans and collagen fibrillation exceeds the repair capabilities of chondrocytes resulting in splits in the cartilage extending down to bone. This degenerates the cartilage to the point of no return (Arokoski et al. 2000, Buckwalter 1995). In the osteoarthritic joint, the local inflammation reaction increases the production of cytokines and other inflammatory mediators. These are particularly produced by chondrocytes, but also by leukocytes in the synovium as well as osteoblasts and osteoclasts in the bone (Goldring and Goldring 2007). In articular cartilage, proteolytic catabolism is accelerated. Matrix metalloproteases degenerate proteoglycans and the collagen network of the extracellular matrix (Goldring and Goldring 2007). These metalloproteases are triggered by inflammatory cytokines, such as interleukin-­‐‑1 and tumour necrosis factor-­‐‑α, nitric oxide and synovial inflammatory transmitters. Adipokines, produced by adipose tissue, have been identified as regulatory factors in OA-­‐‑related inflammation (Gomez et al. 2011, Neumann et al. 2011), and may act as a biochemical link between obesity and OA (Koskinen et al. 2011, Vuolteenaho et al. 2009). 2.1.2 Risk factors Knee OA is a disease caused by multiple interrelated factors that contribute to a cascade leading to joint degeneration. However, the fundamental cause of OA remains unknown (Brandt et al. 2006). Nevertheless, there are several risk factors that have been demonstrated to have a clear association with knee OA (Table 1). These risk factors can be grouped into systemic and local biomechanical factors. Some of them fit both of these categories. For instance, obesity can cause systemic metabolic changes as well as increased biomechanical stress locally in the knee joint. Aging is indisputably the most important risk factor for knee OA. OA is the leading cause of recurring knee pain in people over 50 years old (Felson et al. 2000) and its global age-­‐‑standardised prevalence is estimated at 3.8% (Cross et al. 2014). In Finland, according to Health 2000 examination survey, the prevalence of knee OA is 0.3% in men and 0.4% in 4 women aged under 45 years, while the respective figures among 75–84-­‐‑year-­‐‑olds are 15.6% and 32.1%. It is noteworthy, however, that the prevalence of knee OA in women over 30 years has halved during the past 20 years (Aromaa and Koskinen 2004). There is a large body of evidence demonstrating the role of obesity as a risk factor for knee OA. In the light of recent biochemical research the effect of obesity appears to be mediated through both mechanical and metabolic pathways (Koskinen et al. 2011, Vuolteenaho et al. 2009). Being overweight or obese is associated with a 4-­‐‑ to 5-­‐‑fold increased risk of knee OA (Anderson and Felson 1988). Obesity also forms a major risk factor for the incidence of bilateral knee OA (Spector et al. 1994). According to a meta-­‐‑
analysis, the body mass index (BMI) was significantly positively associated with the knee OA risk. A 5-­‐‑unit increase in the BMI was associated with a 35% increased risk of knee osteoarthritis. The magnitude of the association was significantly stronger in women than that in men (Jiang et al. 2012). There is strong evidence that joint injury is associated with an elevated risk of knee OA (Roos 2005): the risk of developing knee OA after injury is 3-­‐‑ to 4-­‐‑fold higher among women and 5-­‐‑ to 6-­‐‑fold higher among men when compared to healthy controls (Felson and Zhang 1998). Injuries to the anterior cruciate ligament are most recognizably associated with the incidence of knee OA (15–20%). Furthermore, total meniscectomy elevates the relative risk of knee OA to 14.0 after 21 years (Roos et al. 1998), and partial meniscectomy may also be a significant factor in the development of knee OA (Cooper et al. 1994, Manninen et al. 2002). Heavy physical activity and occupational load are important biomechanical risk factors for the incidence of knee OA (Vignon et al. 2006). Concerning heavy physical activity, the risk of knee OA may particularly increase among obese individuals (McAlindon et al. 1999). Conversely, regular and moderate physical exercise has been shown to be associated with a decreased risk of knee OA (Manninen et al. 2001). With respect to occupational load, it appears that the risk of knee OA may be especially high for those activities involving both knee bending and mechanical loading (Cooper et al. 1994, Manninen et al. 2002). Knee malalignment has also been shown to be associated with the development and progression of knee OA (Hunter et al. 2009). Finally, the role of genetic factors is estimated to explain from 39% to 65% of the disease independently of the known environmental and demographic confounders (Neame et al. 2004, Spector et al. 1996a), suggesting that the articular cartilage of some individuals is congenitally more susceptible to stress. 5 Table 1. The risk factors of knee osteoarthritis (Arokoski et al. 2012).
Risk factor
Evidence
References
Female gender
+++
(Blagojevic et al. 2010, Srikanth et al. 2005)
Age
+++
(Anderson and Felson 1988, Blagojevic et al. 2010, Hart et al.
Obesity
+++
1999)
(Cicuttini et al. 1996, Cooper et al. 2000, Felson et al. 1988, Jiang
et al. 2012, Manninen et al. 1996, Manninen et al. 2002, Muthuri
et al. 2011, Toivanen et al. 2010)
Knee Injury
+++
(Cicuttini et al. 1996, Cooper et al. 2000, Felson et al. 1988, Jiang
et al. 2012, Manninen et al. 1996, Manninen et al. 2002, Muthuri
et al. 2011, Toivanen et al. 2010)
Heavy physical activity
++
(Chakravarty et al. 2008, Felson et al. 2007, Hannan et al. 1993,
Kujala et al. 1994, McAlindon et al. 1999, Michaelsson et al. 2011,
Spector et al. 1996b)
Occupational load
++
(Jensen 2008, Manninen et al. 2002, McWilliams et al. 2011,
Toivanen et al. 2010)
Meniscectomy
+
(Andersson-Molina et al. 2002, Blagojevic et al. 2010, Englund et
al. 2003, Papalia et al. 2011, Roos et al. 1998)
Genetic factors
++
Malalignment
++
(Chitnavis et al. 1997, Neame et al. 2004, Spector et al. 1996a,
Valdes and Spector 2011)
(Cerejo et al. 2002, Sharma et al. 2001, Sharma et al. 2010,
Tanamas et al. 2009)
+++, strong evidence; ++, moderate evidence; +, weak evidence
2.2 SYMPTOMS OF KNEE OSTEOARTHRITIS
2.2.1 Symptoms The key symptom in knee OA is pain, which is generally related to joint use and relieved by rest. In the progression of OA, pain may become more persistent and also appear at rest and during the night. Knee OA pain symptoms appear to deteriorate slowly, with limited evidence of worsening after three years of follow-­‐‑up (van Dijk et al. 2006). Knee OA patients report two types of pain: a dull, aching pain that develops into being constant over time, and less frequently, short episodes of more intense, unpredictable, emotionally draining pain (Hawker et al. 2008). The fundamental mechanisms of pain production in OA are not clear. The disease process affects all intracapsular and periarticular tissues of the joint leading to a number of possible sources of pain. The articular cartilage, as such, is an aneural and avascular tissue but the other joint tissues are richly innervated (O’Reilly and Doherty 2003). Loss of physical functioning is also a central symptom in knee OA patients. The disability can be wide-­‐‑ranging and affect various aspects of life. Traditionally, the main contributors to disability are believed to include pain, a reduced range of joint movement and muscle weakness (McAlindon et al. 1993, O’Reilly and Doherty 2003). There is limited evidence of worsening of the functional status after three years (van Dijk et al. 2006). Another common feature of knee OA is stiffness, which is typically present in the morning. As opposed to the prolonged morning stiffness in rheumatoid arthritis, it is usually relatively short-­‐‑lived in knee OA. Later in the day knee OA patients report symptoms of stiffness such as difficulty in rising from a chair, slowness of movements and clumsiness (Altman et al. 1986). 6 2.2.2 Attributes and determinants of pain and function There is an emerging consensus that the degree of knee pain and disability symptoms among OA patients appears to rest upon a complex interaction of factors, including structural damage, peripheral and central pain processing mechanisms, obesity, culture, and demographic as well as psychosocial factors (Creamer and Hochberg 1997, Creamer et al. 2000). For instance, in the European Project on Osteoarthritis (Edwards et al. 2014) advanced age, female gender, lower educational attainment and higher BMI were independently associated with disability. Furthermore, according to a study by Somers et al. (2009b) increased BMI was not only related to reports of greater pain but also to increased physical and psychological disability among knee OA patients. Thus, some of these factors appear to act as risk factors for symptomatic knee OA. With respect to structural damage, it has been shown that pain does not always accompany radiological findings of knee OA (Bagge et al. 1991, Hochberg et al. 1989). According to a systematic review, 15–81% of people with radiological knee OA have associated pain symptoms (Bedson and Croft 2008). The radiographic severity of knee OA has been reported to have weak or no association with disability in these patients (Davis et al. 1992, Odding et al. 1998). Pisters et al. (2012) studied the risk factors of functional decline over a five-­‐‑year follow-­‐‑
up. They concluded that, avoidance of activities, increased pain, greater comorbidity, a higher age, a longer disease duration, and reduced muscle strength and range of joint motion at baseline predicted more future limitations in activities in knee OA patients. A study by Zullig et al. (2014) also provided evidence that the comorbidity burden, particularly activity-­‐‑limiting conditions among knee and hip OA patients, was associated with worse patient-­‐‑related outcomes. Increasing evidence has suggested the importance of psychological (affective, cognitive, behavioral) variables in explaining and assessing osteoarthritis pain and disability (Phyomaung et al. 2014, Somers et al. 2009a, Urquhart et al. 2015). A population-­‐‑
based survey of individuals living in 17 countries revealed that depression and anxiety disorders occurred significantly more often among those with self-­‐‑reported arthritis. The pooled estimates of age-­‐‑ and sex-­‐‑adjusted odds ratios were approximately 1.9 for mood disorders among persons with versus those without arthritis (He et al. 2008). In a study by Smith and Zautra (2008) among women with OA, measures of anxiety and depression emerged as independent and significant predictors of current and next week pain, with anxiety having almost twice the effect of depression. Rosemann et al. (2008) examined factors associated with pain perception among OA patients in primary care. They concluded that the severity of depression had the strongest association with pain intensity. Furthermore, association with lower limb functional impairment, a lower educational level and weak social network, as well as pain intensity were also reported. A one-­‐‑year follow-­‐‑up study on knee OA patients by Axford et al. (2008) found that greater pain was associated with a reduced ability to cope, increased depression and reduced physical ability. A retrospective analysis from the longitudinal World Mental Health Survey revealed that individuals who had depressive or anxiety disorders during childhood were at substantially increased risk of arthritis as adults (Von Korff et al. 2009). These effects were maintained after adjustment for the effects of childhood adversities (childhood abuse, domestic violence, parental divorce and economic adversity). During recent decades, numerous studies have supported the importance of pain catastrophizing in predicting pain, disability and psychological distress (Edwards et al. 2006). Pain catastrophizing refers to “the tendency to focus on and magnify pain sensations to feel helpless in the face of pain” (Keefe et al. 2001). Somers et al. (2009b) reported in a cross-­‐‑sectional setting that pain catastrophizing explained a significant proportion of variance in measures of pain, psychological disability, physical disability and gait velocity in overweight and obese patients with knee osteoarthritis. Among knee OA patients 7 scheduled for total knee replacement surgery pre-­‐‑surgical pain and pain catastrophizing emerged as predictors of pain reports on 6-­‐‑week follow-­‐‑up (Sullivan et al. 2009). Self-­‐‑efficacy describes the belief that one has the capability to achieve a desired outcome such as control one’s pain. Pells et al. (2008) argued that among overweight and obese OA patients self-­‐‑efficacy is domain-­‐‑specific (e.g. self-­‐‑efficacy for pain is most strongly related to pain). Furthermore, they found that domain-­‐‑specific self-­‐‑efficacy mediated the relationship between pain catastrophizing and pain (Shelby et al. 2008). Marks et al. (2007a) also observed a correlation between self-­‐‑efficacy for pain control and knee pain in a cross-­‐‑
sectional study among knee OA patients. Sense of coherence (SOC) (Antonovsky 1993) describes the extent to which one has a feeling of confidence that one’s environment is predictable and that things will work out as well as can reasonably be expected. Among chronic pain patients, a high score on the SOC subscale “meaningfulness” was related to a better therapeutic outcome and better response to treatment in terms of pain intensity (Petrie and Azariah 1990). In a study by Benz et al. (2013), SOC was associated with psychosocial health dimensions, but hardly with physical health among patients with knee or hip OA. Life satisfaction (Allardt 1973, Koivumaa-­‐‑Honkanen et al. 2000, Koivumaa-­‐‑Honkanen et al. 2001) represents a more general aspect of psychological well-­‐‑being and positive health that has been found to be a powerful predictor of various health risks and health-­‐‑related adversities among persons with musculoskeletal disorders, such as the length of sick-­‐‑leave (Lydell et al. 2011) and poorer postoperative recovery (Sinikallio et al. 2011). In community-­‐‑
dwelling adults, knee OA has been independently associated with lower life satisfaction (Yang et al. 2015). 2.3 CLINICAL AND RADIOLOGICAL FINDINGS AND DIGNOSTIC
CRITERIA
2.3.1 Clinical findings Common clinical findings in knee OA patients include limping, a slowed walking speed, and a decreased range of motion. In advanced stages of knee OA, the joint usually becomes deformed and there may be detectable varus or valgus instability. Coarse crepitus is thought to demonstrate the loss of congruency of the joint (O’Reilly and Doherty 2003). The joint can be tender in palpation. Heat, pain and effusion in the joint area point to synovitis in knee OA. A reduced range of motion is considered to be caused by osteophyte formation, remodelling, capsular thickening, and can be emphasized by soft tissue edema. Muscle weakness can be present in knee OA but is difficult to examine. Laboratory tests can be helpful in the differential diagnosis but do not play any role in OA diagnosis as such (Arokoski et al. 2012, O’Reilly and Doherty 2003). 2.3.2 Radiological findings The plain radiograph remains the primary method of imaging in the diagnosis and severity assessment of knee OA (Arokoski et al. 2012). The advantages of radiography are clear, including cost-­‐‑effectiveness, safety, and excellent availability. Typical radiographic features in knee OA are joint space narrowing, osteophytes, subchondral bone sclerosis, cyst formation and bone deformity. Radiography, however, is rather insensitive at detecting early signs of knee OA. Thus, magnetic resonance imaging (MRI) is more suited for detecting the early phases of knee OA (Hayes et al. 2005). However, MRI reveals lesions in the tibiofemoral joint in most (89%) aged and elderly people in whom knee radiographs do not show any feature of OA, regardless of pain (Guermazi et al. 2012). In a population-­‐‑
based cohort study of knee pain patients (Cibere et al. 2011), a low OA progression rate was detected in MRI over three years, and radiographic severity was a significant predictor of OA progression. 8 There is an abundance of radiological classification systems for assessing the severity of knee OA, including those by Ahlbäck (1968), Nagaosa (2000), and Kellgren and Lawrence (KL) (1957) to mention a few. The most popular, however, is the KL grading scale, in which 0 refers to no OA and 4 indicates the most severe OA (Table 2). The reproducibility of KL grading for knee OA appears to be good or excellent (Gunther and Sun 1999), and it has been shown to correlate with MRI in cartilage defects, osteophytes and joint effusion (Hayes et al. 2005). Table 2. Radiographic classification of knee OA according to the Kellgren-Lawrence scale
(Kellgren 1963).
KL1 (doubtful)
Doubtful joint space narrowing and possible osteophyte lipping
KL2 (minimal)
Definite osteophytes and possible joint space narrowing
KL3 (moderate)
Moderate multiple osteophytes, definite joint space narrowing and some sclerosis,
and possible deformity of bone ends.
KL4 (severe)
Large osteophytes, marked joint space narrowing, severe sclerosis and definite
deformity of bone ends
2.3.4 Criteria for diagnosis Several sets of diagnostic criteria have been presented for knee OA. They usually rest upon radiographic findings, clinical findings, or a combination of these (Arokoski et al. 2012). The agreement between clinical and radiographic methods for knee OA diagnosis appears to be moderate (Toivanen et al. 2007). When clinical, laboratory and radiographic factors are combined, the sensitivity and specifity of a knee OA diagnosis are reported to be 94% and 88%, respectively (Altman et al. 1986). Hence, the use of combine radiographic and clinical criteria has been recommended in the diagnosis of knee OA (Altman et al. 1986, Arokoski et al. 2012) (Table 3). Table 3. Combined radiographic and clinical diagnosis classification of knee OA (Altman et al.
1986).
Knee pain on most days of the prior month
AND
At least one of the following:
Age over 50 years
Morning stiffness less than 30 min in duration
AND
Osteophytes at joint margins (X-ray spurs)
2.4 CONSERVATIVE TREATMENT OF KNEE OSTEOARTHRITIS
Since the exact cause of knee OA remains unknown and there is currently no accepted way to prevent the disease or slow its progression, the goal in the management of knee OA is to reduce joint pain and stiffness and to maintain joint mobility and minimize disability. In recent years, several organizations have updated their treatment guidelines for knee OA. All in all, they suggest a combination of pharmacological and non-­‐‑pharmacological interventions as the optimal first-­‐‑line management strategy for knee OA (Arokoski et al. 2012, Brown 2013, Hochberg et al. 2012, McAlindon et al. 2014, National Clinical Guideline Centre 2014, Nelson et al. 2014). 9 2.4.1 Self-­‐‑management education programmes Self-­‐‑management education programmes cover a variety of complex interventions expressly targeted at patient education and behaviour modification. They are designed to encourage people with chronic conditions to take an active self-­‐‑management role to supplement medical care and improve outcomes. The techniques include advice for exercise training, weight loss, different pain management techniques and the appropriate use of aids, as well as education concerning different aspects of OA and the social as well as cognitive aspects of the disease. A recent Cochrane systematic review (Kroon et al. 2014) on OA self-­‐‑management programmes included 29 RCTs in the meta-­‐‑analysis. The studies by Keefe et al. and Calfas presented in Table 4 were among these trials. The review found low to moderate quality evidence indicating that self-­‐‑management education programmes result in no or small benefits in people with OA, but are unlikely to cause harm. It also concluded that compared with attention control, these programmes probably do not improve self-­‐‑management skills, pain, OA symptoms, function or quality of life, and have unknown effects on positive and active engagement in life. Furthermore, when compared with the usual care, they may slightly improve self-­‐‑management skills, pain, function and symptoms, although these benefits are of unlikely clinical importance. Finally, it was stated that further studies investigating the effects of self-­‐‑management education programmes, as delivered in the trials in this review, are unlikely to substantially change the conclusions, as confounding from biases across studies would have probably favoured self-­‐‑management. 2.4.2 Exercise The goals of exercise treatments are to use active and functional techniques to improve the functional status of patients and reduce pain and other symptoms of OA. Exercise therapies have included strengthening, stretching, range-­‐‑of-­‐‑motion and aerobic exercises. A recent Cochrane review (Fransen et al. 2015) on land-­‐‑based exercise found high-­‐‑quality evidence that land-­‐‑based therapeutic exercise provides short-­‐‑term benefit that are sustained for at least two to six months after the cessation of formal treatment in terms of reduced knee pain, and moderate-­‐‑quality evidence shows improvement in physical function among people with knee OA. The magnitude of the treatment effect could be considered moderate to small, but comparable with estimates reported for non-­‐‑steroidal anti-­‐‑inflammatory drugs (NSAIDs). In terms of aquatic exercise, a recent review (Lu et al. 2015) concluded that studies in this area are still too scarce and too short term to provide further recommendations on how to apply this therapy. At this point, aquatic exercise can be considered as an adjuvant treatment for patients with knee OA. A systematic review by Jansen et al. (2011) examined the effects of strength training alone, exercise alone and exercise combined with passive manual mobilisation on pain and function in knee OA patients. They reported that exercise therapy plus manual mobilisation showed a moderate effect size (0.69, CI 0.42−0.96) on pain compared to the small effect sizes for strength training (0.38, CI 0.23−0.54) or exercise therapy alone (0.34, CI 0.19−0.49). A systemic review and meta-­‐‑regression analysis by Juhl et al. (2014) on the impact of dose and exercise type on knee OA patients concluded that single-­‐‑type exercise programmes were more efficacious than programmes that included different exercise types. More pain reduction occurred with quadriceps-­‐‑specific exercise than with lower limb exercise, and when supervised exercise was performed at least 3 times a week. The review reported similar results for the effect on patient-­‐‑reported disability. 2.4.3 Weight management Research has demonstrated that increased weight contributes to the development and progression of OA and negatively impacts on adjustment to OA pain and disability (Hartz et al. 1986). Several treatment guidelines recommend weight management programmes for overweight or obese knee OA patients (Arokoski et al. 2012, Brown 2013, Hochberg et al. 10 2012, McAlindon et al. 2014, National Clinical Guideline Centre 2014, Nelson et al. 2014). Weight loss can be achieved by conventional methods (reduced calorie intake and increased exercise), as well as pharmacological or surgical treatments. A systematic review and meta-­‐‑analysis (Christensen et al. 2007) on the effect of weight loss in obese knee OA patients reported a pooled effect size for pain and physical disability of 0.20 (95% CI 0−0.39) and 0.23 (0.04−0.42) respectively, with a weight reduction of 6.1 kg (4.7−7.6 kg). Meta-­‐‑
regression analysis revealed that disability could be significantly improved when weight was reduced by over 5.1%, or at the rate of a >0.24% weight reduction per week. Furthermore, in the treatment of knee OA, combining exercise and weight-­‐‑loss treatments shows a greater effect on pain and functionality than does exercise or dietary weight loss alone (Messier et al. 2004), and the combined treatment is also the most cost-­‐‑effective (Sevick et al. 2009). Cristensen et al. (2005) conducted an RCT on knee OA patients testing the effects of a low-­‐‑energy diet (3.4 MJ a day) for eight weeks. At the end of the trial, weight loss was greater in the treatment group compared with the control group (11.1% vs. 4.3%). They reported a significantly lower overall Western Ontario and McMaster Universities (WOMAC) Osteoarthritis index, as well as WOMAC function subscale for the intervention group. Furthermore, Riecke et al. (2010) conducted an RCT of 16 weeks comparing the effects of a low-­‐‑energy diet an very-­‐‑low-­‐‑energy diet in knee OA patients. They reported that there were no significant differences between the groups in terms of weight reduction, quality of life or number of clinical responders. Finally, massive weight loss after bariatric surgery may reduce pain and stiffness, as well as improve function (Lyytinen et al. 2013, Richette et al. 2011). 2.4.4 Pharmacological modalities The most common approach to the treatment of OA in primary care is the prescription of painkillers (Bertin et al. 2013). Guidelines have consistently recommended paracetamol as the first-­‐‑line analgesic for OA patients (Arokoski et al. 2012, Hochberg et al. 2012, McAlindon et al. 2014, Nelson et al. 2014). However, there was controversy in retaining the recommendation in the latest guideline from the National Institute for Health and Care Excellence (National Clinical Guideline Centre 2014), mainly because several studies have reported small effects of paracetamol compared with placebo (Towheed et al. 2006, Zhang et al. 2010). A systematic review and meta-­‐‑analysis (Machado et al. 2015) concluded that paracetamol provides minimal short-­‐‑term benefits for people with OA. These results support the reconsideration of recommendations to use paracetamol for patients with OA of the hip or knee in clinical practice guidelines. If the efficacy of paracetamol is not adequate, NSAIDs are recommended (Arokoski et al. 2012, McAlindon et al. 2014). They should be used for a short period of time with the lowest effective dose. In clinical trials, the analgesic power of traditional COX-­‐‑1 and COX-­‐‑2 selective NSAIDs has not differed significantly (Chen et al. 2008, Watson et al. 1997). Hence, the preparation should be selected on the basis of its safety profile and patient’s risk factors (e.g. cardiovascular and gastrointestinal). Topical NSAIDs are recommended as the first-­‐‑line pain medication in mild to moderate knee OA (McAlindon et al. 2014, National Clinical Guideline Centre 2014). Their analgesic effect has been shown to be equal to that of oral NSAIDs, while their safety profile is far better (Chou et al. 2011). For those patients not receiving adequate pain relief from paracetamol or NSAIDs, opioids are recommended (Arokoski et al. 2012, McAlindon et al. 2014). When choosing the preparation, weak opioids should be favoured even if OA pain is severe. A Cochrane review and meta-­‐‑analysis concluded that the small to moderate beneficial effects of non-­‐‑
tramadol opioids are outweighed by a large increase in adverse events (e.g. nausea, constipation, dizziness, somnolence, vomiting) (Nuesch et al. 2009). Intra-­‐‑articular glucocorticoids are recommended in case other means of analgesia have failed and there is evidence of inflammation (swelling). They provide short-­‐‑term (2−4 weeks) pain relief 11 (Bellamy et al. 2006) but do not have any effect on the progression of knee OA (Raynauld et al. 2003). Most clinical guidelines (Brown 2013, Hochberg et al. 2012, National Clinical Guideline Centre 2014) do not recommend the use of intra-­‐‑articular hyaluronate, oral glucosamine or chondroitin. The recommendations concerning capsaicin remain contradictory. 2.5 THE COGNITIVE-BEHAVIOURAL FRAMEWORK IN PAIN PSYCHOLOGY
2.5.1 Theory The CB perspective presented by Turk et al. (1983) is the most widely accepted model in the field of pain psychology. The CB approach to chronic pain is based on several propositions (Keefe et al. 1992, Turk and Rudy 1992), the central one being that an individual'ʹs emotions and behavioural activity in response to an event are influenced by the cognitive appraisal and interpretation of that event. The CB perspective on pain grew out of developments in pain theory dating back to Melzack and Wall'ʹs gate control theory (1965). The gate control theory has two main principles. Firstly, the gating mechanism in the dorsal horn of the spinal cord can control the transmission of nociceptive signals from a peripheral site to the brain. Secondly, the spinal gating of noxious signals is controlled not only by input from the periphery, but also by input from higher brain centres responsible for thoughts, feelings, and behaviours. The gate control theory provides an explanation for why some psychological factors (e.g. active coping, optimism) can reduce pain while others (e.g. anxiety, depression) can increase pain. In rehabilitation, CB approaches aim to improve the way that individuals manage and cope with their pain. Rather than trying to find a biological explanation for the pain problem, CB treatments focus on returning control to the sufferer. Patients with chronic pain are viewed as active processors of information. They have negative expectations about their own ability and responsibility to exert any control over their pain. Moreover, they often view themselves as helpless. Such negative, maladaptive appraisals of their situation and their personal efficacy may reinforce the experience of demoralization, inactivity, and overreaction to nociceptive stimulation. Such cognitive appraisals and expectations are postulated as having an effect on behaviour, leading to reduced effort and activity as well as increased psychological distress (Turk and Rudy 1992). CB treatments for pain commonly cover three main elements (Dixon et al. 2007). Firstly, they try to provide an educational rationale, such as the gate control theory (Melzack and Wall 1965), that helps the patients to better understand the interrelated nature of their thoughts, feelings, behaviour and pain perceptions. The second element is comprised of therapist-­‐‑guided training in cognitive and behavioural coping strategies such as progressive relaxation training, brief relaxation methods, goal setting, activity pacing, imagery, and strategies for modifying overly negative thoughts related to pain. The final element involves home practice of coping skills and learning how to apply these skills to pain-­‐‑related situations in daily life. With these methods, patients may feel that they regain control of their lives, and are able to do more and feel better. 2.5.2 Applications for knee osteoarthritis patients The drawing of conclusions on psychological interventions for knee OA is difficult due to the variability among previous studies, which have been heterogeneous in terms of the intervention (group or individual programmes, of different lengths), underlying theory and methods. In the recent Cochrane review (Kroon et al. 2014) on OA self-­‐‑management programmes many interventions included behavioural and cognitive components as a part of the programme but other conservative treatment modalities, such as exercise, were also incorporated. Thus, the impact and significance of the CB part of the intervention is difficult to determine. 12 Studies applying plain CB interventions for knee OA patients are presented in Table 4. All in all, seven out of eight studies have used an intervention called pain coping skills training (PCST), and at least partly the same researchers have been involved in them. One of the earliest studies was a three-­‐‑arm RCT testing a 10-­‐‑week group-­‐‑based PCST programme in comparison to arthritis educational (AE) classes and standard care (SC) (Keefe et al. 1990a, Keefe et al. 1990b). In this study, knee OA was diagnosed on the basis of medical evaluation and radiographic examination. However, more detailed information was not given on the radiographic findings or diagnostic criteria used. The results regarding pain reduction were short-­‐‑lived. There were significant differences between the PCST and AE groups in physical and psychological function in favour of the PCST group. Interestingly however, these differences were not present between PCST and SC groups. Next, Keefe et al. (1996, 1999) studied the efficacy of a group-­‐‑based spouse-­‐‑assisted coping skills training (SA-­‐‑CST) programme. Again, this was a three-­‐‑arm RCT with control groups attending CST without spousal involvement or 10 group sessions with arthritis education with spousal support (AE-­‐‑SS). The participants in this study were diagnosed as having OA, but the diagnostic criteria used were not specified. At the one-­‐‑year follow-­‐‑up, self-­‐‑efficacy and pain coping for the SA-­‐‑CST group were significantly better in comparison to the AE-­‐‑SS group. Once again, the reduction in pain was out washed during the follow-­‐‑
up. Later on, PCST was studied in a four-­‐‑arm RCT examining the effects of a 12-­‐‑week group-­‐‑based spouse-­‐‑assisted PCST (SA-­‐‑PCST) in combination with exercise training (ET) (Keefe et al. 2004). The participants had been diagnosed with OA of the knees and underwent a physical examination by a rheumatologist. Again, however, no exact information was given on the set of diagnostic criteria used. The combined intervention group (SA-­‐‑PCST + ET) demonstrated significant pretest-­‐‑posttest differences in self-­‐‑efficacy and pain coping in comparison to ET and SC interventions alone. No follow-­‐‑up data have been published from this study. Riddle et al. (2011) performed a quasi-­‐‑experimental study among patients scheduled for primary knee arthroplasty and with high initial catastrophizing scores measured with the PC scale (Riddle et al. 2010). The comparison was with a historical cohort scheduled for knee arthroplasty and receiving usual care. The radiological severity of their knee OA was not reported, but considering the setting, one can assume that they were mostly KL3−4. Two months after the surgery, the study demonstrated significantly better improvements in pain, physical function and pain catastrophizing for the PCST group compared to a historical cohort. Somers et al. (2012) conducted a four-­‐‑arm RCT with a combined PCST and behavioural weight management (BWM) intervention. The PCST intervention in this study was particularly long lasting for one year with 18 group sessions and 6 monthly phone calls. The participants had to fulfil the ACR clinical criteria for knee OA and have KL1−4 radiological knee OA. The results were analysed with the mixed model and the combined intervention group achieved significantly better results (post-­‐‑treatment average) compared to all other study groups for pain improvement, physical function, self-­‐‑efficacy and catastrophizing. Comparisons between the single PCST intervention and SC were not reported. However, considering the post-­‐‑treatment average levels of different pain and function measures, there were probably no significant differences. Recent studies using PCST as an intervention have addressed questions of its accessibility. Firstly, the effectiveness of an individual PCST programme held by trained primary care nurse practitioners was tested (Broderick et al. 2014). The participants had to have knee or hip OA confirmed by their physician. Radiographs were evaluated at baseline, but even KL0 was accepted. Follow-­‐‑up results revealed significantly better outcomes for the PCST group in pain reduction, physical function, psychological function, pain coping and catastrophizing. In this study, particular emphasis was placed on educating and reaffirming the adherence of the nurse practitioners to the programme. The most recent study by Rini et al. (2015) was an RCT pilot for testing the effectiveness of an 13 eight-­‐‑week Internet-­‐‑based PCST programme in patients with ≥KL2 knee or hip OA. Initial improvements in pain reduction for women and self-­‐‑efficacy for the intervention group were reported, but since the study was a pilot, it did not have sufficient statistical power for any further conclusions. Finally, both of these studies included patients with hip or knee OA, and thus the effect of the intervention on knee OA patients is difficult to decipher, since they were not analysed separately. The remaining study testing a group-­‐‑based CB intervention on OA patients was conducted in the early 1990s by Calfas et al. (1992). In this two-­‐‑arm RCT, patients could have OA of any joint, and the number of patients with knee OA in the study was not reported. At the 2-­‐‑month follow-­‐‑up point, a significant difference was detected between the study groups, but the effect was washed out by the 12-­‐‑month follow-­‐‑up point. In summary, studies have demonstrated that a plain CB intervention has at most a short-­‐‑term impact on pain and function in the conservative treatment of knee OA patients. Heterogeneity remains in the results concerning psychological function, self-­‐‑efficacy and pain coping. From the point of view of knee OA patients, limitations in these studies include the lack of radiological verification of OA or its vagueness, and their inclusion of other OA joint groups. Inclusion criteria
1) Knee OA
diagnosed by
medical evaluation
and radiographic
examination; 2) no
other form of
arthritis or organic
disease
significantly
affecting function;
3) not receiving
disability support
payments for OA.
1) Adult; 2) OA
(any joint)
diagnosed by a
physician
according to the
American
Rheumatology
Association
criteria; 3) at least
“modest”
functional
impairment in one
or more functional
questions.
No. of
groups
3
2
Sample
size
99,
mean
age 64
years
40,
mean
age 67
years
Research
group,
study type,
country
Keefe et al.
(1990a,
1990b),
randomized
controlled
trial, USA
Calfas et al.
(1992),
randomized
controlled
trial (pilot
study, not
statistically
sufficient
power), USA
Outcome
assessment
Pretestposttest;
follow-up (6
months)
Pretestposttest;
follow-up (2,
6 and 12
months)
Control
1) 10 weekly
AE sessions
(n=36);
phone calls
at 1, 2 and 4
months
during the
follow-up
2) SC
(n=31)
AE (series of
didactic
lectures)
Intervention
Treatment
period: 10
weekly group
sessions of
PCST (n=32);
follow-up (6
months):
phone calls at
1, 2 and 4
months
10 weekly
group sessions
of CB
modification
Table 4. Studies with plain cognitive-behavioural interventions for knee OA patients.
1)
2)
3)
4)
5)
6)
AIMS
AIMS
AIMS, BDI
NA
NA
NA
Outcome
measures
1) Pain reduction
2) Physical function
3) Psychological
function
4) Self-efficacy
5) Pain coping
6) Catastrophizing
1) AIMS
2) AIMS
3) AIMS
4) NA
5) CSQ
6) NA
1) Pain reduction
2) Physical function
3) Psychological
function
4) Self-efficacy
5) Pain coping
6) Catastrophizing
Posttest:
1) PCST > AE and SC
2) NS
3) PCST > AE and SC
AE > SC
4) NA
5) NR
6) NA
Follow-up:
1) NS
2) PCST > AE
PCST vs. SC -> NS
3) PCST > AE
PCST vs. SC -> NS
4) NA
5) NR
6) NA
Follow-up 2 months:
1) NS
2) CB > AE
3) CB > AE (BDI)
4) NA
5) NA
6) NA
Follow-up 12 months:
1) NS
2) NS
3) CB > AE (BDI)
4) NA
5) NA
6) NA
Results
1) Diagnosed as
having knee OA;
2) persistent pain
due to knee OA;
3) having a
spouse.
4
72,
mean
age 60
years
Keefe et al.
(2004),
randomized
controlled
trial, USA
1) Married; 2)
diagnosed as
having OA of the
knees; 3) not
having any other
arthritic disorders
other than OA; 3)
no other known
organic disease
that would
significantly affect
function; 4) not
receiving disability
payments for OA.
3
88,
mean
age 63
years
Keefe et al.
(1996,
1999),
randomized
controlled
trial, USA
1)
2)
3)
4)
5)
6)
Pretestposttest
(week 12)
1) SA-PCST
2) PCST
alone
3) ET alone
4) SC
12 weekly
group sessions
of SA-PCST +
12 weekly
sessions of ET
AIMS
AIMS
AIMS
ASES
CSQ
NA
1) AIMS
2) AIMS
3) AIMS
4) ASES
5) CSQ (factors:
Coping Attempts,
Pain Control and
Rational Thinking)
6) NA
Pretestposttest;
follow-up (6
and 12
months)
1) CST
without
spousal
involvement
2) 10 weekly
group
sessions of
AE-SS
10 weekly
group sessions
of SA-CST
held by a
psychologist
and a nurse
Posttest:
1) SA-CST > AE-SS
2) NS
3) SA-CST > AE-SS
4) SA-CST and CST >
AE-SS
5) SA-CST > AE-SS
6) NA
Follow-up 12 months:
1) NS
2) CST > AE-SS
SA-CST vs. AE-SS ->
NS
3) NS
4) SA-CST > AE-SS
5) SA-CST > AE-SS
6) NA
Posttest:
1) NS
2) NS
3) NS
4) SA-PCST + ET >
ET and SC
SA-PCT alone > SC
5) SA-PCST + ET >
ET and SC
SA-PCT alone > ET
and SC
6) NA
1) Knee pain on
most days of the
month for at least
6 months; 2) ≥18
years old; 3) BMI
≥25 and ≤42; 4)
met the ACR
clinical criteria for
OA and had
radiological
evidence (KL 1-4)
of knee OA; 5) no
other weightbearing joint
affected by OA; 6)
knee OA was the
primary contributor
to the daily
function; 7) able to
read and speak
English.
4
232,
mean
age 58
years
Somers et
al. (2012),
randomized
controlled
trial, USA
1) Patients
scheduled for
primary unilateral
knee arthroplasty;
2) scored ≥16 on
the PC Scale; 3)
able to speak and
read English.
2
63,
mean
age 62
years
Riddle et al.
(2011),
quasiexperimental study,
USA
8 sessions of
PCST (n=18)
held by a
psychologist:
one individual
session a
month prior
and a month
following the
surgery, 6
telephonebased
sessions
between them
Treatment
period: 18 (12
weekly, 6
every other
week) group
sessions of
PCST and
BWM (n=62);
follow-up
period: 6
monthly
phone calls
1) AIMS, WOMAC
2) AIMS, WOMAC
3) AIMS
4) ASES
5) NA
6) CSQ
catastrophizing
subscale
Pretestposttest (6
months);
follow-up (6
and 12
months)
1) PCT alone
(n=60)
2) BWM
alone
(n=59)
3) SC
(n=51)
WOMAC
WOMAC
NA
NA
NA
PC Scale
1)
2)
3)
4)
5)
6)
Baseline;
follow-up (2
months after
surgery)
HC (n=45)
Baseline –
posttreatment
average:
1) PCTS + BWM > all
other study groups
(AIMS, WOMAC)
2) PCTS + BWM > all
other study groups
(AIMS, WOMAC)
3) NS
4) PCTS + BWM > all
other study groups
5) NA
6) PCTS + BWM > all
other study groups
Follow-up:
1) PCST > HC
2) PCST > HC
3) NA
4) NA
5) NA
6) PCST > HC
257,
mean
age 67
years,
knee OA
in 77%
(n=199)
2
Broderick et
al. (2014),
randomized
controlled
trial, USA
Pretest-posttest:
1) Composite
SC (n=127)
Pretest10 individual
1) Physician1) PCTS > SC
measure of AIMS,
posttest;
weekly
confirmed
Brief Pain Inventory, 2) PCTS > SC
follow-up (6
sessions of
diagnosis of hip or
3) PCTS > SC
WOMAC
and 12
PCST (n=129)
knee OA (KL 0-4);
4) PCTS > SC
2) Composite
months)
held by nurse
2) ≥21 years old;
5) PCTS > SC
measure of AIMS,
practitioners
3) usual pain ≥4
6) NS
WOMAC
on a 10-point scale
Follow-up 12 months:
3) Composite
of at least 6
1) PCTS > SC
measure of AIMS,
months; 4) ability
2) PCTS > SC
BDI
to read, write,
3) PCTS > SC
4) ASES
understand
4) NS
5) CSQ subscales
English; 5) ability
5) PCTS > SC
excluding the
to attend 10
6) PCTS > SC
catastrophizing
intervention
subscale
sessions; 6) no
6) CSQ
cognitive/mental
catastrophizing
impairment; 7) no
subscale
expected joint
replacement
surgery.
Pretest-posttest:
1) AIMS2
SC (n=55)
Pretest8-week (82
1) ≥18 years old;
113,
Rini et al.
1) PCST > SC for
2) AIMS2
midpoint (5
2) with hip or knee module)
mean
(2015),
women
3) Pain Anxiety
weeks)InternetOA, confirmed
age 67
randomized
2) NS
Symptoms Scale,
posttest
based PCST
radiographically
years,
controlled
3) NS
Positive and
programme
(KL≥2, with
knee OA
trial (pilot
4) PCST > SC
Negative Affect
(n=58)
associated pain),
35%
study, not
5) NA
Scale
with ACR clinical
(n=40),
statistically
6) NA
4) ASES
criteria, or by their
knee
sufficient
5) NA
physician; 3) able
power), USA and hip
6) NA
to speak English;
OA 52%
4) OA related pain
(n=59)
on most days of
the month for 3
months.
PCST, pain coping skills training; AE, arthritis education; SC, standard care; AIMS/AIMS2, Arthritis Impact Measurement Scale; NA, not assessed; CSQ,
coping skills questionnaire; NS, non-significant; NR, not recorded; CB, cognitive-behavioural; BDI, Beck’s Depression Inventory; SA-CST/-PCST, spouseassisted coping/pain coping skills training; AE-SS, arthritis education with spousal support; ASES, Arthritis Self-Efficacy Scale; CSQ, Coping Strategies
Questionnaire; PC Scale, Pain Catastrophizing Scale; ET, exercise training; HC, historical cohort; BMI, body mass index; BWM, behavioural weight
management; ACR, American College of Rheumatology; KL, Kellgren–Lawrence grade.
2.6 PAIN AND MEASURES OF PSYCHOLOGICAL WELL-BEING
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4.1 STUDY PATIENTS AND DESIGN
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(+1 '$'!$I!+'**+I, ,I I$I,'I '+(!,$!2,!'&I'*I&I!&!$!,1I,'I/'*#AI(*.!'-+I'*I
($&&I $'/*I 0,*%!,1I "'!&,I +-**1AI &I ', *I #I '*I $'/*I $!%I (!&I +1%(,'%+I , ,I
I&I%'*I*.,!&I, &I, I#&I(!&@I'*I!&$-+!'&AI, I(*,!!(&,+I$+'I I
,'I $*I , ,I , 1I /*I $I ,'I ,,&I :I !&,*.&,!'&I +++!'&+I &I (*+-%$1I '%($,I
, I+,-1@I
""%
%%%
I%"'*!,1I'I, I(,!&,+I/*I**-!,I*'%I(*!%*1I*I(*'.!*+I!&I, I
-'(!'I*I
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*I , I #&I *!'*( +I *'%I &I G*1I ,+I '*!&I ,'I , I I $++!!,!'&@I
', *I /!, I , !+I **-!,%&,I +,*,1AI .*,!+%&,+I *)-+,!&I (',&,!$I +,-1I
&!,+I ,'I '&,,I , I +,-1I ','*+I /*I ($I !&I , I !$!,!+I 'I $'$I (*!%*1I *I
(*'.!*+AI+I/$$I+I, '+I'I'-,(,!&,I$!&!+I,I
-'(!'I&!.*+!,1I'+(!,$@I*-!,%&,I
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'*I, I+,-1I/+I,*%!&I+I'&I, I(*$!%!&*1I)-+,!'&&!*I&I
I*!&I1I
, I+,-1I','*+@I'*I, I*&'%!2,!'&AI$$I, I(,!&,+I(*,!!(,I!&I*'-(+I'I64>69I
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','*+I&I*!.II''#$,I'*I(,!&,+I(*+&,!&I, I!&&!+ I-**&,I*I-!$!&+I
'&I #&I &I !(I I C*'#'+#!I ,I $@I 6456D@I ', I , I !&,*.&,!'&I &I , I '&,*'$I *'-(I
'&,!&-I+!I1I+!I/!, I, I-+-$II*I, ,I(,!&,+I%! ,I .I*!.I!&I(*!%*1I
*I, *'- '-,I, I+,-1@I
I(,!&,+I/*I*&'%$1I++!&I,'I!, *I, II*I&I!&,*.&,!'&I*'-(I'*I
, I I *I '&,*'$I *'-(@I I I *I /+I &',I !&,*.&I !&I &1I /1I 1I , I +,-1@I
&'%!2,!'&I /+I '&-,I !&I $'#+I 'I +!0AI +(*,$1I '*I %&I &I /'%&AI -+!&I I
'%(-,*G&*,I+)-&I, ,I/+I'&+,*-,I1II'$$'*,'*I/ 'I!I&',I%,I, I
+,-1I (,!&,+@I )-&,!$$1I &-%*I +$I '()-I &.$'(+I /*I -+I !&I !,+I
%!&!+,*,!'&@I I+,-1I','*+I/*I$!&I,'I, I*'-(I++!&%&,I&I!I&',I,#I
(*,I!&I(*'.!!&I, I!&,*.&,!'&+@I I'I'*I*&'%!2,!'&I/+I'&$1I'(&I,*I, I
+,,!+,!$I&$1++I I&I(*'*%I,*I, I56G%'&, I'$$'/G-(I('!&,@I
%
%
%
%
""%%
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;>57I (*+'&+I '*!&I ,'I , I %'$I (*+&,I 1I !&,'&I C6449D@I I +++!'&I $+,I '*I
,/'I '-*+I /!, I I 59>64G%!&-,I *#I ,'I & &I (*I +-(('*,I &I +'!$I '&!&@I I
'-,$!&I'I, I+++!'&+I!&$-I&I!&,*'-,!'&IC59I%!&DAII$,-*IC#&'/$I&I!&+! ,AI
%0I 59I %!&DAI (*'$%I +'$.!&I C!&I (!*+F,%+AI 59>64I %!&DAI +#!$$+I ,*!&!&I C59>64I %!&DAI
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!&'*%,!'&I '&I I (!&I % &!+%+I !&I , I !*+,I +++!'&AI '*I .!I '-,I +-!,$I
0*!++I!&I, I+'&I+++!'&AI&I!$!,,I, I*'-(I!&I&*$I/ &I&@II
%
4.2 ASSESSMENTS
I
I(*!%*1I'-,'%I%+-*I'I, I+,-1I/+I, II+$G*('*,I(!&I+-+$I
C$$%1I,I$@I5=<<AI
'$!I,I$@I6455AI'!&!&&I,I$@I644<D@I'&*1I'-,'%+I!&$-I5DI
', *I%+-*+I'I(!&AI+,!&++I&I( 1+!$I-&,!'&AI6DI $, G*$,I)-$!,1I'I$!I&I
'+,I ,!.&++AI 7DI (+1 '$'!$I )-+,!'&&!*+I &I 8DI , I $'$I ++++%&,I 'I &I
CD@I +I /*I ++++I ,I +$!&I &I ,I 7GI &I 56G%'&, I '$$'/G-(I ('!&,+AI (*,I
*'%I , I AI / ! I /+I '&$1I ++++I ,I , I '$$'/G-(I ('!&,+@I &I , I ('+,$I
)-+,!'&&!*+I/I$+'I&)-!*I'-,I+%'#!&I !,+AI$' '$I'&+-%(,!'&AI0*!+AI, I
/'*#I +!,-,!'&I &I %"'*I $!I .&,+I ,I I ++++%&,I ('!&,@I -*, *%'*AI )-+,!'&+I
'-,I%'*( !I *,*!+,!+I/*I(*+&,I,I+$!&AI&I, I(,!&,+I/*I+#I
,'I'%($,I, I**'I-+-$'+#$,$I!&I-+,!'&&!*IC!&,'&I&I'*+%I6447DI,'I
!&,!1I, '+I,I*!+#I'I(*+!+,&,I(!&@I
I '-,'%+I /*I %+-*I ,I +$!&AI &I ,I 7GI &I 56G%'&, I '$$'/G-(I ('!&,+@I
'+,$I)-+,!'&&!*+I/*I-+I,'I'$$,!&I, I'-,'%I,I,I I++++%&,I('!&,@II
%
""%$
%#%%%
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I !&&!+ I .*+!'&I 'I , I I +I $+'I &I '&+!*I .$!AI *$!$I &I
*(*'-!$I C$$%1I ,I $@I 5=<<AI '$!I ,I $@I 6455AI '!&!&&I ,I $@I 644<D@I I I
'&+!+,+I'I, *I!%&+!'&+BI(!&IC9I!,%+DAI+,!&++IC6I!,%+DI&I( 1+!$I-&,!'&!&IC5;I
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$, AI( 1+!$I-&,!'&AI%&,$I $, AI+'!$I-&,!'&AI.!,$!,1AI'!$1I(!&AI&I( 1+!$I
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7DI -+!&I !$1@I *,!!(&,+I /*I $+'I +#I '-,I !&,*G*,!-$*I !&",!'&+I C'*,!+'&I &I
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""
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4.3 STATISTICAL METHODS
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D/)J$%EM $M "%$$M *%M *M -%()*M *(*"M D/)J$%ECM )M &$$*M ,(")>M $M *)M
" ,&&=D 'D #)%'&D " (D *%D 'D =D =D D D "D D &#%&<D "=D
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5.1 CHARACTERISTICS OF STUDY PATIENTS AT BASELINE
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Table 6. Baseline characteristics of the 111 study patients, n (%).
Female
Age, mean (SD)
KL grade of knee osteoarthritis
KL2
KL3
KL4
Knee osteoarthritis
Unilateral
Bilateral
Duration of knee pain symptoms in years, mean (SD)
Educational level
Junior high or less
Senior high/vocational school or more
Work situation
Working
Not working
Marital status
Married or co-habiting
Living alone
Body mass index (kg/m2)
Less than 30
30 or more
Number of comorbidities, mean (SD)
Exercise
Once a week or less
2 times a week or more
Alcohol consumption (units per week)
0−7
8−15
16−23
Smoking habits
Non- or ex-smoker
Sporadic or regular smoker
SD, standard deviation; KL, Kellgren-Lawrence grade0
0
0
0
GP care +
intervention
(n=55)
39 (71)
64.5 (7.3)
GP care
(n=56)
P-value
between
groups
.727
.217
38 (68)
62.8 (7.2)
33 (60)
19 (35)
3 (6)
34 (61)
20 (36)
2 (4)
37 (67)
18 (33)
6.6 (4.5)
39 (70)
17 (30)
8.9 (8.7)
12 (22)
42 (78)
22 (39)
34 (61)
.054
9 (16)
46 (84)
14 (25)
42 (75)
.264
37 (69)
17 (32)
36 (64)
20 (36)
.640
29 (53)
26 (47)
5.3 (2.8)
36 (67)
18 (33)
4.9 (3.6)
15 (27)
40 (73)
17 (32)
36 (68)
.585
46 (92)
4 (8)
0 (0)
49 (91)
3 (6)
2 (4)
.779
49 (89)
6 (11)
50 (91)
5 (9)
.752
.880
.788
.079
.138
.537
Enrollment
Excluded
n=293 (77%)
Reason for exclusion:
WOMAC pain (173)
Arthroplasty (35)
Other pain (29)
No knee pain (12)
Problems with travel
or timetable (11)
Psychiatric illness (7)
Not motivated (7)
Moved (5)
Double mailing (5)
Cognitive impairment (4)
Other surgery of the lower
extremity planned (3)
Dead (2)
Knee X-ray taken in
primary health care
n=6320
Patient’s call to
the study doctors
Recruitment letters
to KL 2–4
n=1389 (22%)
Recruitment letters
n=110
Responses
n=379 (27%)
Responses
n=69 (63%)
Included
n =86 (23%)
Included
n=25 (36%)
Reason for exclusion:
WOMAC pain (36)
No X-ray or KL1 (5)
Psychiatric illness (2)
Age over 75 (1)
WOMAC
RAND-36 (SF-36), 15D
Pain questionnaires
BDI-21, BAI
TSK, PC Scale, PSEQ
LS, SOC, GAC
Use of health services
Use of pain medication
Group lecture
Randomization
n=111
Follow-up
Excluded
n=44 (64%)
Included
n=111 (25%)
Assessment point: baseline
Allocation
Excluded by
phone interview
GP care + CBT intervention:
n=55
Received intervention n=55
Assessment point: 3 months
n=54 (98%)
Lost to 3-month follow-up (1):
No response (1)
TKA (1)
Assessment point: 12 months
n=53 (96%)
Lost to 12-month follow-up (2):
No response (2)
GP care
n=56
Assessment point: 3 months
n=47 (84%)
Lost to 3-month follow-up (10):
Dissatisfied (1), dropped out
No response (8)
Assessment point: 12 months
n = 45 (80%)
Lost to 12-month follow-up (11):
Dead (1), dropped out
Dissatisfied (1), dropped out
No response (8)
TKA (1)
TKA (4), Osteotomy (1)
Analysis
Analyzed:
Mixed models n=55
Follow-up 3/12 months n=54/53
Analyzed:
Mixed models n=56
Follow-up 3/12 months n=47/45
Figure 1. Flow of study patients. CBT, cognitive-behavioural treatment; KL, Kellgren-Lawrence
grade; WOMAC, Western Ontario and McMaster osteoarthritis index; RAND-36, the RAND 36item health survey; 15D, generic 15D instrument; BDI-21, 21-item Beck’s Depression
Inventory; BAI, Beck’s Anxiety Index; TSK, Tampa Scale for Kinesiophobia; PC Scale, Pain
Catastrophizing Scale; PSEQ, Pain Self-Efficacy Questionnaire; LS, Life Satisfaction; SOC, Sense
of Coherence; GAC, global assessment of change; TKA, total knee arthroplasty.
5.2 PSYCHOLOGICAL FACTORS ASSOCIATED WITH PAIN AND
FUNCTION AT BASELINE (ARTICLE II)
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)&C 9C "%&C $$%%"!C !+%%C $(C !C %%"&"!C &)!C C C C C
%"$C!C"!!C&"C&C)"$%&C&$&C!C&C>)"$%&C#!C'$!C&C%&C0C "!&%?C$&!CCCCCCCCC
:#7-8-2;8C"C"&$C%!!&C%%"&"!%C $8C
5.3 EFFECTIVENESS OF THE COGNITIVE-BEHAVIOURAL INTERVENTION
(ARTICLE III)
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$"'#%C "$C !+C "'&" C %'$%C "C #!C "$C '!&"!8C "!C "
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%!!&C $!C )%C &&C !C &C "&"!C )A!C '&A& C %'%C !C
("'$C "C &C !&$(!&"!C $"'#C :$6-8-05;8C C &$!C !C &C %'%9C ")($9C )%C
%!!C!C"&C"C&C$"'#%9C%"C&C *C "C&&CC% $C!C"$C&"%C
)"CC#$&#&C!C&C!&$(!&"!8CC$%'&%C$C#$%!&C!CC48CC
"!C &C #%+""C ($%C #$%!&C !C C 59C C %!!&C $!C
&)!C $"'#%C )%C "'!C !C &C C :$6-8-//;C !C ("'$C "C &C "!&$"C $"'#8C
"!(!&"!C$"'#C" #$%"!%C:&'!&=%C&A&%&9C!!B&!+CA&%&;C"C !C"")A
'#C ('%C $(C !"C %!!&C $!%C &)!C &C $"'#%C !C !+C "C &C "'&" C
($%8CCC#!C%'%C)%C%&+C")$C!C&C!&$(!&"!C$"'#C&C"&C
"")A'#C#"!&%C!C&CC'!&"!C%'%C&C&C%"$&A&$ C"")A'#C#"!&9C'&C
!"C%&&%&+C%!!&C$!%C)$C&&C&C&%C& C#"!&%8C'$&$ "$9C&$C
)$C !"C %!!&C $!%C &)!C &C $"'#%C &C !+C %%%% !&C #"!&C !C &C '%C "C
#!C &"!9C &C !' $C "C "&"$C ##"!& !&%9C #+%"&$#%&C ##"!& !&%9C "$C
%A(C+%C")!C&"C8C
C
C
C
C
C
C
C
C
C
C
C
C
C
C
WOMAC pain
Intervention + GP care (n=55/55)
GP care (n=56/48)
WOMAC function
Intervention + GP care (n=55/55)
GP care (n=56/48)
NPRS average last week
Intervention + GP care (n=54/55)
GP care (n=55/48)
NPRS average 3 months
Intervention + GP care (n=55/55)
GP care (n=56/48)
HRQoL, 15D
Intervention + GP care (n=55/55)
GP care (n=56/48)
RAND-36 Physical Functioning
Intervention + GP care (n=55/55)
GP care (n=56/48)
RAND-36 Role-Physical
Intervention + GP care (n=53/54)
GP care (n=54/48)
RAND-36 Bodily Pain
Intervention + GP care (n=53/55)
GP care (n=54/48)
RAND-36 General Health
Intervention + GP care (n=55/55)
GP care (n=56/48)
RAND-36 Vitality
Intervention + GP care (n=55/55)
GP care (n=55/48)
RAND-36 Social Functioning
Intervention + GP care (n=55/54)
GP care (n=55/48)
Outcome
Pr > F
0.361*
0.170
0.743
0.565*
.068*
0.375
0.396*
0.814
0.064
0.173
0.511*
F value
0.841*
1.911
0.108
0.334*
3.402*
0.796
0.727*
0.056
3.499
1.889
0.436*
Effect of treatment
73.4 (66.4−80.4)
82.5 (76.5−88.5)
62.2 (57.4−67.0)
67.1 (62.3−71.8)
50.8 (46.3−55.3)
56.7 (51.4−62.0)
51.0 (46.4−55.7)
53.6 (48.5−58.6)
35.2 (24.9−45.5)
38.4 (27.7−49.2)
44.4 (38.5−50.3)
49.8 (44.2−55.5)
.82 (.80−.84)
.83 (.80−.86)
6.8 (6.3−7.3)
6.6 (6.1−7.0)
6.6 (6.1−7.0)
6.4 (5.9−6.8)
53.0 (48.1−57.9)
48.4 (43.1−53.7)
57.6 (53.9−61.3)
56.4 (52.9−60.0)
M (95% CI)
Baseline value
75.0 (68.2−81.8)
82.8 (77.6−88.0)
62.7 (57.2−68.2)
67.5 (61.8−73.3)
53.1 (48.6−57.7)
58.2 (52.2−64.1)
57.3 (51.5−63.0)
57.4 (52.0−62.8)
44.4 (34.5−54.4)
44.5 (33.9−55.1)
48.0 (41.5−54.6)
49.4 (43.6−55.2)
.82 (.80−.85)
.85 (.83−.88)
5.2 (4.6−5.8)
5.4 (4.8−6.0)
5.0 (4.3−5.6)
4.9 (4.3−5.5)
36.5 (30.6−42.3)
36.7 (31.0−42.4)
35.6 (30.0−41.1)
39.5 (33.7−45.2)
M (95% CI)
Post-treatment average
†
0.156
‡
0.258‡
0.198‡
0.916‡
0.976‡
0.731‡
0.068†
0.564
0.970
†
0.951†
0.332†
P value
−7.8 (−16.4−0.81)
−4.8 (−12.6−3.1)
−5.0 (−12.3−2.3)
−0.1 (−8.0−7.7)
−0.09 (−14.4−14.3)
−1.4 (−10.2−7.3)
−0.03 (−0.06−0.00)
−0.2 (−1.0−0.6)
0.02 (−0.89−0.93)
−0.3 (−8.3−7.8)
−3.9 (−11.8−4.0)
Estimated difference between
study groups
M (95% CI)
Table 7. Treatment outcomes of pain, physical function, health-related quality of life, and body mass index adjusted for age, gender, and disease
severity (n = number of participant analysed at baseline/number of participants analysed at post-treatment average).
RAND-36 Role-Emotional
0.570
0.452
Intervention + GP care (n=55/53)
68.5 (57.2−79.8)
67.9 (58.1−77.8)
0.456‡
GP care (n=55/48)
75.8 (65.9−85.6)
74.7 (65.3−84.0)
−6.7 (−20.2−6.8)
RAND-36 Emotional Well-Being
4.432
0.038**
‡
Intervention + GP care (n=55/55)
78.1 (74.0−82.3)
75.3 (71.1−79.5)
0.201
GP care (n=55/48)
81.4 (77.8−85.0)
78.5 (73.7−83.3)
−3.2 (−9.5−3.1)
RAND-36 Health Change
0.037
0.849
Intervention + GP care (n=55/55)
40.9 (35.7−46.2)
46.6 (40.6−52.6)
0.948‡
GP care (n=55/48)
45.0 (38.3−51.7)
47.4 (41.5−53.3)
−0.8 (−9.2−7.6)
BMI
0.445*
0.506*
Intervention + GP care (n=55/55)
30.1 (28.5−31.8)
30.0 (28.3−31.6)
0.697†
GP care (n=54/48)
29.9 (28.2−31.6)
29.5 (27.9−31.1)
0.5 (−1.9−2.8)
CI, confidence interval; WOMAC, Western Ontario and McMaster University Osteoarthritis Index; NPRS, numeric pain rating scale; HRQoL, health-related quality of
life; 15D, generic 15D instrument; GAC, global assessment of change; BMI, body mass index.
*Time-by-treatment interaction removed from the mixed model; **Pr<0.05; †Student’s t-test; ‡Mann-Whitney nonparametric test.
Effect of treatment
F value
Pr > F
3.395
0.068
Life Satisfaction (4−20)
Intervention + GP care (n=55/55)
GP care (n=56/48)
Sense of Coherence (3−91)
0.804*
0.372*
Intervention + GP care (n=55/55)
GP care (n=56/48)
Pain Self-Efficacy Questionnaire (0−60)
5.416
0.022**
Intervention + GP care (n=55/55)
GP care (n=56/48)
Tampa Scale of Kinesiophobia (17−68)
1.866
0.175
Intervention + GP care (n=55/55)
GP care (n=56/48)
Pain Catastrophizing Scale (0−52)
0.784*
0.378*
Intervention + GP care (n=55/55)
GP care (n=56/48)
Beck Depression Inventory (0−63)
1.212
0.274
Intervention + GP care (n=55/55)
GP care (n=56/48)
Beck Anxiety Inventory (0−63)
2.641
0.107
Intervention + GP care (n=55/55)
GP care (n=56/48)
CI, confidence interval. * Time-by-treatment interaction removed from
Outcome
59.4 (58.0−60.8)
59.4 (57.9−60.9)
43.1 (40.1−46.2)
46.2 (43.3−49.0)
33.0 (31.0−35.1)
32.8 (29.9−35.7)
15.5 (13.1−18.0)
12.2 (9.7−14.7)
5.8 (4.7−6.8)
5.9 (4.1−7.7)
59.0 (57.5−60.5)
60.9 (59.3−62.4)
44.0 (41.5−46.4)
43.5 (40.6−46.4)
35.0 (32.5−37.4)
33.3 (30.7−36.0)
16.9 (13.8−20.0)
13.5 (10.7−16.2)
6.1 (4.8−7.4)
5.8 (4.5−7.1)
9.0 (7.2−10.8)
8.0 (6.5−9.5)
7.1 (5.7−8.5)
7.1 (5.4−8.8)
the mixed model; **Pr<0.05; †Student’s t-test.
7.9 (7.2−8.6)
7.7 (6.8−8.6)
Post-treatment average
M (95% CI)
7.9 (7.2−8.6)
7.8 (7.1−8.5)
Baseline value
M (95% CI)
P value†
0.406
0.900
0.060
0.891
0.153
0.984
0.754
0.9 (−1.3−3.1)
−0.1 (−2.2−2.0)
3.3 (−0.1−6.8)
0.2 (−3.3−3.7)
−3.01 (−7.2−1.1)
.02 (−2.0−2.1)
0.2 (−1.0−1.3)
Estimated difference between
study groups, M 95% CI
Table 8. Treatment outcomes of psychological variables adjusted for age, gender, and disease severity (n = number of participant analysed at
baseline/number of participants analysed at post-treatment average).
5.4 DETERMINANTS OF PAIN AND FUNCTION IN ONE-YEAR FOLLOW-UP
(ARTICLE IV)
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39 6.2 METHODOLOGICAL CONSIDERATIONS
The major strength of this study was the fact that it was an RCT. Other strengths include the repeated examination of a number of OA-­‐‑related outcomes, the use of radiographic X-­‐‑
ray to confirm the OA diagnosis, and the use of intent-­‐‑to-­‐‑treat. Considering previous CB intervention studies on knee OA pain, there has only been one trial with uncompromising report of radiographic confirmation of the disease: the pilot study by Rini et al. (2015) on Internet-­‐‑based PCST for knee or hip OA patients. From the quasi-­‐‑experimental study by Riddle et al. (2011), however, one can conclude that the patients had to have undisputable OA since they were scheduled for arthroplasty. The other studies, in turn, did not have radiological inclusion criteria or also accepted KL0 (no radiological changes) (Broderick et al. 2014) or KL1 (possible, but not clear, OA changes) (Somers et al. 2012). Furthermore, one can consider that the study sample was representative of ordinary community-­‐‑dwelling knee OA patients, as most of the participants (77%, n=86) were enrolled in the study as a result of a previous referral to a knee X-­‐‑ray by their GPs. Considering the GP care group, arranging attention control for them would have added to the quality of the study. For instance, providing educational lectures to them would have diminished the possibility of the Hawthorne effect (McCarney et al. 2007). The pain level (WOMAC) required to enter this study warrants discussion. The most common reason (47%, n=209) for exclusion of the study was failing to meet this pain criterion. However, as WOMAC pain (VAS ≥40/100 mm) was our primary outcome measure lowering this criterion would have led to a substantial increase in the number of patients needed for the study to obtain sufficient statistical power. In hindsight, however, NPRS would have been a better choice of pain inclusion criterion. Of the study candidates (n=365), a level of ≥4/10 in NPRS regarding average pain during the previous week or past three months was reported by 57% and 66%, respectively, while only 41% fulfilled the WOMAC pain criterion required. Moreover, having NPRS as a pain inclusion criterion would have picked up better those at risk of chronic pain syndrome in the Örebro Musculoskeletal Pain Questionnaire, with a sensitivity of 66% and 73% (≥4/10 in NPRS of average pain during the previous week or past three months) vs. 47% (≥40/100 mm WOMAC) (unpublished data). A central question concerning the methodology of the present RCT is the applicability of Linton’s CB treatment model (Linton and Andersson 2000) to our study population. Linton himself suggests that the model can be used in all musculoskeletal pain disorders (Linton 2005a) in primary care. However, the model was originally developed for spinal pain patients with a high risk of developing chronic pain problems. Thus, the intervention was targeted at patients of working age having only a small number of sick leave days during the previous six months (Linton and Andersson 2000). The mean age of the CB treatment participants was 44 years in the original intervention study (Linton and Andersson 2000). In the present study, the mean age was 63 years with a history of knee pain symptoms for over six years on average. Thus, one might argue that the majority of the study subjects had probably found their own ways of coping with knee OA-­‐‑related disability and recurrent pain. However, one should remember the different nature of knee OA pain compared to spinal pain. Firstly, the natural coarse of pain episodes is quite different between the two: spinal pain typically has an intensive start and diminishes in most cases (60%) in one month (Pengel et al. 2003). The onset of more painful episodes in knee OA is usually more gradual and pain appears to deteriorate slowly, with limited evidence of worsening after 3 years of follow-­‐‑up (van Dijk et al. 2006). With this background, an average history of six years from the onset of knee OA pain symptoms is not necessarily very long, and many of the study patients may actually still be non-­‐‑chronic pain patients. Furthermore, in comparison with the CB intervention studies represented in 40 Table 4 the average time from a knee OA diagnosis was even longer in the studies reporting it (Calfas et al. 1992, Keefe et al. 1996, Riddle et al. 2011) than in the present study. Taking a closer look at the content and session outlines in Linton’s CB model (Linton 2005b) and comparing them with the PCST model (Rini et al. 2015) used in most other CB intervention studies on knee OA patients, one has to admit that there are quite many similarities. Apart from the fact that the PCST usually contains from eight to ten sessions and Linton’s model six, there appears to be little difference between the programmes. Both of the models seem to follow the same core principles: first, the rationale for why CB techniques might help with pain coping; second, systematic training of these techniques (e.g. relaxation, activity pacing, goal setting, cognitive restructuring and problems solving); and third, behavioural rehearsal (role playing of application skills with corrective therapist feedback) in how to apply the techniques in challenging pain-­‐‑related situations. The emphasis of the PCST may be somewhat more on rehearsing the different techniques. In general, over the years, the content of PCST seems to have evolved and been modified in relation to the study group and setting. For instance, the number of sessions has varied from 8 (Riddle et al. 2011, Rini et al. 2015) to 18 (Somers et al. 2012) in different studies, some of the studies have combined in-­‐‑person and telephone-­‐‑based sessions (Riddle et al. 2011, Somers et al. 2012) and the training programme has been delivered individually, with spousal support, in groups and via the Internet. Moreover, the personnel delivering PCST have varied greatly: from a psychologist and nurse working as a team (Keefe et al. 1996, Keefe et al. 1999, Keefe et al. 1990a, Keefe et al. 1990b) or alone (Broderick et al. 2014, Riddle et al. 2011), or a physiotherapist alone (Bryant et al. 2014), to an automated virtual coach (Rini et al. 2015) in an Internet-­‐‑based training programme. In conclusion, PCST as such is not a rigidly defined intervention model, but rather a selection of theoretical principles and techniques and practices for coping skills that can be applied to different settings. With respect to the effectiveness of PCST, positive long-­‐‑term results were reported from the study by Somers et al. (2012) testing a fairly extensive PCST programme (18 sessions) combined with a behavioural weight management programme and the study by Broderick et al. (2014) on patients with knee or hip OA attending 10 individual PCST sessions held by nurse practitioners. These results are not directly comparable with those of the present study, since the one by Somers et al. did not report of the effectiveness of the plain PCST in comparison with SC, and the one by Broderick et al. also included hip OA patients. However, in these studies, the intervention was either very long (one year) or quite intensive (several group sessions per week or individual training). From the findings of therapy interventions among anxiety and mood disorders, it is known that long-­‐‑term psychotherapies result in larger and more sustained changes in personality functioning (Lindfors et al. 2015). That is, the longer and heavier the intervention, the better the results. Thus, the effectiveness of CB interventions among OA patients may depend more on the duration and intensity of the treatment model than on the fine-­‐‑tuning of its contents. Considering the present study, it may well have been that the main reason for the mild effect of the intervention was the fact that six group sessions of CB training were simply not enough. Another point worth consideration is the competence and adherence of the therapists to the CB model. An undisputable asset of the studies applying PCST is that most of them, even the earliest studies, have used audiotapes from the sessions to evaluate treatment integrity and/or to give feedback to the personnel. The vast experience of the researchers in PCST is evident in the most recent studies concerning the training of different health professionals to deliver the intervention (Broderick et al. 2014, Bryant et al. 2014). In the current RCT, the same team comprising a trained psychologist and a physiotherapist both with profound experience in treating musculoskeletal pain patients with CB modalities, delivered the CB programme to all the intervention groups. Hence, their integrity to the programme can be assumed high but no objective evaluation of their adherence to the 41 treatment programme was carried out. Furthermore, therapist competence and therapeutic alliance have been demonstrated to be related to the outcome in cognitive therapy for depression (Trepka et al. 2004). Evaluation of the therapeutic alliance during the CB intervention is another factor that would have given valuable information in the interpretation of the results in the current trial. The learning process in the CB intervention is a key factor regarding its impact and effectiveness. CB techniques, like any other skills, require extensive rehearsing in real life situations. A point of criticism in our study methodology is that Linton’s model does not include any assessments of adherence to the CB practices of pain management after the programme. In hindsight, such measurements would have given us valuable information when interpreting the study results and evaluating the effect of the intervention. During the intervention, however, Linton’s model did incorporate home assignments and their revision in the next group session, as well as the practicing of coping skills during the meetings as well. All in all, the main reason for us to use Linton’s model was practicality: we wanted a standardized and easily accessible model for further use. A model with six sessions and a translated manual could have been quite easily applied to primary care, if the results had suggested it. In spite of the negative results in the present RCT, CB treatment methods have been found useful in the management of chronic pain in general, with some evidence of positive effects being found at six months (Williams et al. 2012). However, it has been suggested that treating all chronic pain patients with the same set of methods may lead to incorrect interpretations regarding treatment efficacy (Bergstrom et al. 2012, Turk 2005). One way of trying to tackle this problem is through identifying patient subgroups and tailoring interventions to their needs. While this approach has been investigated with promising results (Bergstrom et al. 2012, Broderick et al. 2011, Turk 2005), it may not be a very applicable model in real life. The role of psychological determinants in knee OA pain and function is undisputed, and the call for effective interventions in this field remains strong. As the results of plain CB interventions, including the current study, have been low or modest, there is a need for new approaches and innovative RCTs in order to find ways to influence these factors. 6.3 CLINICAL IMPLICATIONS
A six-­‐‑week group-­‐‑based CB programme did not have a significant effect on pain or function in community-­‐‑dwelling knee OA patients. Thus, CB programmes of a similar length and content should not be recommended in health care for this patient group. Both positive psychological determinants (resources) and negatively charged emotions and expectations toward pain are important factors when dealing with knee OA patients. The role of resource factors is highlighted in the long term. The routine assessment of multiple psychological factors in knee OA patients might be useful to identify those patients or sub-­‐‑
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Eeva-Eerika Helminen
Knee Osteoarthritis:
Determinants of Pain and
Function and Effects of a
Group-Based CognitiveBehavioural Intervention
An increasing amount of evidence
has emerged of psychological
factors having an important role
in osteoarthritis patients’ reports
of pain and coping. The aim of this
study was to examine the effect of a
group-based cognitive-behavioural
intervention on knee osteoarthritis
pain patients. The intervention
did not have any effect on pain or
function. However, the significance
of anxiety symptoms as predictors of
pain and functional impairment was
emphasized. Psychological resource
factors predicted better functioning
during the one-year follow-up.
Publications of the University of Eastern Finland
Dissertations in Health Sciences
isbn 978-952-61-1846-8