Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2013

Open Access 01-12-2013 | Study protocol

Effectiveness of a cognitive-behavioral group intervention for knee osteoarthritis pain: protocol of a randomized controlled trial

Authors: Eeva-Eerika Helminen, Sanna H Sinikallio, Anna L Valjakka, Rauni H Väisänen-Rouvali, Jari P Arokoski

Published in: BMC Musculoskeletal Disorders | Issue 1/2013

Login to get access

Abstract

Background

Knee osteoarthritis is the most common type of arthritis, with pain being its most common symptom. Little is known about the psychological aspects of knee osteoarthritis pain. There is an emerging consensus among osteoarthritis specialists about the importance of addressing not only biological but also psychosocial factors in the assessment and treatment of osteoarthritis. As few studies have evaluated the effect of psychological interventions on knee osteoarthritis pain, good quality randomized controlled trials are needed to determine their effectiveness.

Methods/Design

We intend to conduct a 6-week single-blinded randomized controlled trial with a 12-month follow-up. Altogether, 108 patients aged from 35 to 75 years with clinical symptoms and radiographic grading (KL 2–4) of knee osteoarthritis will be included. The clinical inclusion criteria are pain within the last year in or around the knee occurring on most days for at least one month, and knee pain of ≥40 mm on a 100-mm visual analogue scale in the WOMAC pain subscale for one week prior to study entry. Patients with any severe psychiatric disorder, other back or lower limb pain symptoms more aggravating than knee pain, or previous or planned lower extremity joint surgery will be excluded. The patients will be randomly assigned to a combined GP care and cognitive-behavioral intervention group (n = 54) or to a GP care control group (n = 54). The cognitive-behavioral intervention will consist of 6 weekly group sessions supervised by a psychologist and a physiotherapist experienced in the treatment of pain. The main goals of the intervention are to reduce maladaptive pain coping and to increase the self-management of pain and disability. The follow-up-points will be arranged at 3 and 12 months. The primary outcome measure will be the WOMAC pain subscale. Secondary outcome measures will include self-reports of pain and physical function, a health related quality of life questionnaire, and various psychological questionnaires. Personnel responsible of the data analysis will be blinded.

Discussion

This study addresses the current topic of non-pharmacological conservative treatment of knee OA-related pain. We anticipate that these results will provide important new insights to the current care recommendations.

Trial registration

Current Controlled Trials ISRCTN64794760
Appendix
Available only for authorised users
Literature
1.
Arden N, Nevitt MC: Osteoarthritis: Epidemiology. Best Pract Res Clin Rheumatol. 2006, 20 (1): 3-25.CrossRefPubMed
2.
Bitton R: The economic burden of osteoarthritis. Am J Manag Care. 2009, 15 (8 Suppl): S230-S235.PubMed
3.
4.
Somers TJ, Keefe FJ, Pells JJ, Dixon KE, Waters SJ, Riordan PA, Blumenthal JA, McKee DC, LaCaille L, Tucker JM, Schmitt D, Caldwell DS, Kraus VB, Sims EL, Shelby RA, Rice JR: Pain catastrophizing and pain-related fear in osteoarthritis patients: relationships to pain and disability. J Pain Symptom Manage. 2009, 37 (5): 863-872.CrossRefPubMed
5.
He Y, Zhang M, Lin EH, Bruffaerts R, Posada-Villa J, Angermeyer MC, Levinson D, de Girolamo G, Uda H, Mneimneh Z, Benjet C, de Graaf R, Scott KM, Gureje O, Seedat S, Haro JM, Bromet EJ, Alonso J, von Korff M, Kessler R: Mental disorders among persons with arthritis: results from the World Mental Health Surveys. Psychol Med. 2008, 38 (11): 1639-1650.CrossRefPubMedPubMedCentral
6.
7.
Turk DC, Meichenbaum D, Genest M: Pain and Behavioral Medicine: A Cognitive-Behavioral Perspective. 1983, New York: Guilford
8.
9.
Vlaeyen JW, Linton SJ: Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000, 85 (3): 317-332.CrossRefPubMed
10.
Arnstein P, Caudill M, Mandle CL, Norris A, Beasley R: Self efficacy as a mediator of the relationship between pain intensity, disability and depression in chronic pain patients. Pain. 1999, 80 (3): 483-491.CrossRefPubMed
11.
Litt MD: Self-efficacy and perceived control: cognitive mediators of pain tolerance. J Pers Soc Psychol. 1988, 54 (1): 149-160.CrossRefPubMed
12.
McCracken LM, Eccleston C: Coping or acceptance: what to do about chronic pain?. Pain. 2003, 105 (1–2): 197-204.CrossRefPubMed
13.
Linton SJ, Nicholas MK, MacDonald S, Boersma K, Bergbom S, Maher C, Refshauge K: The role of depression and catastrophizing in musculoskeletal pain. Eur J Pain. 2011, 15 (4): 416-422.CrossRefPubMed
14.
Benyon K, Hill S, Zadurian N, Mallen C: Coping strategies and self-efficacy as predictors of outcome in osteoarthritis: a systematic review. Musculoskeletal Care. 2010, 8 (4): 224-236.CrossRefPubMed
15.
Creamer P, Lethbridge-Cejku M, Hochberg MC: Factors associated with functional impairment in symptomatic knee osteoarthritis. Rheumatology (Oxford). 2000, 39 (5): 490-496.CrossRef
16.
Turk DC, Wilson HD: Fear of pain as a prognostic factor in chronic pain: conceptual models, assessment, and treatment implications. Curr Pain Headache Rep. 2010, 14 (2): 88-95.CrossRefPubMedPubMedCentral
17.
Calfas KJ, Kaplan RM, Ingram RE: One-year evaluation of cognitive-behavioral intervention in osteoarthritis. Arthritis Care Res. 1992, 5 (4): 202-209.CrossRefPubMed
18.
Riddle DL, Keefe FJ, Nay WT, McKee D, Attarian DE, Jensen MP: Pain coping skills training for patients with elevated pain catastrophizing who are scheduled for knee arthroplasty: a quasi-experimental study. Arch Phys Med Rehabil. 2011, 92 (6): 859-865.CrossRefPubMedPubMedCentral
19.
Somers TJ, Blumenthal JA, Guilak F, Kraus VB, Schmitt DO, Babyak MA, Craighead LW, Caldwell DS, Rice JR, McKee DC, Shelby RA, Campbell LC, Pells JJ, Sims EL, Queen R, Carson JW, Connelly M, Dixon KE, Lacaille LJ, Huebner JL, Rejeski WJ, Keefe FJ: Pain coping skills training and lifestyle behavioral weight management in patients with knee osteoarthritis: A randomized controlled study. Pain. 2012, 153 (6): 1199-1209.CrossRefPubMedPubMedCentral
20.
Hurley MV, Walsh NE, Mitchell H, Nicholas J, Patel A: Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial. Arthritis Care Res (Hoboken). 2012, 64 (2): 238-247.CrossRef
21.
Keefe FJ, Blumenthal J, Baucom D, Affleck G, Waugh R, Caldwell DS, Beaupre P, Kashikar-Zuck S, Wright K, Egert J, Lefebvre J: Effects of spouse-assisted coping skills training and exercise training in patients with osteoarthritic knee pain: a randomized controlled study. Pain. 2004, 110 (3): 539-549.CrossRefPubMed
22.
Linton SJ: Understanding pain for better clinical practice. Session manual for therapists. 2005, New York: Edinburgh: Elsevier, 151-166.
23.
Linton SJ, Andersson T: Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain. Spine (Phila Pa 1976). 2000, 25 (21): 2825-2831. discussion 2824CrossRef
24.
Linton SJ, Ryberg M: A cognitive-behavioral group intervention as prevention for persistent neck and back pain in a non-patient population: a randomized controlled trial. Pain. 2001, 90 (1–2): 83-90.CrossRefPubMed
25.
Linton SJ, Boersma K, Jansson M, Svard L, Botvalde M: The effects of cognitive-behavioral and physical therapy preventive interventions on pain-related sick leave: a randomized controlled trial. Clin J Pain. 2005, 21 (2): 109-119.CrossRefPubMed
26.
Working group appointed by the Finnish Medical Society Duodecim and the Finnish Orthopaedic Association: Knee and hip osteoarthritis: Current Care guideline.http://​www.​kaypahoito.​fi,
27.
28.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW: Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988, 15 (12): 1833-1840.PubMed
29.
McConnell S, Kolopack P, Davis AM: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001, 45 (5): 453-461.CrossRefPubMed
30.
Soininen JV, Paavolainen PO, Grönblad MA, Kääpa EH: Validation study of a Finnish version of the Western Ontario and McMasters University osteoarthritis index. Hip Int. 2008, 18 (2): 108-111.PubMed
31.
Koli J, Multanen J, Häkkinen A, Kiviranta I, Kujala U, Heinonen A: Reliability of the Finnish version of WOMAC and KOOS forms for knee osteoarhtritis [abstract]. Physiotherapy. 2011, 97 (Supp S1): D203-D204.
32.
Kellgren JH, Jeffrey MR, Ball J: The epidemiology of chronic rheumatism. Atlas of standard radiographs of arthritis. 1963, Philadelphia: FA Davis
33.
Schiphof D, Boers M, Bierma-Zeinstra SM: Differences in descriptions of Kellgren and Lawrence grades of knee osteoarthritis. Ann Rheum Dis. 2008, 67 (7): 1034-1036.CrossRefPubMed
34.
Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4: 561-571.CrossRefPubMed
35.
Raitasalo R: Depression and its Association With The Need For Psychotherapy [in Finnish]. 1977, Helsinki, Finland: The Social Insurance Institute of Finland publications, A 13
36.
Sinikallio S, Aalto T, Airaksinen O, Lehto SM, Kroger H, Viinamäki H: Depression is associated with a poorer outcome of lumbar spinal stenosis surgery: a two-year prospective follow-up study. Spine (Phila Pa 1976). 2011, 36 (8): 677-682.CrossRef
37.
Aalto AM, Elovainio M, Kivimäki M, Uutela A, Pirkola S: The Beck Depression Inventory and General Health Questionnaire as measures of depression in the general population: a validation study using the Composite International Diagnostic Interview as the gold standard. Psychiatry Res. 2012, 197 (1–2): 163-171.CrossRefPubMed
38.
Beck AT, Epstein N, Brown G, Steer RA: An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988, 56 (6): 893-897.CrossRefPubMed
39.
Weizmann-Henelius G, Viemero V, Eronen M: Psychopathy in violent female offenders in Finland. Psychopathology. 2004, 37 (5): 213-221.CrossRefPubMed
40.
Antonovsky A: The structure and properties of the sense of coherence scale. Soc Sci Med. 1993, 36 (6): 725-733.CrossRefPubMed
41.
Bowman BJ: Cross-cultural validation of Antonovsky's Sense Of Coherence Scale. J Clin Psychol. 1996, 52 (5): 547-549.CrossRefPubMed
42.
Flannery RB, Perry JC, Penk WE, Flannery GJ: Validating Antonovsky's Sense of Coherence Scale. J Clin Psychol. 1994, 50 (4): 575-577.CrossRefPubMed
43.
Nilsson B, Holmgren L, Westman G: Sense of coherence in different stages of health and disease in northern Sweden–gender and psychosocial differences. Scand J Prim Health Care. 2000, 18 (1): 14-20.CrossRefPubMed
44.
Kivimäki M, Feldt T, Vahtera J, Nurmi JE: Sense of coherence and health: evidence from two cross-lagged longitudinal samples. Soc Sci Med. 2000, 50 (4): 583-597.CrossRefPubMed
45.
Sinikallio S, Lehto SM, Aalto T, Airaksinen O, Viinamäki H: Low sense of coherence interferes with lumbar spinal stenosis patients' postoperative recovery: a prospective one-year follow-up study. J Health Psychol. 2011, 16 (5): 783-793.CrossRefPubMed
46.
Feldt T, Lintula H, Suominen S, Koskenvuo M, Vahtera J, Kivimäki M: Structural validity and temporal stability of the 13-item sense of coherence scale: prospective evidence from the population-based HeSSup study. Qual Life Res. 2007, 16 (3): 483-493.CrossRefPubMed
47.
Rosenstiel AK, Keefe FJ: The use of coping strategies in chronic low back pain patients: relationship to patient characteristics and current adjustment. Pain. 1983, 17 (1): 33-44.CrossRefPubMed
48.
Sullivan MJLL: The Pain Catastrophizing Scale: Development and Validation. Psychol Assess. 1995, 7 (4): 524-532.CrossRef
49.
Lame IE, Peters ML, Kessels AG, Van Kleef M, Patijn J: Test–retest stability of the Pain Catastrophizing Scale and the Tampa Scale for Kinesiophobia in chronic pain over a longer period of time. J Health Psychol. 2008, 13 (6): 820-826.CrossRefPubMed
50.
Koho P, Aho S, Watson P, Hurri H: Assessment of chronic pain behaviour: reliability of the method and its relationship with perceived disability, physical impairment and function. J Rehabil Med. 2001, 33 (3): 128-132.CrossRefPubMed
51.
Nicholas MK: The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007, 11 (2): 153-163.CrossRefPubMed
52.
Kaivanto KK, Estlander A, Moneta GM, Vanharanta H: Isokinetic performance in low back pain patients: The predictive power of the Self-Efficacy Scale. J Occup Rehabil. 1995, 5 (2): 19-33.CrossRef
53.
Koivumaa-Honkanen H, Honkanen R, Antikainen R, Hintikka J, Laukkanen E, Honkalampi K, Viinamäki H: Self-reported life satisfaction and recovery from depression in a 1-year prospective study. Acta Psychiatr Scand. 2001, 103 (1): 38-44.CrossRefPubMed
54.
Allardt E: About dimension of welfare: an explanatory analysis of the comparative Scandinavian survey. 1973, Finland: Research Group of Comparative Sociology, University of Helsinki
55.
Sinikallio S, Koivumaa-Honkanen H, Aalto T, Airaksinen O, Lehto SM, Viinamäki H: Life dissatisfaction in the pre-operative and early recovery phase predicts low functional ability and coping among post-operative patients with lumbar spinal stenosis: a 2-year prospective study. Disabil Rehabil. 2011, 33 (7): 599-604.CrossRefPubMed
56.
Sherbourne CD, Ware JE: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992, 30 (6): 473-483.CrossRefPubMed
57.
Aalto A, Aro AR, Teperi J: RAND-36 as an indicator of health related quatlity of life: reliability and reference values in the Finnish population [in Finnish]. 1999, Helsinki: STAKES
58.
Räsänen P, Paavolainen P, Sintonen H, Koivisto AM, Blom M, Ryynänen OP, Roine RP: Effectiveness of hip or knee replacement surgery in terms of quality-adjusted life years and costs. Acta Orthop. 2007, 78 (1): 108-115.CrossRefPubMed
59.
Linton SJ, Boersma K: Early identification of patients at risk of developing a persistent back problem: the predictive validity of the Örebro Musculoskeletal Pain Questionnaire. Clin J Pain. 2003, 19 (2): 80-86.CrossRefPubMed
60.
Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M: Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005, 64 (1): 29-33.CrossRefPubMed
61.
Liikavainio T, Lyytinen T, Tyrväinen E, Sipilä S, Arokoski JP: Physical function and properties of quadriceps femoris muscle in men with knee osteoarthritis. Arch Phys Med Rehabil. 2008, 89 (11): 2185-2194.CrossRefPubMed
62.
Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M: OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthr Cartil. 2004, 12 (5): 389-399.CrossRefPubMed
63.
Campbell MJ, Julious SA, Altman DG: Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ. 1995, 311 (7013): 1145-1148.CrossRefPubMedPubMedCentral
64.
Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P: American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012, 64 (4): 455-474.CrossRef
65.
Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P: OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthr Cartil. 2010, 18 (4): 476-499.CrossRefPubMed
66.
Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P: OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthr Cartil. 2007, 15 (9): 981-1000.CrossRefPubMed
67.
van Heuvelen MJ, Hochstenbach JB, Brouwer WH, de Greef MH, Zijlstra GA, van Jaarsveld E, Kempen GI, van Sonderen E, Ormel J, Mulder T: Differences between participants and non-participants in an RCT on physical activity and psychological interventions for older persons. Aging Clin Exp Res. 2005, 17 (3): 236-245.CrossRefPubMed
68.
Franke RHKJ: The Hawthorne experiments: First statistical interpretation. Am Sociol Rev. 1978, 43: 623-643.CrossRef
69.
Braunholtz DA, Edwards SJ, Lilford RJ: Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect". J Clin Epidemiol. 2001, 54 (3): 217-224.CrossRefPubMed
70.
Peppercorn JM, Weeks JC, Cook EF, Joffe S: Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet. 2004, 363 (9405): 263-270.CrossRefPubMed
71.
Mazzuca SA, Brandt KD, Buckwalter KA, Lane KA, Katz BP: Field test of the reproducibility of the semiflexed metatarsophalangeal view in repeated radiographic examinations of subjects with osteoarthritis of the knee. Arthritis Rheum. 2002, 46 (1): 109-113.CrossRefPubMed
72.
Niinimäki T, Ojala R, Niinimäki J, Leppilahti J: The standing fixed flexion view detects narrowing of the joint space better than the standing extended view in patients with moderate osteoarthritis of the knee. Acta Orthop. 2010, 81 (3): 344-346.CrossRefPubMedPubMedCentral
73.
Sun Y, Gunther KP, Brenner H: Reliability of radiographic grading of osteoarthritis of the hip and knee. Scand J Rheumatol. 1997, 26 (3): 155-165.CrossRefPubMed
74.
Gunther KP, Sun Y: Reliability of radiographic assessment in hip and knee osteoarthritis. Osteoarthr Cartil. 1999, 7 (2): 239-246.CrossRefPubMed
75.
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M: Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986, 29 (8): 1039-1049.CrossRefPubMed
Metadata
Title
Effectiveness of a cognitive-behavioral group intervention for knee osteoarthritis pain: protocol of a randomized controlled trial
Authors
Eeva-Eerika Helminen
Sanna H Sinikallio
Anna L Valjakka
Rauni H Väisänen-Rouvali
Jari P Arokoski
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2013
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-14-46

Other articles of this Issue 1/2013

BMC Musculoskeletal Disorders 1/2013 Go to the issue

Research article

Long-term stability of angle-stable versus conventional locked intramedullary nails in distal tibia fractures

Research article

Profile of sexuality in Moroccan chronic low back pain patients

Research article

A systematic review of measures of shoulder pain and functioning using the International classification of functioning, disability and health (ICF)

Study protocol

Effect of pre-operative neuromuscular training on functional outcome after total knee replacement: a randomized-controlled trial

Study protocol

Protocol for determining the diagnostic validity of physical examination maneuvers for shoulder pathology

Research article

Measures and procedures utilized to determine the added value of microprocessor-controlled prosthetic knee joints: a systematic review