A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol

Kim L Bennell, Yasmin Ahamed, Christina Bryant, Gwendolen Jull, Michael A Hunt, Justin Kenardy, Andrew Forbes, Anthony Harris, Michael Nicholas, Ben Metcalf, Thorlene Egerton, Francis J Keefe, Kim L Bennell, Yasmin Ahamed, Christina Bryant, Gwendolen Jull, Michael A Hunt, Justin Kenardy, Andrew Forbes, Anthony Harris, Michael Nicholas, Ben Metcalf, Thorlene Egerton, Francis J Keefe

Abstract

Background: Knee osteoarthritis (OA) is a prevalent chronic musculoskeletal condition with no cure. Pain is the primary symptom and results from a complex interaction between structural changes, physical impairments and psychological factors. Much evidence supports the use of strengthening exercises to improve pain and physical function in this patient population. There is also a growing body of research examining the effects of psychologist-delivered pain coping skills training (PCST) particularly in other chronic pain conditions. Though typically provided separately, there are symptom, resource and personnel advantages of exercise and PCST being delivered together by a single healthcare professional. Physiotherapists are a logical choice to be trained to deliver a PCST intervention as they already have expertise in administering exercise for knee OA and are cognisant of the need for a biopsychosocial approach to management. No studies to date have examined the effects of an integrated exercise and PCST program delivered solely by physiotherapists in this population. The primary aim of this multisite randomised controlled trial is to investigate whether an integrated 12-week PCST and exercise treatment program delivered by physiotherapists is more efficacious than either program alone in treating pain and physical function in individuals with knee OA.

Methods/design: This will be an assessor-blinded, 3-arm randomised controlled trial of a 12-week intervention involving 10 physiotherapy visits together with home practice. Participants with symptomatic and radiographic knee OA will be recruited from the community in two cities in Australia and randomized into one of three groups: exercise alone, PCST alone, or integrated PCST and exercise. Randomisation will be stratified by city (Melbourne or Brisbane) and gender. Primary outcomes are overall average pain in the past week measured by a Visual Analogue Scale and physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes include global rating of change, muscle strength, functional performance, physical activity levels, health related quality of life and psychological factors. Measurements will be taken at baseline and immediately following the intervention (12 weeks) as well as at 32 weeks and 52 weeks to examine maintenance of any intervention effects. Specific assessment of adherence to the treatment program will also be made at weeks 22 and 42. Relative cost-effectiveness will be determined from health service usage and outcome data.

Discussion: The findings from this randomised controlled trial will provide evidence for the efficacy of an integrated PCST and exercise program delivered by physiotherapists in the management of painful and functionally limiting knee OA compared to either program alone.

Trial registration: Australian New Zealand Clinical Trials Registry reference number: ACTRN12610000533099.

Figures

Figure 1
Figure 1
Diagram of study protocol.

References

    1. Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011;377:2115–2126. doi: 10.1016/S0140-6736(11)60243-2.
    1. Rosemann T, Laux G, Szecsenyi J. Osteoarthritis: quality of life, comorbidities, medication and health service utilization assessed in a large sample of primary care patients. J Orthop Surg Res. 2007;2:12. doi: 10.1186/1749-799X-2-12.
    1. Somers TJ, Keefe FJ, Godiwala N, Hoyler GH. Psychosocial factors and the pain experience of osteoarthritis patients: new findings and new directions. Curr Opin Rheumatol. 2009;21:501–506. doi: 10.1097/BOR.0b013e32832ed704.
    1. Access Economics. Painful Realities: The economic impact of arthritis in Australia. Access Economics Pty, Ltd, Canberra; 2007. pp. 1–90.
    1. Ettinger WH, Davis MA, Neuhaus JM, Mallon KP. Long-term physical functioning in persons with knee osteoarthritis from NHANES. I: Effects of comorbid medical conditions. J Clin Epidemiol. 1994;47:809–815.
    1. Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005;365:965–973. doi: 10.1016/S0140-6736(05)71086-2.
    1. Davis MA, Ettinger WH, Neuhaus JM, Mallon KP. Knee osteoarthritis and physical functioning: evidence from the NHANES I Epidemiologic Followup Study. J Rheumatol. 1991;18:591–598.
    1. Sayre EC, Li LC, Kopec JA, Esdaile JM, Bar S, Cibere J. The effect of disease site (knee, hip, hand, foot, lower back or neck) on employment reduction due to osteoarthritis. PLoS One. 2010;5:e10470. doi: 10.1371/journal.pone.0010470.
    1. Creamer P, Hochberg MC. The relationship between psychosocial variables and pain reporting in osteoarthritis of the knee. Arthritis Care Res. 1998;11:60–65. doi: 10.1002/art.1790110110.
    1. Sharma L, Cahue S, Song J, Hayes K, Pai YC, Dunlop D. Physical functioning over three years in knee osteoarthritis: role of psychosocial, local mechanical, and neuromuscular factors. Arthritis Rheum. 2003;48:3359–3370. doi: 10.1002/art.11420.
    1. Dieppe PA. Relationship between symptoms and structural change in osteoarthritis: what are the important targets for therapy? J Rheumatol. 2005;32:1147–1149.
    1. Eitzen I, Holm I, Risberg MA. Preoperative quadriceps strength is a significant predictor of knee function two years after anterior cruciate ligament reconstruction. Br J Sports Med. 2009;43:371–376. doi: 10.1136/bjsm.2008.057059.
    1. 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;37:863–872. doi: 10.1016/j.jpainsymman.2008.05.009.
    1. van Baar ME, Dekker J, Lemmens J, Oostendorp RA, Bijlsma J. Pain and disability in patients with osteoarthritis of hip or knee: the relationship with articular, kinesiological and psychological characteristics. J Rheumatol. 1998;25:125–133.
    1. Smith BW, Zautra AJ. The effects of anxiety and depression on weekly pain in women with arthritis. Pain. 2008;138:354–361. doi: 10.1016/j.pain.2008.01.008.
    1. Rosemann T, Laux G, Szecenyi J, Wensing M, Grol R. Pain and osteoarthritis in primary care: factors associated with pain perception in a sample of 1,021 patients. Pain Med. 2008;9:903–910. doi: 10.1111/j.1526-4637.2008.00498.x.
    1. Sale JE, Gignac M, Hawker G. The relationship between disease symptoms, life events, coping and treatment, and depression among older adults with osteoarthritis. J Rheumatol. 2008;35:335–342.
    1. Roddy E, Zhang W, Doherty M, Arden N, Barlow J, Birrell F, Carr A, Chakravarty K, Dickson J, Hay E, Hosie G, Hurley M, Jordan K, McCarthy C, McMurdo M, Mockett S, O'Reilly S, Peat G, Pendleton A, Richards S. Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee- the MOVE consensus. Rheumatology. 2005;44:67–73. doi: 10.1093/rheumatology/keh399.
    1. Zhang W, Moskowitz R, Nuki G, Abramson S, Altman R, Arden N, Bierma-Zeinstra S, Brandt K, Croft P, Doherty M, Dougados M, Hochberg M, Hunter D, Kwoh K, Lohmander L, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis and Cartilage. 2008;16:137–162. doi: 10.1016/j.joca.2007.12.013.
    1. National Institute of Health and Clinical Excellence (NICE) Guidelines. The care and management of osteoarthritis in adults 2008 National Institute of Health and Clinical Excellence, London; pp. 1–25.
    1. Fransen M, McConnell S. Land-based exercise for osteoarthritis of the knee: a metaanalysis of randomized controlled trials. J Rheumatol. 2009;36(6):1109–1117. doi: 10.3899/jrheum.090058.
    1. Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008;59:1488–1494. doi: 10.1002/art.24118.
    1. Woodard CM, Berry MJ. Enhancing adherence to prescribed exercise: structured behavioral interventions in clinical exercise programs. J Cardiopulm Rehabil. 2001;21:201–209. doi: 10.1097/00008483-200107000-00002.
    1. 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;110:539–549. doi: 10.1016/j.pain.2004.03.022.
    1. Schilke JM, Johnson GO, Housh TJ, O'Dell JR. Effects of muscle-strength training on the functional status of patients with osteoarthritis of the knee joint. Nurs Res. 1996;45:68–72. doi: 10.1097/00006199-199603000-00002.
    1. Thomas KS, Muir KR, Doherty M, Jones AC, O'Reilly SC, Bassey EJ. Home based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial. BMJ. 2002;325:752. doi: 10.1136/bmj.325.7367.752.
    1. O'Reilly SC, Muir KR, Doherty M. Effectiveness of home exercise on pain and disability from osteoarthritis of the knee: a randomised controlled trial. Ann Rheum Dis. 1999;58:15–19. doi: 10.1136/ard.58.1.15.
    1. Focht BC. Effectiveness of exercise interventions in reducing pain symptoms among older adults with knee osteoarthritis: a review. J Aging Phys Act. 2006;14:212–235.
    1. Smeets RJ, Vlaeyen JW, Kester AD, Knottnerus JA. Reduction of pain catastrophizing mediates the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. J Pain. 2006;7:261–271. doi: 10.1016/j.jpain.2005.10.011.
    1. van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H. et al.Tailored cognitive-behavioral therapy and exercise training for high-risk patients with fibromyalgia. Arth Care Research. 2010;62:1377–1385. doi: 10.1002/acr.20268.
    1. Scully D, Kremer J, Meade MM, Graham R, Dudgeon K. Physical exercise and psychological well being: a critical review. Br J Sports Med. 1998;32:111–120. doi: 10.1136/bjsm.32.2.111.
    1. Korstjens I, May AM, van Weert E, Mesters I, Tan F, Ros WJ, Hoekstra-Weebers JE, van der Schans CP, van den Borne B. Quality of life after self-management cancer rehabilitation: a randomized controlled trial comparing physical and cognitive-behavioral training versus physical training. Psychosom Med. 2008;70:422–429. doi: 10.1097/PSY.0b013e31816e038f.
    1. May AM, Van Weert E, Korstjens I, Hoekstra-Weebers JE, Van Der Schans CP, Zonderland ML, Mesters I, Van Den Borne B, Ros WD. Improved physical fitness of cancer survivors: a randomised controlled trial comparing physical training with physical and cognitive-behavioural training. Acta Oncol. 2008;47:825–834. doi: 10.1080/02841860701666063.
    1. Keefe FJ, Caldwell DS, Baucom D, Salley A, Robinson E, Timmons K, Beaupre P, Weisberg J, Helms M. Spouse-assisted coping skills training in the management of knee pain in osteoarthritis: long-term followup results. Arthritis Care Res. 1999;12:101–111. doi: 10.1002/1529-0131(199904)12:2<101::AID-ART5>;2-9.
    1. Keefe FJ, Caldwell DS, Williams D, Gil K, Mitchell D, Robertson C. Pain coping skills in the management of osteoarthritis knee pain: A comparative study. Behavior Therapy. 1990;21:49–62. doi: 10.1016/S0005-7894(05)80188-1.
    1. Turk DC. Biopsychosocial perspective on chronic pain. Guilford Press, New York; 1996.
    1. Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Patel A, Williamson E, Jones RH, Dieppe PA, Reeves BC. Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial. Arthritis Rheum. 2007;57:1211–1219. doi: 10.1002/art.22995.
    1. Pengel LH, Refshauge KM, Maher CG, Nicholas MK, Herbert RD, McNair P. Physiotherapist-directed exercise, advice, or both for subacute low back pain: a randomized trial. Ann Intern Med. 2007;146:787–796.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.
    1. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M. et al.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;29:1039–1049. doi: 10.1002/art.1780290816.
    1. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16:494–502. doi: 10.1136/ard.16.4.494.
    1. Fransen M, McConnell S, Bell M. Exercise for osteoarthritis of the hip or knee. Cochrane Database Syst Rev. 2003. p. CD004286.
    1. Day ML, McGuigan MR, Brice G, Foster C. Monitoring work intensities during resistance training using a session RPE scale. J Strength Cond Res. 2004;18:358–358.
    1. Bellamy N. Osteoarthritis clinical trials: candidate variables and clinimetric properties. J Rheumatol. 1997;24:768–778.
    1. 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;45:453–461. doi: 10.1002/1529-0131(200110)45:5<453::AID-ART365>;2-W.
    1. ten Klooster PM, Drossaers-Bakker KW, Taal E, van de Laar MA. Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient's perspective. Pain. 2006;121:151–157. doi: 10.1016/j.pain.2005.12.021.
    1. Pua YH, Wrigley TV, Cowan SM, Bennell KL. Intrarater test-retest reliability of hip range of motion and hip muscle strength measurements in persons with hip osteoarthritis. Arch Phys Med Rehabil. 2008;89:1146–1154. doi: 10.1016/j.apmr.2007.10.028.
    1. Newcomer KL, Krug HE, Mahowald ML. Validity and reliability of the timed-stands test for patients with rheumatoid arthritis and other chronic diseases. J Rheumatol. 1993;20:21–27.
    1. Dunlop DD, Semanik P, Song J, Sharma L, Nevitt M, Jackson R, Mysiw J, Chang RW. Moving to maintain function in knee osteoarthritis: evidence from the osteoarthritis initiative. Arch Phys Med Rehabil. 2010;91:714–721. doi: 10.1016/j.apmr.2010.01.015.
    1. Hill KD, Bernhardt J, McGann AM, Maltese D, Berkovits D. A new test of dynamic standing balance for stroke patients: reliability, validity and comparison with healthy elderly. Physiotherapy Canada. 1996;48:257–262. doi: 10.3138/ptc.48.4.257.
    1. Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–148.
    1. Martin KA, Rejeski WJ, Miller ME, James MK, Ettinger WH Jr, Messier SP. Validation of the PASE in older adults with knee pain and physical disability. Med Sci Sports Exerc. 1999;31:627–633. doi: 10.1097/00005768-199905000-00001.
    1. Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34:1–8. doi: 10.2165/00007256-200434010-00001.
    1. Richardson J, Peacock S, Iezzi A, Day NA, Hawthorne G. The Assessment of Quality of Life (AQoL) II Instrument Melbourne. Monash University; 2007.
    1. Meenan RF, Mason JH, Anderson JJ, Guccione AA, Kazis LE. AIMS2. The content and properties of a revised and expanded Arthritis Impact Measurement Scales Health Status Questionnaire. Arthritis Rheum. 1992;35:1–10. doi: 10.1002/art.1780350102.
    1. Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32:37–44. doi: 10.1002/anr.1780320107.
    1. Porter LS, Keefe FJ, Wellington C, De Williams A. Pain communication in the context of osteoarthritis: patient and partner self-efficacy for pain communication and holding back from discussion of pain and arthritis-related concerns. Clin J Pain. 2008;24:662–668. doi: 10.1097/AJP.0b013e31816ed964.
    1. Tonkin L. The pain self-efficacy questionnaire - Commentary. Australian Journal of Physiotherapy. 2008;54:77–77. doi: 10.1016/S0004-9514(08)70073-4.
    1. Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007;11:153–163. doi: 10.1016/j.ejpain.2005.12.008.
    1. Osman A, Barrios FX, Gutierrez PM, Kopper BA, Merrifield T, Grittmann L. The Pain Catastrophizing Scale: further psychometric evaluation with adult samples. J Behav Med. 2000;23(4):351–365. doi: 10.1023/A:1005548801037.
    1. Rosenstiel AK, Keefe FJ. The Use of Coping Strategies in Chronic Low-Back-Pain Patients - Relationship to Patient Characteristics and Current Adjustment. Pain. 1983;17:33–44. doi: 10.1016/0304-3959(83)90125-2.
    1. Harland NJ, Georgieff K. Development of the coping strategies questionnaire 24, a clinically utilitarian version of the coping strategies questionnaire. Rehabilitation Psychology. 2003;48:296–300.
    1. Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales (2nd Ed) Psychology Foundation, Sydney, Australia; 1995.
    1. Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005;44:227–239. doi: 10.1348/014466505X29657.
    1. Snell WE. Development of the emotional self-disclosure scale. Sex Roles. 1988;18:59–67. doi: 10.1007/BF00288017.
    1. Pistrang N, Barker C. The partner relationship in psychological response to breast cancer. Soc Sci Med. 1995;40:789–797. doi: 10.1016/0277-9536(94)00136-H.
    1. Figueiredo MI, Fries E, Ingram KM. The role of disclosure patterns and unsupportive social interactions in the well-being of breast cancer patients. Psychooncology. 2004;13:96–105. doi: 10.1002/pon.717.
    1. Porter LS, Keefe FJ, Hurwitz H, Faber M. Disclosure between patients with gastrointestinal cancer and their spouses. Psychooncology. 2005;14:1030–1042. doi: 10.1002/pon.915.
    1. Porter LS, Keefe FJ, Baucom DH, Hurwitz H, Moser B, Patterson E, Kim HJ. Partner-assisted emotional disclosure for patients with gastrointestinal cancer: results from a randomized controlled trial. Cancer. 2009;115:4326–4338. doi: 10.1002/cncr.24578.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Sallis JF, Hovell MF, Hofstetter CR, Faucher P, Elder JP, Blanchard J, Caspersen CJ, Powell KE, Christenson GM. A multivariate study of determinants of vigorous exercise in a community sample. Prev Med. 1989;18:20–34. doi: 10.1016/0091-7435(89)90051-0.
    1. Borkovec T, Nau S. Credibility of analogue therapy rationales. Journal of Behavioral Therapy and Experimental Psychiatry. 1972;3:257–260. doi: 10.1016/0005-7916(72)90045-6.
    1. Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001;45:384–391. doi: 10.1002/1529-0131(200108)45:4<384::AID-ART352>;2-0.
    1. Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis & Rheumatism-Arthritis Care & Research. 2008;59:943–951.
    1. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002;21:2917–2930. doi: 10.1002/sim.1296.
    1. Fenwick E, Marshall DA, Levy AR, Nichol G. Using and interpreting cost-effectiveness acceptability curves: an example using data from a trial of management strategies for atrial fibrillation. BMC Health Serv Res. 2006;6:52. doi: 10.1186/1472-6963-6-52.
    1. Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ. 2002;11:415–430. doi: 10.1002/hec.678.
    1. van Baar ME, Assendelft WJ, Dekker J, Oostendorp RA, Bijlsma JW. Effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review of randomized clinical trials. Arthritis Rheum. 1999;42:1361–1369. doi: 10.1002/1529-0131(199907)42:7<1361::AID-ANR9>;2-9.
    1. Dixon KE, Keefe FJ, Scipio CD, Perri LM, Abernethy AP. Psychological interventions for arthritis pain management in adults: a meta-analysis. Health Psychol. 2007;26:241–250.
    1. Steultjens MP, Dekker J, Bijlsma JW. Coping, pain, and disability in osteoarthritis: a longitudinal study. J Rheumatol. 2001;28:1068–1072.
    1. Keefe FJ, Caldwell DS. Cognitive behavioral control of arthritis pain. Med Clin North Am. 1997;81:277–290. doi: 10.1016/S0025-7125(05)70515-0.
    1. Keefe FJ, Caldwell DS, Queen KT, Gil KM, Martinez S, Crisson JE, Ogden W, Nunley J. Pain coping strategies in osteoarthritis patients. J Consult Clin Psychol. 1987;55:208–212.
    1. Keefe FJ, Caldwell DS, Queen K, Gil KM, Martinez S, Crisson JE. et al.Osteoarthritis knee pain: a behavioural analysis. Pain. 1987;28:309–321. doi: 10.1016/0304-3959(87)90066-2.
    1. Penninx BW, Rejeski WJ, Pandya J, Miller ME, Di Bari M, Applegate WB, Pahor M. Exercise and depressive symptoms: a comparison of aerobic and resistance exercise effects on emotional and physical function in older persons with high and low depressive symptomatology. J Gerontol B Psychol Sci Soc Sci. 2002;57:P124–P132. doi: 10.1093/geronb/57.2.P124.
    1. Harrison AL. The influence of pathology, pain, balance, and self-efficacy on function in women with osteoarthritis of the knee. Phys Ther. 2004;84:822–831.

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