Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

Trials

Qing Zhang¹  Bihong Zhou¹  Baojun Chen¹  Xueyi Lin¹  Guohua Zheng¹  Lidian Chen¹  Youxin Su¹  Hu Yan¹ 

[1] Fujian University of Traditional Chinese Medicine, 1 Huatuo St, Shangjie, Minhou, Fuzhou, Fujian, China

关键词: Clinical trial;    Rehabilitation;    Traditional Chinese medicine;    Knee osteoarthritis;   

Others  :  807946
DOI  :  10.1186/1745-6215-14-367

 received in 2012-12-29, accepted in 2013-10-18,  发布年份 2013

【 摘 要 】

Background

It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center.

Method/design

This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health-related quality-of-life assessments. Other outcomes will include rate of adverse events and economic effects. Relative cost-effectiveness will be determined from health service usage and outcome data.

Discussion

The primary aim of this trial is to develop a standard protocol for traditional Chinese medicine, which can be adopted by community health centers in China and worldwide, for the rehabilitation of patients with knee osteoarthritis.

Trial registration

Clinical Trials Registration: ChiCTR-TRC-12002538

【 授权许可】

   
2013 Yan et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Dominick KL, Ahern FM, Gold CH, Heller DA: Health-related quality of life among older adults with arthritis. Health Qual Life Outcomes 2004, 2:5. BioMed Central Full Text
• [2]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. Osteoarthritis Cartilage 2010, 18:476-499.
• [3]Felson DT, Zhang Y, Hannan MT, Naimark A, Weissman B, Aliabadi P, Levy D: Risk factors for incident radiographic knee osteoarthritis in the elderly: the Framingham Study. Arthritis Rheum 1997, 40:728-733.
• [4]Liu XX, Su YX: Integrative medical: Clinical rehabilitation therapy research of ten diseases. Beijing: Science and Technology Press; 2011.
• [5]Fryback DG, Dasbach EJ, Klein R, Klein BE, Dorn N, Peterson K, Martin PA: The Beaver Dam Health Outcomes Study: initial catalog of health-state quality factors. Med Decis Making 1993, 13:89-102.
• [6]Zhang W, Moskowitz RW, Nuki G, 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 I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthr Cartilage 2007, 15:981-1000.
• [7]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 2007, 30:2-12.
• [8]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.
• [9]Dieppe PA, Lohmander LS: Pathogenesis and management of pain in osteoarthritis. Lancet 2005, 365:965-973.
• [10]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.
• [11]Dieppe PA: Relationship between symptoms and structural change in osteoarthritis: what are the important targets for therapy? Rheumatol 2005, 32:1147-1149.
• [12]Eitzen I, Holm I, Risberg MA: Preoperative quadriceps strength is asignificant predictor of knee function two years after anterior cruciate ligament reconstruction. Br J Sports Med 2009, 43:371-376.
• [13]Zhang W, Moskowitz R, 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 kneeosteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008, 16:137-162.
• [14]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. Osteoarthritis Cartilage 2007, 15:981-1000.
• [15]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.
• [16]Li XH, Wu MX, Ye HZ, Chen WL, Lin JM, Zheng LP, Liu XX: Experiment study on the suppression of sodium nitroprussiate-induced chondrocyte apoptosis by Touguxiaotong capsule-containing serum. Clin J Integr Med 2011, 17:436-443.
• [17]Hinman RS, McCrory P, Pirotta M, Relf I, Crossley KM, Reddy P, Forbes A, Harris A, Metcalf BR, Kyriakides M, Novy K, Bennell KL: Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design. BMC Complement Altern Med 2012, 12:161. BioMed Central Full Text
• [18]Wang X, Cao Y, Pang J, Du J, Guo C, Liu T, Wei S, Zheng Y, Chen R, Zhan H: Traditional chinese herbal patch for short-term management of knee osteoarthritis: a randomized, double-blind, placebo-controlled trial. Evid Based Complement Alternat Med 2012, 2012:171706.
• [19]Cao Y, Zhan H, Pang J, Li F, Xu S, Gao J, Xu Z, Li G, Liu T, Guo C, Shi Y: Individually integrated traditional Chinese medicine approach in the management of knee osteoarthritis: study protocol for a randomized controlled trial. Trials 2011, 12:160. BioMed Central Full Text
• [20]Tsai PF, Chang JY, Chowdhury N, Beck C, Roberson PK, Rosengren K: Enrolling older adults with cognitive impairment in research: lessons from a study of Tai Chi for osteoarthritis knee pain. Res Gerontol Nurs 2009, 2:228-234.
• [21]Li SS, Wu YC: Ten years therapy survey of knee osteoarthritis: lack of acceptable evaluation standard and therapy protocol. China tissue Eng Res Clin Rehabil 2010, 14:5268-5271.
• [22]Chinese Orthopaedic Association: Therapy guide of knee osteoarthritis. Chin J Orthopaedics 2007, 27:793-796.
• [23]Guo J, Jin SG: Sample estimation: Cluster randomization test design. Chin J Health Stat 2008, 25:117-119.
• [24]Wang HM: Orthopedics and Traumatology of Traditional Chinese Medicine. Beijing: China Chinese medicine press; 2007.
• [25]Nan DK: Practical rehabilitation medicine. Beijing: People's Medical Publishing House; 2009.
• [26]Fransen M, McConnell S, Bell M: Exercise for osteoarthritis of the hip or knee. Cochrane Database Syst Rev 2003, 3:CD004286.
• [27]Bellamy N: Osteoarthritis clinical trials: candidate variables and clinimetric properties. J Rheumatol 1997, 24:768-778.
• [28]Soderberg GL, Ballantyne BT, Kestel LL: Reliability of lower extremity girth measurements after anterior cruciate ligament reconstruction. Physiother Res Int 1996, 1:7-16.
• [29]Rothstein JM, Miller PJ, Roettger RF: Goniometric reliability in a clinical setting. Elbow and knee measurements. Phys Ther 1983, 63:1611-1615.
• [30]Scott OM, Hyde SA, Goddard C, Dubowitz V: Quantitation of muscle function in children: a prospectivestudy in Duchenne muscular dystrophy. Muscle Nerve 1982, 5:291-301.
• [31]Tsai YA, Chuang TY, Yen YS, Huang MC, Lin PH, Cheng H: Electrophysiologic findings and muscle strength grading in brachioplexopathies. Microsurgery 2002, 22:11-15.
• [32]Mizner RL, Snyder-Mackler L: Altered loading during walking and sit-to-stand is affected by quadriceps weakness after total knee arthroplasty. J Orthop Res 2005, 23:1083-1090.
• [33]Steffen TM, Hacker TA, Mollinger L: Age-and gender-related test performance in community dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther 2002, 82:128-137.
• [34]Rejeski WJ, Ettinger WH Jr, Schumaker S, James P, Burns R, Elam JT: Assessing performance-related disability in patients with knee osteoarthritis. Osteoarthritis Cartilage 1995, 3:157-167.
• [35]Zheng XY: The clinical research : guide principal of new drugs in Traditional Chinese Medicine. Beijing: Chinese medicine and technology publishing house; 2002.
• [36]Leung SO, Chan CC, Shah S: Development of a Chinese version of the Modified Barthel Index – validity and reliability. Clin Rehabil 2007, 21:912-922.
• [37]Sibbritt D, van der Riet P, Dedkhard S, Srithong K: Rehabilitation of stroke patients using traditional Thai massage, herbal treatments and physical therapies. J Chin integr Med 2012, 10:743-750.
• [38]Ware JE Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A: Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care 1995, 33:264-279.
• [39]Brazier JE, Harper R, Munro J, Walters SJ, Snaith ML: Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford) 1999, 38:870-877.
• [40]Ware JE Jr, Snow KK, Kosinski M, Gandek B: SF-36 Health Survey: manual and interpretation guide. Boston, MA: Nimrod Press; 1993.
• [41]Molenberghs G, Kenward M: Missing Data in Clinical Studies. Chichester, UK: John Wiley and Sons Ltd; 2007.