Comparing the effects of individualized, standard, sham and no acupuncture in the treatment of knee osteoarthritis: a multicenter randomized controlled trial

Eun-Jung Kim, Chi-Yeon Lim, Eun-Yong Lee, Seung-Deok Lee, Kap-Sung Kim, Eun-Jung Kim, Chi-Yeon Lim, Eun-Yong Lee, Seung-Deok Lee, Kap-Sung Kim

Abstract

Background: Acupuncture is an effective yet complex therapy, integrating syndrome differentiation, selection of appropriate acupoints and skillful needling techniques. Clinicians carefully tailor acupuncture treatment to each patient. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individualdifferences and, as a result, have not been reflective of the true efficacy of clinical practice. To determine the efficacy of meridian-based syndrome differentiation and Sa-am acupuncture, we have designed a simple pragmatic trial providing individualized treatments while working within a general framework.

Methods/design: The study is designed to be a parallel, patient- and assessor-blind, randomized controlled trial (RCT). A total of250 patients with knee osteoarthritis (OA) will be recruited from two independent hospitals, Semyung University Oriental Medicine Hospital in Chung-ju and Dongguk University Oriental Hospital in Ilsan, South Korea. Patients will be randomly allocated into four treatment groups: 1. individualized, meridian-based syndrome differentiation and Sa-am acupuncture treatment;2. standard acupuncture treatment;3. sham acupuncture treatment; and 4. no acupuncture treatment. Patients in groups 1 to 3 will be treated by certified oriental medicine doctors twice a week for 6 weeks. The primary outcome measure will be the self-reported total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change. The trial will also include secondary outcome measures.

Discussion: This trial is designed to determine the efficacy of individualized acupuncture treatment in patients with knee OA by comparing the differences between individualized, standard, sham and no acupuncture treatments. The results of this trial may validate the efficacy of individualized acupuncture therapy, encouraging its widespread use.

Trial registration: ClinicalTrials.gov: NCT01569230.

References

    1. Avins AL, Cherkin DC, Sherman KJ, Goldberg H, Pressman A. Should we reconsider the routine use of placebo controls in clinical research? Trials. 2012;13:44. doi: 10.1186/1745-6215-13-44.
    1. Frass M, Strassl RP, Friehs H, Mullner M, Kundi M, Kaye AD. Use and acceptance of complementary and alternative medicine among the general population and medical personnel: a systematic review. Ochsner J. 2012;12:45–56.
    1. Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ. 2004;329:1317. doi: 10.1136/bmj.38273.626655.63.
    1. Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990–2020: Global Burden of Disease Study. Lancet. 1997;349:1498–1504. doi: 10.1016/S0140-6736(96)07492-2.
    1. Quandt SA, Chen H, Grzywacz JG, Bell RA, Lang W, Arcury TA. Use of complementary and alternative medicine by persons with arthritis: results of the National Health Interview Survey. Arthritis Rheum. 2005;53:748–755. doi: 10.1002/art.21443.
    1. Herman CJ, Allen P, Hunt WC, Prasad A, Brady TJ. Use of complementary therapies among primary care clinic patients with arthritis. Prev Chronic Dis. 2004;1:A12.
    1. 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. doi: 10.1186/1745-6215-12-160.
    1. Kelly RB. Acupuncture for pain. Am Fam Physician. 2009;80:481–484.
    1. Zhibin Z, Yongyan W. Research on TCM syndrome nomenclature and classification: review and hypothesis. Journal of Beijing University of Traditional Chinese Medicine. 2003;2:1–5.
    1. MacPherson H. Out of the laboratory and into the clinic: acupuncture research in the real world. ClinAcupunct Oriental Med. 2000;1:97–100. doi: 10.1054/caom.2000.0044.
    1. Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003;3:28. doi: 10.1186/1471-2288-3-28.
    1. Macpherson H. Pragmatic clinical trials. ComplementTher Med. 2004;12:136–140. doi: 10.1016/j.ctim.2004.07.043.
    1. White AR. Acupuncture in practice: case history insights from the west. FocusAltern Complement Ther. 1997;2:83.
    1. Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture in patients with osteoarthritis of the knee or hip: a randomized, controlled trial with an additional nonrandomized arm. Arthritis Rheum. 2006;54:3485–3493. doi: 10.1002/art.22154.
    1. Lansdown H, Howard K, Brealey S, MacPherson H. Acupuncture for pain and osteoarthritis of the knee: a pilot study for an open parallel-arm randomised controlled trial. BMCMusculoskeletDisord. 2009;10:130.
    1. Linde K, Weidenhammer W, Streng A, Hoppe A, Melchart D. Acupuncture for osteoarthritic pain: an observational study in routine care. Rheumatology (Oxford) 2006;45:222–227.
    1. Molsberger AF, Streitberger K, Kraemer J, Brittinger CS, Witte S, Boewing G, Haake M. Designing an acupuncture study: II. The nationwide, randomized, controlled German acupuncture trials on low-back pain and gonarthrosis. JAltern Complement Med. 2006;12:733–742. doi: 10.1089/acm.2006.12.733.
    1. Sun P. TheManagement of Post-operative Pain with Acupuncture. Philadelphia, PA: Churchill Livingstone; 2007.
    1. Jarmey C, Bouratinos I. A Practical Guide to Acu-points. Berkeley, CA: North Atlantic Books; 2008.
    1. Xiao F. The third model of point classification. Journal of Chinese Medicine. 2001;67:16–21.
    1. Yoon EH, Jung CY, Jang MG, Lee SD, Nam DW, Kim HW, Lee EY, Cho HS, Lee GM, Lee JD, Kim SW, Kim KS. E-mail survey for developing clinical trial protocol on acupuncture treatment for knee pain. JKorAcupunctMoxibust Soc. 2009;26:59–65.
    1. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, Howell D, Kaplan D, Koopman W, Longley S 3rd, Mankin H, McShane DJ, Medsger T Jr, Mennan R, Mikkelsen W, Moskowitz R, Murphy W, Rothschild B, Segal M, Sokoloff L, Wolfe F. 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. Park J, White A, Lee H, Ernst E. Development of a new sham needle. Acupunct Med. 1999;17:110–112. doi: 10.1136/aim.17.2.110.
    1. Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med. 2002;20:168–174. doi: 10.1136/aim.20.4.168.
    1. Yin C, Park HJ, Chae Y, Ha E, Park HK, Lee HS, Koh H, Kang S, Choi S, Ryu Y, Lee H. Korean acupuncture: the individualized and practical acupuncture. Neurol Res. 2007;29(Suppl 1):10–15.
    1. Ahn CB, Jang KJ, Yoon HM, Kim CH, Min YK, Song CH, Lee JC. Sa-Ahm five element acupuncture. JAcupunct Meridian Stud. 2010;3:203–213. doi: 10.1016/S2005-2901(10)60037-4.
    1. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004;141:901–910. doi: 10.7326/0003-4819-141-12-200412210-00006.
    1. Park J, White AR, James MA, Hemsley AG, Johnson P, Chambers J, Ernst E. Acupuncture for subacute stroke rehabilitation: a sham-controlled, subject- and assessor-blind, randomized trial. Arch Intern Med. 2005;165:2026–2031. doi: 10.1001/archinte.165.17.2026.
    1. Smith P, Mosscrop D, Davies S, Sloan P, Al-Ani Z. The efficacy of acupuncture in the treatment of temporomandibular joint myofascial pain: a randomised controlled trial. J Dent. 2007;35:259–267. doi: 10.1016/j.jdent.2006.09.004.
    1. Kennedy S, Baxter GD, Kerr DP, Bradbury I, Park J, McDonough SM. Acupuncture for acute non-specific low back pain: a pilot randomised non-penetrating sham controlled trial. ComplementTher Med. 2008;16:139–146. doi: 10.1016/j.ctim.2007.03.001.
    1. 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. JRheumatol. 1988;15:1833–1840.
    1. Bellamy N. WOMAC Osteoarthritis Index: User Guide IX. Queensland: WOMAC; 2009.
    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. Scharf HP, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C, Trampisch HJ, Victor N. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006;145:12–20. doi: 10.7326/0003-4819-145-1-200607040-00005.
    1. Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. PhysTher. 2005;85:1301–1317.
    1. Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST) JAMA. 1997;277:25–31. doi: 10.1001/jama.1997.03540250033028.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir