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      Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial

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          Abstract

          Background

          Knee osteoarthritis (KOA) is commonly seen and has a high occurrence in the middle-aged and elderly. It is characterized by the degeneration and secondary bone hyperplasia of the articular cartilage; the pathologic changes are irreversible. Therefore, treatment of KOA is mainly focused on relieving pain, reducing inflammation, improving or restoring joint function, delaying disease progression, and increasing quality of life. Crossbow needle therapy of the Miao ethnic minority group is intended for KOA treatment and has been widely used. Studies of small sample size have seen significant improvement on pain relief, stiffness, and joint function.

          Methods/design

          The trial is a randomized, multicenter, parallel, non-inferiority study. Three hundred and six patients will be randomly assigned to a crossbow needle group ( n = 153) and an acupuncture group ( n = 153). Patients in each group will receive treatment every other day, three times a week, 20 times in total. Follow-up will be conducted 15 days and 30 days after treatment. The primary outcome will be the Western Ontario and McMaster Osteoarthritis Index (WOMAC) score at baseline, the end of treatment, first follow-up, and second follow-up. The secondary outcomes will include Lysholm knee score, Japanese Orthopedic Association (JOA) knee score, visual analogue scale (VAS), and the MOS 36-item short-form health survey (SF-36).

          Discussion

          The results of the trial will compare the efficacy on KOA between crossbow needle group and acupuncture group and will be expected to make a systematic and objective evaluation of crossbow needle therapy.

          Trial registration

          ChiCTR, ChiCTR-INR-16008032. Registered on 12 March 2016.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2730-4) contains supplementary material, which is available to authorized users.

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          Most cited references30

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          Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity.

          Bhushan Deshpande, Jeffrey Katz, Daniel Solomon … (2016)
          The prevalence of symptomatic knee osteoarthritis (OA) has been increasing over the past several decades in the US, concurrent with an aging population and the growing obesity epidemic. We quantify the impact of these factors on the number of persons with symptomatic knee OA in the early decades of the 21st century.
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            Acupuncture in patients with osteoarthritis of the knee: a randomised trial.

            C Witt, B. Brinkhaus, S. Jena … (2015)
            Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee. Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat. 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08). After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.
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              Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial.

              M Hochberg, Adele Gilpin, B Berman … (2004)
              Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal. To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee. Randomized, controlled trial. Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and 1 clinical trials facility. 570 patients with osteoarthritis of the knee (mean age [+/-SD], 65.5 +/- 8.4 years). 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36). Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, -2.9 [95% CI, -5.0 to -0.8]; P = 0.01) but not in WOMAC pain score (mean difference, -0.5 [CI, -1.2 to 0.2]; P = 0.18) or the patient global assessment (mean difference, 0.16 [CI, -0.02 to 0.34]; P > 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, -2.5 [CI, -4.7 to -0.4]; P = 0.01), WOMAC pain score (mean difference, -0.87 [CI, -1.58 to -0.16];P = 0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P = 0.02). At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis. Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups.
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                Author and article information

                Contributors
                Jing Fu: 1040684089@qq.com
                Hong-cai Shang: shanghongcai@126.com
                Li-ying Wang: coldmoon_ly@163.com
                Chen Zhao: zyyzc2007@163.com
                Jin Cui:
                ORCID: http://orcid.org/0000-0002-0106-2620
                516260179@qq.com
                Yan-ping Wang: wangyanping4816@163.com
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1745-6215
                Publication date (Electronic): 27 June 2018
                Publication date PMC-release: 27 June 2018
                Publication date Collection: 2018
                Volume: 19
                Electronic Location Identifier: 338
                Affiliations
                [1 ]ISNI 0000 0004 1762 5410, GRID grid.464322.5, Guiyang University of Chinese Medicine, ; Guiyang, 550000 China
                [2 ]ISNI 0000 0001 1431 9176, GRID grid.24695.3c, Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, , Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, ; Beijing, 100700 China
                [3 ]ISNI 0000 0004 0632 3409, GRID grid.410318.f, Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences, ; Beijing, 100700 China
                [4 ]ISNI 0000 0001 1816 6218, GRID grid.410648.f, Tianjin University of Traditional Chinese Medicine, ; Tianjin, 300193 China
                Author information
                http://orcid.org/0000-0002-0106-2620
                Article
                Publisher ID: 2730
                DOI: 10.1186/s13063-018-2730-4
                PMC ID: 6020384
                PubMed ID: 29945672
                SO-VID: ccc18b35-4c3a-4227-af9e-815237d141cc
                Copyright © © The Author(s). 2018
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 7 August 2017
                Date accepted : 8 June 2018
                Funding
                Funded by: Special Research Project of Traditional Chinese Medicine
                Award ID: 201507006-01
                Award Recipient :
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2018

                ScienceOpen disciplines: Medicine
                Keywords: koa,crossbow needle therapy,acupuncture,randomized controlled trial
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: koa, crossbow needle therapy, acupuncture, randomized controlled trial

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