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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial

Authors: Ho Jeong Do, Joon-Shik Shin, Jinho Lee, Yoon Jae Lee, Me-riong Kim, Jae-Heung Cho, Koh-Woon Kim, In-Hyuk Ha

Published in: Trials | Issue 1/2018

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Abstract

Background

Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints.

Methods/Design

This study is the protocol for a two-armed parallel, assessor-blinded, multicenter, randomized controlled trial. A total 108 patients with chronic neck pain (time to onset ≥ 3 months, numeric rating scale [NRS] of neck pain ≥ 5) will be recruited at five Korean medicine hospital sites. Participants will be allotted to one of two groups (n = 54, respectively): the Chuna manual therapy group, and the usual care (conventional physical therapy and medication treatment) group. Ten sessions of Chuna manual therapy or usual care will be administered twice a week for five weeks. Since the study design does not permit patient or physician blinding, the outcome assessor and statistician will be blinded. The primary outcome will be the visual analogue scale (VAS) of neck pain at 5 weeks after randomization. Secondary outcomes include the VAS of radiating arm pain, NRS of neck pain and radiating arm pain, Vernon-Mior neck disability index (NDI), Northwick Park neck pain questionnaire (NPQ), EuroQol-5 Dimension (EQ-5D), EQ-VAS, patient global impression of change (PGIC), economic evaluation, adverse effects, and drug consumption. Follow-up outcome assessments will be conducted at 3, 6, 9, and 12 months after randomization.

Discussion

This study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy.

Trial registration

Clinical Research Information Service (CRIS), KCT0002732. Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785. Registered on 27 September 2017.
Appendix
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Literature
1.
Bogduk N, McGuirk B, Guierre A. Prise en charge des cervicalgies aiguës et chroniques: une approche fondée sur les preuves. Paris: Elsevier Masson; 2011.
2.
Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006;15(6):834–48.PubMedCrossRef
3.
Murray CJ, Abraham J, Ali MK, Alvarado M, Atkinson C, Baddour LM, et al. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013;310(6):591–606.PubMedCrossRef
4.
Côté P, Cassidy JD, Carroll L. The Saskatchewan health and back pain survey: the prevalence of neck pain and related disability in Saskatchewan adults. Spine. 1998;23(15):1689–98.PubMedCrossRef
5.
Borghouts JA, Koes BW, Bouter LM. The clinical course and prognostic factors of non-specific neck pain: a systematic review. Pain. 1998;77(1):1–13.PubMedCrossRef
6.
Linton SJ, Hellsing A-L, Halldén K. A population-based study of spinal pain among 35-45-year-old individuals: prevalence, sick leave, and health care use. Spine. 1998;23(13):1457–63.PubMedCrossRef
7.
Skargren EI, Öberg BE. Predictive factors for 1-year outcome of low-back and neck pain in patients treated in primary care: comparison between the treatment strategies chiropractic and physiotherapy. Pain. 1998;77(2):201–7.PubMedCrossRef
8.
Côté P, Kristman V, Vidmar M, Van Eerd D, Hogg-Johnson S, Beaton D, et al. The prevalence and incidence of work absenteeism involving neck pain: a cohort of Ontario lost-time claimants. J Manip Physiol Ther. 2009;32(2):S219–26.CrossRef
9.
Cassou B, Derriennic F, Monfort C, Norton J, Touranchet A. Chronic neck and shoulder pain, age, and working conditions: longitudinal results from a large random sample in France. Occup Environ Med. 2002;59(8):537–44.PubMedPubMedCentralCrossRef
10.
Park JM, Shin SW, Park JH. Comparative study on concepts of Chuna manipulative therapy (in Korean). J Oriental Med Class. 2008;21(2):173–91.
11.
Korean Society of Chuna Manual Medicine for Spine & Nerves, editor. Chuna Manual Medicine. 3rd ed. Seoul, Korea: Korean Society of Chuna Manual Medicine for Spine & Nerves; 2014.
12.
Gross A, Langevin P, Burnie SJ, Bédard-Brochu MS, Empey B, Dugas E, et al. Manipulation and mobilisation for neck pain contrasted against an inactive control or another active treatment. Cochrane Database Syst Rev. 2015;23(9):CD004249.
13.
Smith J, Bolton PS. What are the clinical criteria justifying spinal manipulative therapy for neck pain? A systematic review of randomized controlled trials. Pain Med. 2013;14(4):460–8.PubMedCrossRef
14.
Gross A, Miller J, D’Sylva J, Burnie SJ, Goldsmith CH, Graham N, et al. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther. 2010;15(4):315–33.PubMedCrossRef
15.
Senstad O, Leboeuf-Yde C, Borchgrevink C. Frequency and characteristics of side effects of spinal manipulative therapy. Spine. 1997;22(4):435–40.PubMedCrossRef
16.
Korean Society of Chuna Manual Medicine for Spine & Nerves, editor. Chuna Manual Medicine. 2.5th ed: Korean Society of Chuna Manual Medicine for Spine & Nerves; 2017.
17.
Park JJ, Shin J, Choi Y, Youn Y, Lee S, Kwon S-R, et al. Integrative package for low back pain with leg pain in Korea: a prospective cohort study. Complement Ther Med. 2010;18(2):78–86.PubMedCrossRef
18.
19.
Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27(1):117–26.PubMedCrossRef
20.
Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–58.PubMedCrossRef
21.
Turk DC, Rudy TE, Sorkin BA. Neglected topics in chronic pain treatment outcome studies: determination of success. Pain. 1993;53(1):3–16.PubMedCrossRef
22.
Guy W. ECDEU assessment manual for psychopharmacology, vol. 76: US Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976.
23.
Gusi N, Olivares P, Rajendram R. The EQ-5D health-related quality of life questionnaire. In: Handbook of disease burdens and quality of life measures. New York: Springer; 2010. p. 87–99.
24.
Nam H, Kim K, Kwon S, Koh K, Poul K. EQ-5D Korean valuation study using time trade of method. Seoul: Korea Centers for Disease Control and Prevention; 2007.
25.
Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston: Health Assessment Lab; 2000.
26.
Berger ML, Bingefors K, Hedblom EC, Pashos C, Torrance GW. Health Care Cost, Quality, and Outcomes: ISPOR Book of Terms. Lawrenceville: ISPOR; 2003.
27.
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
28.
Rascati K. Essentials of pharmacoeconomics. Philadelphia: Lippincott Williams & Wilkins; 2013.
29.
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86.PubMedCrossRef
30.
Ryu HS, Jeon SH, Park DS, Lee SG. Clinical trial of chuna manipulative therapy in neck pain patients with less-than-normal cervical curvature (in Korean). J Korea CHUNA Manual Med Spine Nerves. 2006;1(2):11–20.
31.
Shin B-C, Kim S-D, Lee MS. Comparison between the effects of Chuna manipulation therapy and cervical traction treatment on pain in patients with herniated cervical disc: a randomized clinical pilot trial. Am J Chinese Med. 2005;34(5):923–5.
32.
Blödt S, Pach D, Roll S, Witt CM. Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials. Trials. 2014;15(1):490.PubMedPubMedCentralCrossRef
33.
van Geest S, Kuijper B, Oterdoom M, van den Hout W, Brand R, Stijnen T, et al. CASINO: Surgical or Nonsurgical Treatment for cervical radiculopathy, a randomised controlled trial. BMC Musculoskelet Disord. 2014;15(1):129.PubMedPubMedCentralCrossRef
34.
Hudson JS, Ryan CG. Multimodal group rehabilitation compared to usual care for patients with chronic neck pain: a pilot study. Man Ther. 2010;15(6):552–6.PubMedCrossRef
35.
Williams NH, Wilkinson C, Russell I, Edwards RT, Hibbs R, Linck P, et al. Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care. Fam Pract. 2003;20(6):662–9.PubMedCrossRef
36.
Jull G, Kenardy J, Hendrikz J, Cohen M, Sterling M. Management of acute whiplash: a randomized controlled trial of multidisciplinary stratified treatments. PAIN®. 2013;154(9):1798–806.CrossRef
37.
MacPherson H, Tilbrook HE, Richmond SJ, Atkin K, Ballard K, Bland M, et al. Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial. Trials. 2013;14(1):209.PubMedPubMedCentralCrossRef
38.
MacPherson H, Tilbrook H, Richmond S, Woodman J, Ballard K, Atkin K, et al. Alexander Technique lessons or acupuncture sessions for persons with chronic neck pain: a randomized trial. Ann Intern Med. 2015;163(9):653–62.PubMedCrossRef
39.
Pfister DG, Cassileth BR, Deng GE, Yeung KS, Lee JS, Garrity D, et al. Acupuncture for pain and dysfunction after neck dissection: results of a randomized controlled trial. J Clin Oncol. 2010;28(15):2565–70.PubMedPubMedCentralCrossRef
40.
Metadata
Title
Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial
Authors
Ho Jeong Do
Joon-Shik Shin
Jinho Lee
Yoon Jae Lee
Me-riong Kim
Jae-Heung Cho
Koh-Woon Kim
In-Hyuk Ha
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3016-6

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