Efficacy of tuina in patients with chronic neck pain: study protocol for a randomized controlled trial

Abstract

Background: Chronic neck pain (CNP) is a common and disabling musculoskeletal disorder in developing and developed countries. Previous studies have shown that tuina and traditional Chinese massage are effective treatments for patients with CNP. However, there is little evidence to support the use of one intervention over the other. The aim of this study is to compare the effects of tuina and traditional Chinese massage in the treatment of pain and disability in patients with CNP.

Methods/design: This is a multicenter, assessor- and analyst-blinded, randomized controlled trial with two parallel arms: a tuina group and a traditional Chinese massage group. A total of 356 eligible CNP patients will be randomly assigned to the groups in a 1:1 ratio. The intervention in the tuina group includes both structural and relaxation massage, while the traditional Chinese massage group will receive relaxation massage only. The interventions for both groups will last for 15 min and will be carried out three times a week for a period of 4 weeks. The primary outcome will be changes in the Northwick Park Neck Pain Questionnaire. Secondary outcomes will be measured by a visual analogue scale (VAS), the Neck Disability Index (NDI), and the 36-item Short-Form Health Survey (SF-36). The data will be analyzed at the baseline, at the end of the intervention, and during the 3 months of follow-up by repeated measures analysis of variance. The significance level is 5%. The safety of tuina and traditional Chinese massage will be evaluated after each treatment session. The results of this trial will help clarify the value of tuina and traditional Chinese massage as treatments for CNP and will highlight any differences in the efficacy of the treatments.

Discussion: The purpose of this trial is to determine whether tuina is more effective than traditional Chinese massage in adults with CNP. This trial will, therefore, contribute to providing a solid foundation for clinical treatment of CNP, as well as future research in massage therapy.

Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-17013763 . Registered 8 December 2017.

Keywords: Chronic neck pain; Efficacy; Randomized controlled trial; Tuina; traditional Chinese massage.

Fig. 1

Flow chart of the study. A total of 356 participants will be randomized to the two groups. The interventions will last for 15 min and will be carried out three times a week for 4 weeks. The study period will be consisted of the baseline, 2 weeks of treatment, after treatment, 1.5 and 3-month follow-up. NDI Neck Disability Index, NPQ Northwick Park Neck Pain Questionnaire, SF-36 36-item Short-Form Health Survey

Fig. 2

Study schedule showing time points for enrollment and assessment. NDI Neck Disability Index, NPQ Northwick Park Neck Pain Questionnaire, SF-36 36-item Short-Form Health Survey, VAS visual analogue scale, W-1 screening before enrollment, W0 baseline assessment, W2 assessment after the sixth treatment, which is in the second week, W4 assessment after the 12th treatment, which is in the fourth week, W10 assessment 10 weeks after the first treatment, W16 assessment 16 weeks after the first treatment