Efficacy of Combining Traditional Chinese Manual Therapy (Tuina) and Specific Therapeutic Neck Exercise in Young Adults with Non-Specific Chronic Neck Pain: Study Protocol for a Randomized Controlled Trial

Abstract

Purpose

Non-specific chronic neck pain (NSCNP) is an increasingly common musculoskeletal disease and an important issue in the global healthcare system. Some studies have shown that the combination of manual therapy and exercise is effective in treating NSCNP but still with several limitations. Traditional Chinese manual therapy (tuina) is a Chinese manual therapy that consists of soft tissue manipulation and spinal manipulation. This study aims to design a randomized controlled trial to assess the effect of a tuina combined with specific therapeutic neck exercise modified protocol for NSCNP patients.

Patients and Methods

This is a study protocol for a randomized, participant-, assessor- and analyst-blinded controlled trial. Eighty-eight eligible NSCNP patients will be randomly allocated into tuina combined with specific therapeutic neck exercise group (TSTE group) and tuina combined with sham therapeutic neck exercise group (TS group) in a ratio of 1:1. All participants will receive 8 treatment sessions applied in 4 weeks and then be followed up for another 12 weeks. Clinical data will be collected at baseline, during treatment phase (at the 2- and 4-week) and at the 8-, 12-, 16-week follow-ups. The primary outcome is the changes in neck pain intensity (visual analogue scale). The secondary outcomes include neck disability (Neck Disability Index), cervical range of motion (ROM), neck muscle endurance, cervical muscle cross-sectional area, cervical curvature and analgesic consumption. Adverse events will be collected and recorded throughout the study.

Conclusion

We will discuss whether our tuina combined with specific therapeutic neck exercise modified protocol is more effective at improving pericervical muscle endurance, ROM, cervical muscle cross-sectional area and cervical curvature than tuina alone, thereby decreases neck pain and disability in individuals with NSCNP more effectively.

Trial Registration

Chinese Clinical Trials Registry, ChiCTR2300067903. Registered on 31 January 2023.

Keywords:

• manual therapy
• non-specific neck pain
• specific therapeutic exercise
• randomized controlled trial

Abbreviations

AEs, Adverse events; CONSORT, Consolidated Standards of Reporting Trials; CSA, cross-sectional area; CRFs, case report forms; CROM, cervical range of motion; DEs, deep extensors; DFs, deep flexors; eCRF, electronic case report form; ICC, intra-tester reliability; ITT, intention-to-treat; MCID, minimal clinically important difference; NSCNP, Non-specific chronic neck pain; NDI, Neck Disability Index; ROI, region of interest; SEs, superficial extensors; SFs, superficial flexors; SPIRIT, Standard Protocol Items, Recommendations for Interventional Trials; Standard protocol items; TSTE, tuina combined with specific therapeutic neck exercise; TS, tuina combined with sham therapeutic neck exercise; VAS, visual analogue scale; VBAs, vertebral body areas.

Trial Status

Protocol: version 1.1, 31 January 2023.

The study launched on 31 January 2023 and participant recruitment is in progress now. Recruitment is expected to be completed by the end of December 2023.

Data Sharing Statement

The data in this trial will be publicly available from the corresponding author upon reasonable request. All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.

Ethics Approval and Informed Consent

The trial protocol has been approved by the ethics committee of Shanghai Municipal Hospital of Traditional Chinese Medicine on 30 May 2022 (No. 2022SHL-KY-29-02). All interested participants will be required to sign the written informed consent form with a clear understanding of the study before participating in. All methods will be conducted in accordance with the ethical standards of the declaration of Helsinki.

Acknowledgments

The authors would like to thank all the participants.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

The study is partly sponsored by the Future Plan for Traditional Chinese Medicine Inheritance and Development of Shanghai Municipal Hospital of Traditional Chinese Medicine (WLJH2021ZY-ZYY013), the Training Program for High-caliber Talents of Clinical Research at Affiliated Hospitals of SHUTCM (2023LCRC18), the Medical Research Program of Shanghai Xuhui District (SHXH202224), the Domestic Science and Technology Cooperation Project of Shanghai Science and Technology Innovation Action Plan (No. 22015830700). The study funder has no role in the study design, data collection, management, analysis, interpretation, or manuscript writing publication.