Baduanjin exercise with or without traditional Chinese tuina therapy for nonspecific chronic neck pain: study protocol for a randomised controlled trial

Introduction Non-pharmacological therapies in traditional Chinese medicine (TCM) play an important role in the management of nonspecific chronic neck pain (NCNP). Tuina therapy and Baduanjin exercise, representing passive and active modalities, respectively, have shown benefits in reducing pain, improving cervical mobility, and enhancing quality of life. However, the therapeutic efficacy of Tuina combined with Baduanjin (TCB) approach for NCNP remains insufficiently elucidated. This study aims to determine whether TCB provides superior effects in pain relief and functional outcomes compared with Baduanjin exercise alone. Methods and analysis A total of 110 NCNP patients aged 18 to 50 years will be recruited. Participants will be randomly assigned in a 1:1 ratio to either the TCB group or Baduanjin group. Each group will undergo a total of 16 sessions of therapy over 8 weeks, with two sessions per week. Outcomes will be assessed at week 8, 20, and 32 post-randomization. The primary outcome is the pain intensity at week 8, assessed by the visual analogue scale scores (VAS). Secondary outcomes include functional disability (evaluated with the Neck Disability Index), quality of life (assessed using the 12-item Short Form Survey questionnaire), emotional distress (measured by the Hospital Anxiety and Depression Scale), sleep quality (evaluated with the Pittsburgh Sleep Quality Index), work efficiency (assessed using the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem), and safety. The statistical analyses will follow the two-way repeated measures analysis of variance to compare clinical data between groups across different time points. Ethics and dissemination The study protocol has received approval from the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (2023-143). All study participants will be required to provide written informed consent. The findings of the study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences. Additionally, the participants will receive copies of the results upon requests. Clinical Trial Registration : https://www.chictr.org.cn/ , identifier (ChiCTR2300073680).