Clinical Efficacy Evaluation of Tuina Combined Medicated Oil in the Treatment of Nonspecific Low Back Pain: Protocol for a Randomized Controlled Trial.

BACKGROUND

Nonspecific low back pain (NSLBP) is a significant global public health concern that affects the health and well-being of individuals across different age groups, limiting their daily activities and reducing their quality of life. As Tuina (Chinese therapeutic massage) therapy and medicated oil are widely used in China, it is necessary to design a randomized clinical trial to assess the effectiveness of Tuina combined medicated oil (TNO) in treating NSLBP.

OBJECTIVE

This study aims to evaluate the efficacy and safety of Tuina therapy combined with medicated oil in treating NSLBP.

METHODS

One hundred participants will be enrolled and randomly allocated to either a TNO group (n=50) or a Tuina combined water group (n=50). Treatment will last for 4 weeks, with sessions 3 times a week, followed by a 4-week follow-up. The visual analog scale score is the primary outcome; secondary outcomes include the evaluation of treatment Japanese Orthopaedic Association scores, infrared thermography, muscle tension tests, and tenderness scores. All adverse reactions will be recorded.

RESULTS

The trial commenced in June 2023 and is expected to conclude in September 2025. In June 2025, key preliminary steps were completed, and the ethical review and clinical trial registration were concluded. Recruitment is proceeding as planned, with 100 participants enrolled to date. Data collection is underway, while formal data analysis has not yet commenced.

CONCLUSIONS

The project's purpose is to evaluate the effectiveness of TNO in alleviating pain and improving lumbar function in patients with NSLBP.