Synergistic therapeutic effects of Haitongpi Decoction fumigation combined with professional rehabilitation supervision in the treatment of frozen shoulder: A randomized controlled trial

: Frozen shoulder (FS) is a prevalent chronic musculoskeletal disorder in middle-aged and elderly populations, characterized by persistent shoulder pain and progressive mobility limitation. Conventional self-rehabilitation combined with traditional Chinese medicine (TCM) fumigation is widely used but constrained by poor patient adherence and lack of professional guidance, limiting therapeutic efficacy. : To systematically assess the clinical efficacy and safety of professional rehabilitation supervision (PRS) combined with TCM (Haitongpi Decoction) fumigation for frozen shoulder, and to provide evidence-based support for optimizing clinical treatment regimens. : A prospective randomized controlled trial included 80 frozen shoulder patients (August 2022-May 2024), who were randomly assigned into observation ( n = 40) and control ( n = 40) groups, and were treated with Haitongpi Decoction fumigation and basic medication. The control and observation groups separately adopted routine self-rehabilitation and PRS. Clinical efficacy, pre-/post-treatment Visual Analogue Scale (VAS), Constant-Murley Score (CMS), serum interleukin-10 (IL-10) and tumor necrosis factor-α (TNF-α) levels, and adverse reactions were compared between the two groups. The study protocol was approved by the Ethics Committee of Yiwu Central Hospital (approval number: 2022-IRB-030). The trial was registered with the International Traditional Medicine Clinical Trial Registry (Registration No. ITMCTR2026000102). : The observation group (87.50%) had a higher total effective rate than the control group (67.50%, P < 0.05). After treatment, the observation group presented VAS reduction, CMS increase, IL-10 elevation and TNF-α reduction compared to the control group ( P < 0.05), while there was no significant difference in adverse reactions ( P > 0.05). : PRS combined with TCM fumigation is effective and safe, significantly relieving pain, improving shoulder function and reducing inflammation in frozen shoulder, which is worthy of clinical promotion.