: 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). : 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.
Wu et al. (Sun,) studied this question.