Observation of the efficacy of acupuncture in promoting recovery after hip fracture surgery: a study protocol for a randomized controlled trial.

BACKGROUND: Postoperative patients with hip fractures (HFs) frequently experience severe pain, swelling, and restricted mobility in the affected joint, substantially compromising their quality of life. As a non-pharmacological intervention, acupuncture has shown promise in supporting rehabilitation following various fractures, a notion corroborated by a growing body of clinical research. Therefore, this study aims to systematically assess the efficacy and safety of acupuncture in promoting postoperative recovery among patients after HF surgery. METHODS: The study will randomly divide 244 patients into either the acupuncture group or the sham acupuncture group with an allocation ratio of 1:1. All patients will receive four treatments within a one-week period and a follow-up evaluation one month after the treatment course. The primary outcome will be measured using the Harris Hip Score (HHS). Secondary outcomes will include the Visual Analog Scale (VAS), the Self-Rating Depression scale (SDS), the Self-Rating Anxiety scale (SAS), the lower extremity swelling scale, levels of inflammatory factor level (IL-2, IL-6, TNF-α), the Short Form 36 Health Survey (SF-36), rate of remedial analgesia, the blinded assessment, and the treatment expectations scale. Safety will be assessed throughout the trial. All results will be analyzed following the intention-to-treat principle. DISCUSSION: This prospective trial will provide high-quality evidence for evaluating the effectiveness and safety of acupuncture in postoperative recovery from HF, and the results may provide new options for clinical treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: ITMCTR2025001644.