Observation of the efficacy of acupuncture in promoting recovery after hip fracture surgery: a study protocol for a randomized controlled trial
摘要
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.
MethodsThe 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.
DiscussionThis 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 registrationClinicalTrials.gov Identifier: ITMCTR2025001644.