Effect of Acupuncture Intervention on Chronic Musculoskeletal Pain in Hemodialysis-Dependent Kidney Failure Patients: Study Protocol for a Randomized Controlled Clinical Trial.

Background: Chronic musculoskeletal pain is prevalent in individuals with hemodialysis-dependent renal failure (HDKF). The current opioid crisis highlights the urgent need for effective non-pharmacological pain management. Acupuncture, identified as a non-pharmacological intervention in clinical settings, holds promise for alleviating chronic musculoskeletal pain in HDKF patients, but well-designed studies assessing its specific effects in this population are lacking. This study aims to comprehensively evaluate the efficacy and safety of acupuncture as a treatment modality for HDKF patients with chronic musculoskeletal pain. Methods: This trial, conducted at a single center, follows a parallel, three-arm design with randomization and sham control. 90 hDKF patients with chronic musculoskeletal pain will be assigned randomly to three groups (acupuncture, sham acupuncture, and waiting-list control) in a 1:1:1 ratio. The acupuncture and sham acupuncture groups will undergo 24 treatment sessions over eight weeks, while the waiting-list control group will receive no acupuncture. The primary outcome measures changes in the Numeric Rating Scale (NRS) score from baseline at the end of treatment, with secondary outcomes including the Edmonton Symptom Assessment System (revised version) (ESAS-r), Palliative care Outcome Scale (rental) (POS-renal), and hospital anxiety and depression scale (HADS). Adverse events will be recorded throughout the study, and all randomized patients will be included in the intention-to-treat analysis. Discussion: The outcomes of this research aim to advance the systematic management of chronic musculoskeletal pain in HDKF patients through non-pharmacological interventions. Moreover, it will contribute insights into personalized treatment strategies, integrating individual expectations and genetic biomarkers to provide "precision" acupuncture for HDKF patients experiencing chronic musculoskeletal pain. Trial Registration: The trial registration number is ChiCTR2400080488. This trial was prospectively registered on 30 January 2024 in the Chinese Clinical Trial Registry.