A prospective, randomized, sham-controlled trial is currently underway at Putuo Hospital, Shanghai University of Traditional Chinese Medicine, to investigate the efficacy and safety of acupuncture for managing chronic musculoskeletal pain in patients with hemodialysis-dependent kidney failure (HDKF). The study, registered with the Chinese Clinical Trial Registry (ChiCTR2400080488), aims to address the significant unmet need for effective pain management in this population, where chronic pain affects a substantial proportion of individuals and often goes inadequately treated.
Trial Design and Methodology
The trial employs a three-arm, parallel-group design, randomly assigning eligible HDKF patients with chronic musculoskeletal pain to either an acupuncture group, a sham acupuncture group, or a waiting-list control group in a 1:1:1 ratio. The study spans 13 weeks, including a 1-week baseline, an 8-week treatment phase, and a 4-week follow-up period. Acupuncture sessions are administered three times per week, each lasting 30 minutes. The primary outcome measure is the change in Numeric Rating Scale (NRS) scores from baseline to weeks 4, 8, and 12.
Acupuncture Intervention
The acupuncture point selection follows a semi-fixed standardized scheme, incorporating acupoints such as bilateral Hegu (LI-4), Neiguan (PC-6), Zusanli (ST-36), and Sanyinjiao (SP-6). Additional points are selected based on the patient’s specific pain sites. Disposable stainless steel filiform needles are inserted through adhesive pads at a depth of 10 to 35 mm, with manipulation performed until the patient experiences a sensation of soreness, numbness, distension, or heaviness (Deqi).
In the sham acupuncture group, a specially designed flat-tipped needle is used to simulate acupuncture without penetrating the skin. Participants in the waiting-list control group receive only routine hemodialysis, nursing education, and symptomatic supportive treatment.
Outcome Measures and Data Analysis
Primary outcome is assessed using the difference in NRS scores from baseline at 0, 4, 8, and 12 weeks. Secondary outcome measures include pain relief rate, changes in NRS scores, and assessments using the Edmonton Symptom Assessment System (ESAS-r), Palliative care Outcome Scale (POS-renal), and Hospital Anxiety and Depression Scale (HADS). Data analysis will be conducted using SPSS 26.0, with statistical significance set at α=0.05.
Significance and Implications
Chronic pain is a prevalent issue among HDKF patients, with musculoskeletal pain affecting 57% of individuals. Traditional pain management strategies often prove ineffective, leaving many patients dissatisfied with the relief provided. This trial seeks to provide rigorous evidence for the use of acupuncture as a non-pharmacological intervention for chronic musculoskeletal pain in HDKF patients, potentially reducing reliance on opioid medications and improving their quality of life. The study aligns with the HOPE Alliance’s emphasis on holistic, “people-centered” pain management models and personalized treatment strategies.
