The Effectiveness of Fu’s Subcutaneous Needling for Residual Pain After Percutaneous Vertebral Augmentation in Osteoporotic Vertebral Compression Fractures: A Randomized Clinical Trial Protocol

Background: Osteoporotic vertebral compression fractures (OVCFs) represent a significant cause of pain and functional disability in older adults. While vertebroplasty effectively alleviates acute pain and restores vertebral stability, a substantial proportion of patients experience persistent post-vertebroplasty residual pain. Emerging evidence indicates this pain is closely associated with myofascial injury and muscular dysfunction around the affected vertebrae. Fu's subcutaneous needling (FSN) has demonstrated efficacy in managing musculoskeletal pain; however, its safety and efficacy for post-vertebroplasty residual pain in OVCF patients remain understudied. This randomized controlled trial aims to evaluate the clinical efficacy of FSN in managing persistent post-procedural pain among patients following vertebroplasty, while exploring its underpinnings. Methods: This single-center, parallel-group, randomized controlled trial (RCT) will enroll 60 patients with osteoporotic vertebral compression fractures (OVCF) experiencing residual pain after vertebroplasty. Eligible participants will be randomly allocated in a 1:1 ratio to either Fu's subcutaneous needling (FSN) plus oral meloxicam therapy or meloxicam monotherapy. FSN determined three insertion points based on the patient's condition: (A) 2 cm lateral to the affected vertebra; (B) intersection of the umbilical plane and posterior axillary line; (C) midpoint of the posterior lower leg (between popliteal fossa and heel). Interventions will be administered once daily over seven consecutive days. The primary endpoint is the change from baseline in the Oswestry Disability Index (ODI) score at treatment completion. Secondary outcomes include: (i) Pain intensity (Visual Analog Scale, VAS); (ii) Lumbar function (Japanese Orthopaedic Association [JOA] score); (iii) Regional temperature differentials (infrared thermography); (iv) Serum inflammatory markers (IL-1β, IL-6, TNF-α); and (v) Incidence of treatment-emergent adverse events. Data will undergo intention-to-treat analysis with two-sided statistical testing (α=0.05; 95% confidence intervals).