Extracorporeal Radial Shock Wave Therapy Combined With Repetitive Transcranial Magnetic Stimulation for Nonspecific Low Back Pain: A Randomized Controlled Trial Protocol

OBJECTIVE: Nonspecific low back pain is extremely common, with clinical symptoms mainly characterized by pain and functional impairment. Moreover, pain can further induce anxiety, depression, and sleep disorders. Although there are many existing rehabilitation methods, their therapeutic effects are limited and the recurrence rate is high. Therefore, we plan to conduct a clinical efficacy evaluation of extracorporeal radial shock wave therapy combined with repetitive transcranial magnetic stimulation for nonspecific low back pain and also explore the potential therapeutic mechanisms. METHODS: This study employed a randomized, double-blind, parallel-controlled trial design (allocation ratio: 1:1:1:1). A total of 160 patients were enrolled and randomly assigned to four groups (n = 40 per group): Extracorporeal Shock Wave Therapy group (Active ESWT + Sham rTMS), Repetitive Transcranial Magnetic Stimulation group (Sham ESWT + Active rTMS), Combined Treatment group (Active ESWT + Active rTMS), Placebo group (Sham ESWT + Sham rTMS). Outcome assessments were performed at baseline and after 4 weeks of intervention, including the Visual Analog Scale (VAS), Short-Form McGill Pain Questionnaire (SF-MPQ), lumbar Range of Motion (ROM), Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAMA), Zung Self-Rating Depression Scale (SDS Index), multimodal magnetic resonance imaging (MRI), and inflammatory factors. All participants were followed up for 3 months. The primary outcome measure was the VAS score. Data were collected after treatment and subjected to statistical analysis. CONCLUSION: This study will verify the clinical intervention efficacy of ESWT combined with rTMS for nonspecific low back pain and explore the potential therapeutic mechanisms.