Clinical efficacy of Linggui Tanxue acupuncture combined with extracorporeal shock wave therapy for piriformis syndrome: a prospective comparative clinical study.

OBJECTIVE: To evaluate the short-term clinical efficacy and safety of Linggui Tanxue acupuncture combined with extracorporeal shock wave therapy (ESWT) in patients with piriformis syndrome (PS). METHODS: Sixty patients with PS aged 35 to 45 years were prospectively allocated using a random-number table into a control group receiving ESWT alone and a combined-treatment group receiving Linggui Tanxue acupuncture followed by ESWT, with 30 patients in each group. The treatment course lasted 2 weeks. Visual analogue scale (VAS) pain scores, musculoskeletal ultrasound (MSUS)-measured piriformis muscle thickness, clinical efficacy category, and adverse events were evaluated. Pain assessment and ultrasound measurement were performed by assessors blinded to treatment allocation. Because the study was not prospectively registered and no predefined statistical analysis plan or formal sample size calculation was established before initiation, the analysis should be interpreted as exploratory. RESULTS: Baseline sex distribution, age, disease duration, VAS scores, and piriformis muscle thickness were comparable between groups (all p > 0.05). After 2 weeks, both groups showed significant reductions in VAS scores and piriformis muscle thickness (both p < 0.001). The combined-treatment group showed significantly greater improvement than the ESWT-alone control group in the two continuous outcomes: post-treatment VAS score was lower in the combined-treatment group (1.44 ± 0.10 vs. 3.57 ± 0.17; mean difference, -2.12; 95% CI, -2.20 to -2.05; p < 0.001), and post-treatment piriformis thickness was also lower (9.04 ± 0.16 mm vs. 12.16 ± 0.25 mm; mean difference, -3.13 mm; 95% CI, -3.23 to -3.02; p < 0.001). The combined-treatment group also had a significantly higher total effective rate than the control group (86.7% vs. 46.7%; Fisher exact p = 0.002), but this categorical outcome was considered supportive and should be interpreted cautiously. No serious adverse events occurred. CONCLUSION: Linggui Tanxue acupuncture combined with ESWT may provide greater short-term pain relief and greater ultrasound-measured improvement in piriformis muscle thickness than ESWT alone in patients with PS. The findings are encouraging but not definitive because of the absence of prospective registration, lack of a predefined statistical analysis plan, lack of formal sample size calculation, and the short 2-week follow-up period. Larger prospectively registered multicenter studies with predefined statistical analysis plans, formal sample size calculations, and longer follow-up are warranted.