Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk: A Randomized Clinical Trial

This multicenter, randomized, sham-controlled trial investigated the efficacy of acupuncture in the treatment of chronic sciatica caused by lumbar disk herniation. Sciatica is a condition characterized by radiating pain along the sciatic nerve, frequently associated with low back pain, and represents a significant public health problem due to the severe pain and prolonged disability it causes. Approximately 85% of sciatica cases are caused by lumbar disk herniation with lumbosacral nerve root compression and resulting inflammation. Although many patients recover spontaneously or with conservative treatments, 45% of patients with chronic sciatica do not show significant improvement after one year, and 34% report chronic pain beyond two years.

The study was conducted at 6 tertiary hospitals in China, recruiting 216 patients with chronic unilateral sciatica due to herniated disk for more than 3 months and moderate to severe pain intensity (≥40 mm on the 100-mm visual analog scale). Participants were randomized into two groups: real acupuncture (n=108) and sham acupuncture (n=108). The treatment protocol was based on expert consensus and included 10 sessions over 4 weeks, with a decreasing frequency from 3 sessions per week in the first two weeks to 2 sessions in the remaining weeks. The acupuncture group received needling at traditional bilateral points dachangshu (BL-25) and guanyuanshu (BL-26) in the lumbar region, in addition to specific points on the affected side based on pain distribution: for lateral lower-limb pain, huantiao (GB-30), fengshi (GB-31), xiyangguan (GB-33), yanglingquan (GB-34), and xuanzhong (GB-39) were used; for posterior pain, zhibian (BL-36), chengfu (BL-40), weizhong (BL-54), chengshan (BL-57), and kunlun (BL-60) were used.

Needles were inserted to specific depths and manipulated to obtain the deqi sensation, which was expected to radiate to the affected leg. The sham group received needling at non-acupoints distant from the meridians, using non-penetrating blunt needles, except at one point where a conventional needle without manipulation was used. The co-primary outcomes were changes in the visual analog scale (VAS) for leg pain and the Oswestry Disability Index (ODI) from baseline to the end of 4 weeks. Results showed statistically significant and clinically important differences between the groups.

The VAS for leg pain decreased by 30.8 mm in the acupuncture group versus 14.9 mm in the sham group at week 4 (mean difference -16.0; 95% CI -21.3 to -10.6; P<0.001). The ODI decreased by 13.0 points in the acupuncture group versus 4.9 points in the sham group at week 4 (mean difference -8.1; 95% CI -11.1 to -5.1; P<0.001). Notably, between-group differences became apparent as early as week 2 and persisted through week 52, demonstrating sustained long-term benefits. Secondary outcomes also favored acupuncture, including back pain, frequency and bothersomeness of sciatica (SFBI), physical quality of life (SF-36), and patient global assessment.

Safety was excellent, with mild and self-limited adverse events (mainly subcutaneous hematoma and minor bleeding) in 24.1% of patients in the acupuncture group versus 4.6% in the sham group, with no serious adverse events. Blinding was effectively maintained throughout the study. The clinical implications are significant, as both the differences in pain (16 mm) and disability (8.1 points) exceeded the prespecified minimum clinically important differences of 15 mm and 7 points, respectively. This suggests that acupuncture offers clinically meaningful benefits for patients with chronic sciatica due to herniated disk.