BMJ open · 2026
Effectiveness and safety of electroacupuncture as an adjunct to guideline-based usual care for acute lumbar disc herniation: a multicentre, randomised, sham-controlled trial protocol.
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Yan Zheng, You Peijie, Lai Qilong, Zhu Yicheng, Xu Suliang, Shen Xiao, Wang Yibo, Sun Yitao, Xia Jiao, Liu Guanhong, Liu Jingtao, Gong Guanyi
Аннотация
INTRODUCTION: Acute lumbar disc herniation (LDH) is a major cause of low back pain and lumbosacral radiculopathy. Although guideline-based conservative management (eg, non-steroidal anti-inflammatory drugs and physical therapy) is recommended as first-line care for most patients, pain relief and functional recovery are often incomplete and medication-related adverse effects can limit adherence. Electroacupuncture (EA) is widely used as an adjunctive therapy for LDH and may provide analgesic and functional benefits through neuromodulation. However, high-quality sham-controlled evidence in acute/subacute LDH remains insufficient. This trial aims to evaluate the effectiveness and safety of EA added to usual care in acute/subacute LDH.
METHODS AND ANALYSIS: This multicentre, parallel-group, randomised, sham-controlled trial will recruit 180 participants aged 18–65 years with acute/subacute LDH confirmed by lumbar CT or MRI (symptom duration 2–6 weeks) and baseline pain Visual Analogue Scale (VAS) score ≥4/10 from four tertiary hospitals in China. Participants will be randomised 1:1 using stratified variable block randomisation (strata: centre, baseline VAS ≤6 vs >6, age <45 vs ≥45) with concealed allocation. Both groups will receive usual care (celecoxib 100 mg twice daily plus physical therapy three times weekly). Rescue tramadol hydrochloride 50 mg will be permitted when VAS is ≥7, subject to a minimum 8-hour dosing interval, a maximum daily dose of 300 mg and a maximum continuous duration of 48 hours. The EA group will additionally receive EA at bilateral BL23, BL25 and EX-B2 with 2/100 Hz alternating stimulation (0.5–2 mA), 30 min per session, three sessions per week for 6 weeks (18 sessions). The sham group will receive non-penetrating Park sham needles with identical procedures but no insertion and no electrical output. Outcome assessors and statisticians will be blinded. The primary outcome is change in average low back/leg pain VAS from baseline to week 6. Secondary outcomes include Oswestry Disability Index, SF-36, MRI-based herniation volume and T2 signal intensity at week 6, Patient Global Impression of Change, rescue analgesic use and adverse events. Follow-up will continue to 6 months. Primary analysis will follow the intention-to-treat principle using linear mixed-effects models with multiple imputation for missing data.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from the ethics committees of all four participating centres: the Research Ethics Committee of Suzhou Hospital of Traditional Chinese Medicine (2025-040), the Ethics Review Committee of Changshu Hospital of Traditional Chinese Medicine (CZYLS-2026005), the Ethics Committee of Sichuan Provincial Orthopaedic Hospital (KY2026-006-01) and the Medical Ethics Committee of Suqian Hospital of Traditional Chinese Medicine (2025120009).
TRIAL REGISTRATION NUMBER: ITMCTR2025002522.
METHODS AND ANALYSIS: This multicentre, parallel-group, randomised, sham-controlled trial will recruit 180 participants aged 18–65 years with acute/subacute LDH confirmed by lumbar CT or MRI (symptom duration 2–6 weeks) and baseline pain Visual Analogue Scale (VAS) score ≥4/10 from four tertiary hospitals in China. Participants will be randomised 1:1 using stratified variable block randomisation (strata: centre, baseline VAS ≤6 vs >6, age <45 vs ≥45) with concealed allocation. Both groups will receive usual care (celecoxib 100 mg twice daily plus physical therapy three times weekly). Rescue tramadol hydrochloride 50 mg will be permitted when VAS is ≥7, subject to a minimum 8-hour dosing interval, a maximum daily dose of 300 mg and a maximum continuous duration of 48 hours. The EA group will additionally receive EA at bilateral BL23, BL25 and EX-B2 with 2/100 Hz alternating stimulation (0.5–2 mA), 30 min per session, three sessions per week for 6 weeks (18 sessions). The sham group will receive non-penetrating Park sham needles with identical procedures but no insertion and no electrical output. Outcome assessors and statisticians will be blinded. The primary outcome is change in average low back/leg pain VAS from baseline to week 6. Secondary outcomes include Oswestry Disability Index, SF-36, MRI-based herniation volume and T2 signal intensity at week 6, Patient Global Impression of Change, rescue analgesic use and adverse events. Follow-up will continue to 6 months. Primary analysis will follow the intention-to-treat principle using linear mixed-effects models with multiple imputation for missing data.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from the ethics committees of all four participating centres: the Research Ethics Committee of Suzhou Hospital of Traditional Chinese Medicine (2025-040), the Ethics Review Committee of Changshu Hospital of Traditional Chinese Medicine (CZYLS-2026005), the Ethics Committee of Sichuan Provincial Orthopaedic Hospital (KY2026-006-01) and the Medical Ethics Committee of Suqian Hospital of Traditional Chinese Medicine (2025120009).
TRIAL REGISTRATION NUMBER: ITMCTR2025002522.