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Acupuncture for Lumbar Spinal Stenosis

China420 participantsStarted 2023-11-14

Plain-language summary

The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS).

Who can participate

Age range50 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Meet the diagnosis criteria of LSS;
✓. Aged between 50-80 years;
✓. Neurogenic claudication (NC) for more than 3 months;
✓. Able to walk for at least 20 meters continually without device assistance, and forced to stopped walking out of NC within 30 mins in the meanwhile;
✓. The average pain of buttocks and/or legs scores≥4 on the Numerical Rating Scale (NRS) when walking, standing, or extending the back in the past week;
✓. More severe pain in the buttock and/or leg than in the lower back;
✓. Score at least 7 on Modified Roland-Morris Disability Questionnaire（RMDQ）;
✓. Central sagittal diameter stenosis of lumbar spinal canal as manifested by MRI or CT scan;

Exclusion criteria

✕. Non-degenerative LSS, such as congenital, post-traumatic or spondylolisthesis LSS; operation indications, such as segmental muscular atrophy, bowel and bladder disfunction, and spinal instability; tuberculosis or tumor in the lumbar area; or multiple vertebral compression fracture or compression fracture in the segment of stenosis;
✕. Vascular claudication;
✕. Severe heart, pulmonary, liver and/or kidney diseases;
✕. Clinical comorbidities that may interfere with the assessment of pain intensity or walking ability, such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, severe diabetes, and severe hypertension etc;
✕. Unable to complete motorized treadmill test at the speed of 2km/h;
✕. Severe psychiatric disorder or cognitive impairment that prevent the understanding of the outcome evaluating questionnaires;
✕. A history of lumbar surgery;
✕. Have received acupuncture treatments in the previous 2 weeks;

What they're measuring

The proportion of participants who achieves at least 30% improvement in total walking distance from baseline.

Timeframe: Weeks 6 and 18

Trial details

NCT IDNCT06102798

SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Zhishun Liu, PhD

86-010-88002331 zhishunjournal@163.com

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials