Acupuncture for treating symptoms of lumbar spinal stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of acupuncture in reducing neurogenic claudication symptoms in patients diagnosed with degenerative lumbar spinal stenosis. Participants aged 50-80 years who have experienced neurogenic claudication for over three months will receive either acupuncture or sham acupuncture. The study aims to assess improvements in pain levels and functional disability associated with walking and standing. The trial will utilize a randomized controlled design to ensure robust results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meet the diagnosis criteria of LSS;
2. Aged between 50-80 years;
3. Neurogenic claudication (NC) for more than 3 months;
4. 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;
5. 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;
6. More severe pain in the buttock and/or leg than in the lower back;
7. Score at least 7 on Modified Roland-Morris Disability Questionnaire（RMDQ）;
8. Central sagittal diameter stenosis of lumbar spinal canal as manifested by MRI or CT scan;
9. Volunteer to participate the trial and provide written informed consent.

Exclusion Criteria:

1. 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;
2. Vascular claudication;
3. Severe heart, pulmonary, liver and/or kidney diseases;
4. 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;
5. Unable to complete motorized treadmill test at the speed of 2km/h;
6. Severe psychiatric disorder or cognitive impairment that prevent the understanding of the outcome evaluating questionnaires;
7. A history of lumbar surgery;
8. Have received acupuncture treatments in the previous 2 weeks;

Where it's running

• Guang'anmen Hospital, China Academy of Chinese Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zhishun Liu, PhD
• Email: zhishunjournal@163.com
• Phone: 86-010-88002331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.