Acupuncture for treating symptoms of lumbar spinal stenosis

The Efficacy and Safety of Acupuncture in Relieving Neurogenic Claudication Among Patients With Lumbar Spinal Stenosis: a Randomized Controlled Trial

This study is testing whether acupuncture can help people aged 50-80 with lumbar spinal stenosis feel less pain and improve their ability to walk and stand.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06102798 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50-80 with a diagnosis of degenerative lumbar spinal stenosis and significant neurogenic claudication symptoms.

Not a fit: Patients with non-degenerative forms of lumbar spinal stenosis or those requiring surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive treatment option for patients suffering from debilitating symptoms of lumbar spinal stenosis.

How similar studies have performed: Previous studies have shown promising results for acupuncture in managing chronic pain conditions, suggesting potential success for this approach in treating lumbar spinal stenosis.

Eligibility criteria

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 this trial is running

Beijing

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

Study contacts

• Study coordinator: Zhishun Liu, PhD

Conditions Lumbar Spinal Stenosis; Acupuncture; Neurogenic Claudication; Randomized controlled trial