Status:
UNKNOWN
Acupuncture for Lumbar Spinal Stenosis
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief 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).
Eligibility Criteria
Inclusion
- 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;
- Volunteer to participate the trial and provide written informed consent.
Exclusion
- 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;
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06102798
Start Date
November 14 2023
End Date
December 30 2025
Last Update
January 11 2024
Active Locations (1)
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1
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China