Status:
COMPLETED
Efficacy of Acupuncture for Lumbar Spinal Stenosis
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Lumbar Spinal Stenosis
Intermittent Claudication
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina secondary to degenera...
Eligibility Criteria
Inclusion
- Meet the requirements for a clinical diagnosis of DLSS combined with a MRI- or computed tomography (CT)-based radiological diagnosis of central sagittal diameter stenosis of the lumbar spinal canal;
- Have neurogenic intermittent claudication (IC) characterized by progressive pain, numbness, weakness, and tingling of the buttocks and/or legs when standing or walking or with extension of the back, which are relieved upon sitting, lying down, or bending forward \[22\]; they must always walk in flexion or hunchback posture;
- Have pain of an intensity ≥4 in the buttocks and/or legs when walking, standing, or extending the back, as measured using the Numerical Rating Scale (NRS);
- Have pain in the buttock and/or leg that is more severe than their pain in the lower back;
- Have a Roland-Morris score of at least 7;
- Have received a MRI or CT scan within 1 year that showed the anterior posterior diameter of the canal was ≤12 mm;
- Are aged 50-80 years;
- Have provided signed consent and exhibit willingness to participate in the trial.
Exclusion
- Congenital stenosis of the vertebral canal, indications of surgery for DLSS (e.g., segmental muscular atrophy, bowel and bladder disturbances), spinal instability requiring surgery, lumbar tuberculosis, lumbar metastatic carcinoma, or vertebral body/vertebral stenosis segment compression fracture;
- Severe vascular, pulmonary, or coronary artery disease with limited lower extremities motility;
- Clinical comorbidities that could interfere with the collection of data related to pain and walking function such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, and dementia;
- Cognitive impairment, such that they are unable to understand the content of the assessment scales or provide accurate data;
- A history of lumbar surgery;
- Plans to become pregnant within 12 months or are already pregnant;
- Received acupuncture treatments for DLSS within the previous 30 days;
- Neurogenic IC mainly manifesting as numbness, weakness, or paraesthesia of the lower extremities instead of pain.
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03784729
Start Date
March 25 2019
End Date
March 18 2022
Last Update
August 20 2025
Active Locations (1)
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1
Guang An Men Hospital
Beijing, China, 100053