Status:
ACTIVE_NOT_RECRUITING
TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis
Lead Sponsor:
Beijing University of Chinese Medicine
Conditions:
Degenerative Lumbar Spinal Stenosis
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
Lumbar degenerative disease is a common disease develops into degenerative lumbar spinal stenosis(DLSS)in the elderly and eventually. The long course of disease and other characteristics determine tha...
Detailed Description
Under the guidance of TCM holistic view and syndrome differentiation views, the treatment group invented the concept of treating with tendon instead of bone and miscellaneous combination, and initiall...
Eligibility Criteria
Inclusion
- Diagnostic of Degenerative Lumbar Spinal Stenosis.
- Males and females aged between 40 and 85.
- Low back pain and leg pain accompanied by typical neurogenic intermittent claudication symptoms, lasting ≧3 months.
- The effect of 3 months conservative treatment(Oral painkillers + any 1 physical therapy) was not ideal(Less than 50% relief from pain or functional limitations).
- Having any of the following surgical indications: 1.Low back and leg pain after exercise, affecting life and work (the patient felt seriously affecting life and work);2. Progressive claudication(Continuous walking distance is less than 100m),or standing time is decreasing(Standing time at a time reduced to 50% of the onset);3. Those with obvious neurological defects(Suddenly appear the paresthesia of the distribution area of spinal nerve, such as numbness, acid bilges, acupuncture feeling, limb hair cool).
- The patient refused surgical treatment.
- Willing to participate in this study, and signed the informed consent.
Exclusion
- Patients with vasogenic intermittent claudication.
- Patients with other bone and joint diseases, including spinal vertebra fracture, lumbar tuberculosis, spinal tumor and other lesions, or rheumatism, rheumatoid arthritis.
- Patients with hematopoietic system(anemia,aplastic anemia), cardiocerebral vascular system(History of cerebral hemorrhage, Serious cardiovascular disease), endocrine system(Poor glycemic control in diabetes, such as postprandial blood glucose over 12mmol/L) and other serious primary diseases, tumors and psychosis.
- Patients with scoliosis \>15° or disc instability (rotation \>10° or translation \>4mm).
- Patients after minimally invasive surgery and open surgery.
- Patients who received an epidural steroid injection within 6 months.
- The patient is allergic to Traditional Chinese medicine, history of skin allergy and allergic constitution.
- The treatment site has subcutaneous unknown lump, the skin is red and swollen broken ulceration inflammation or skin lesions, etc.
- Patients with severe cauda equina syndrome.
- Women who are menstruating, pregnant or breastfeeding.
- Patients with strong preferences for treatment, disobedience to random assignment, and poor compliance.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05273346
Start Date
September 1 2022
End Date
December 30 2025
Last Update
August 9 2024
Active Locations (1)
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1
Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
Beijing, Beijing Municipality, China