Status:
UNKNOWN
Degenerative Lumbar Stenosis Conservative Treatment
Lead Sponsor:
Sutherland Medical Center
Conditions:
Spinal Stenosis Lumbar
Spinal Canal Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injec...
Detailed Description
BACKGROUND: Degenerative Lumbar Spinal Stenosis (DLSS) is a serious health problem for patients over 65 years of age. It is assumed that in the United States alone, it affects about 200 thousand patie...
Eligibility Criteria
Inclusion
- Clinical signs of lumbar spinal stenosis
- Radiological signs of lumbar spinal stenosis confirmed by MRI
- No contraindications to steroid therapy or spinal epidural injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- Mental state allowing cooperation during manual therapy
- An adult who consents to participate in the study
- No previous surgery or spinal epidural injections
Exclusion
- The presence of serious neurological deficits
- Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection
- Contraindications to steroid therapy or spinal injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- Previous surgery or spinal epidural injections of lumbar spine
- Mental state preventing cooperation during manual therapy
- Lack of consent to participate in the study
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04492774
Start Date
July 1 2020
End Date
December 31 2022
Last Update
March 11 2021
Active Locations (1)
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1
Sutherland Medical Center
Warsaw, Masovian Voivodeship, Poland, 04-036