Lumbar Spinal Canal Stenosis Clinical Trial
Official title:
Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression
Verified date | September 2014 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Cairo University |
Study type | Interventional |
To evaluate a new endoscopic technique for lumbar spinal canal decompression.
Status | Completed |
Enrollment | 104 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit 2. Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included) 3. Failure of 3 months conservative treatment 4. Grade I degenerative spondylolisthesis and degenerative scoliosis Exclusion Criteria: 1. Segmental Instability 2. Lytic Spondylolisthesis 2- Predominant low back pain |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index | Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling | 24 months | No |
Primary | Modified Macnab criteria | patient satisfaction, the need for medications, ability to return to activity | 24 months | No |
Secondary | Time for ambulation | postoperative time required to start ambulation | 72 hours | No |
Secondary | Time for hospitalization | postoperative hospital stay till discharge | 72 hours | No |
Secondary | VAS for back pain | Pain intensity on scale from 0-10 | 72 hours | No |