Lumbar Disc Herniation
Conditions
Keywords
Duration of symptoms, Outcomes, Lumbar Microdiscectomy, Oswestry disability index, Roland-Morris Questionnaire
Brief summary
97 patients in 3 randomized groups were treated by Microdiscectomy for lumbar disc herniation; Group A was operated at 6 weeks of symptoms, Group B at 3 months and group C at 6 months. These patients were followed for 3 years for the clinical and functional outcomes.
Detailed description
150 patients were enrolled in this study and only 97 patients were finally analyzed for primary outcomes measures of Oswestry disability index and Roland-Morris Questionnaire and secondary outcome measures of Visual analogue scale for back pain and leg pain as well as length of hospital stay and time to return for daily activities. Assessments done at different periods of 2 weeks, 3 months, 6 months, 1year, 2 years and 3 years.
Interventions
PROCEDURELumbar Microdiscectomy at 6 weeks of symptoms
Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms
PROCEDURELumbar Microdiscectomy at 3 months of symptoms
Microscope assisted lumbar discectomy done at 3 months of starting symptoms
PROCEDURELumbar Microdiscectomy at 6 months of symptoms
Microscope assisted lumbar discectomy done at 6 months of starting symptoms
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 47 Years
Healthy volunteers
Yes
Inclusion criteria
* Age more than 18 years * Disc herniation of L3-4, L4-5 or L5-S1 * MRI showed disc protrusion or extrusion with nerve root compression corresponding to clinical features.
Exclusion criteria
* Spondylolysis or spondylolisthesis. * Spinal deformity like scoliosis. * Previous spinal surgery or infection. * Cauda equina syndrome. * Lumbar segmental instability on dynamic radiograph: translation more than 3 mm or change in angulation more than 10 degrees * Smoking * Diabetes Mellitus * Disc herniation other than levels L3-L4, L4-L5 and L5-S1 * More than single level disc hernaition. * Body mass index 30 or more than 30 * Contained disc herniation by MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry disability index | Oswestry disability index was measured the functional disability at 2 weeks | Primary outcome measure for functional disability, the higher score is better function |
| Roland-Morris Questionnaire | Roland-Morris Questionnaire was measured the functional disability at 2 weeks | Primary outcome measure for functional disability, the higher score is worse function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | Visual analogue scale was measured at 2 weeks | Secondary outcome measure for back pain and leg pain, the higher score is more pain and bad results |
| Length of hospital stay | Measuring the days of postoperative hospital stay immediately after the surgery | Secondary outcome measure of how many days patient remains in the hospital after operation |
| Return to daily activities | Measuring the time needed t return to daily activities immediately after the surgery | Secondary outcome measure of time patient needed to return to daily activities |
Outcome results
None listed