Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy

Study Overview
=================
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.

Official Title
-----------------
Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy: a Randomized Controlled Trial

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms
* Procedure: Lumbar Microdiscectomy at 3 months of symptoms
* Procedure: Lumbar Microdiscectomy at 6 months of symptoms


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 47 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 weeks<br>Microdiscectomy was done at 6 weeks of starting symptoms | Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms<br>* Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms<br>|
| Active Comparator: 3 months<br>Microdiscectomy was done at 3 months of starting symptoms | Procedure: Lumbar Microdiscectomy at 3 months of symptoms<br>* Microscope assisted lumbar discectomy done at 3 months of starting symptoms<br>|
| Active Comparator: 6 months<br>Microdiscectomy was done at 6 months of starting symptoms | Procedure: Lumbar Microdiscectomy at 6 months of symptoms<br>* Microscope assisted lumbar discectomy done at 6 months of starting symptoms<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry disability index | Primary outcome measure for functional disability, the higher score is better function | Oswestry disability index was measured the functional disability at 2 weeks | 
| Roland-Morris Questionnaire | Primary outcome measure for functional disability, the higher score is worse function | Roland-Morris Questionnaire was measured the functional disability at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Secondary outcome measure for back pain and leg pain, the higher score is more pain and bad results | Visual analogue scale was measured at 2 weeks | 
| Length of hospital stay | Secondary outcome measure of how many days patient remains in the hospital after operation | Measuring the days of postoperative hospital stay immediately after the surgery | 
| Return to daily activities | Secondary outcome measure of time patient needed to return to daily activities | Measuring the time needed t return to daily activities immediately after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duration of symptoms, Outcomes, Lumbar Microdiscectomy, Oswestry disability index, Roland-Morris Questionnaire