Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy
Primary Purpose
Lumbar Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumbar Microdiscectomy at 6 weeks of symptoms
Lumbar Microdiscectomy at 3 months of symptoms
Lumbar Microdiscectomy at 6 months of symptoms
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Duration of symptoms, Outcomes, Lumbar Microdiscectomy, Oswestry disability index, Roland-Morris Questionnaire
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
6 weeks
3 months
6 months
Arm Description
Microdiscectomy was done at 6 weeks of starting symptoms
Microdiscectomy was done at 3 months of starting symptoms
Microdiscectomy was done at 6 months of starting symptoms
Outcomes
Primary Outcome Measures
Oswestry disability index
Primary outcome measure for functional disability, the higher score is better function
Roland-Morris Questionnaire
Primary outcome measure for functional disability, the higher score is worse function
Secondary Outcome Measures
Visual analogue scale
Secondary outcome measure for back pain and leg pain, the higher score is more pain and bad results
Length of hospital stay
Secondary outcome measure of how many days patient remains in the hospital after operation
Return to daily activities
Secondary outcome measure of time patient needed to return to daily activities
Full Information
NCT ID
NCT04538027
First Posted
August 25, 2020
Last Updated
September 1, 2020
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04538027
Brief Title
Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy
Official Title
Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2016 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Duration of symptoms, Outcomes, Lumbar Microdiscectomy, Oswestry disability index, Roland-Morris Questionnaire
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 weeks
Arm Type
Active Comparator
Arm Description
Microdiscectomy was done at 6 weeks of starting symptoms
Arm Title
3 months
Arm Type
Active Comparator
Arm Description
Microdiscectomy was done at 3 months of starting symptoms
Arm Title
6 months
Arm Type
Active Comparator
Arm Description
Microdiscectomy was done at 6 months of starting symptoms
Intervention Type
Procedure
Intervention Name(s)
Lumbar Microdiscectomy at 6 weeks of symptoms
Intervention Description
Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms
Intervention Type
Procedure
Intervention Name(s)
Lumbar Microdiscectomy at 3 months of symptoms
Intervention Description
Microscope assisted lumbar discectomy done at 3 months of starting symptoms
Intervention Type
Procedure
Intervention Name(s)
Lumbar Microdiscectomy at 6 months of symptoms
Intervention Description
Microscope assisted lumbar discectomy done at 6 months of starting symptoms
Primary Outcome Measure Information:
Title
Oswestry disability index
Description
Primary outcome measure for functional disability, the higher score is better function
Time Frame
Oswestry disability index was measured the functional disability at 2 weeks
Title
Roland-Morris Questionnaire
Description
Primary outcome measure for functional disability, the higher score is worse function
Time Frame
Roland-Morris Questionnaire was measured the functional disability at 2 weeks
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Secondary outcome measure for back pain and leg pain, the higher score is more pain and bad results
Time Frame
Visual analogue scale was measured at 2 weeks
Title
Length of hospital stay
Description
Secondary outcome measure of how many days patient remains in the hospital after operation
Time Frame
Measuring the days of postoperative hospital stay immediately after the surgery
Title
Return to daily activities
Description
Secondary outcome measure of time patient needed to return to daily activities
Time Frame
Measuring the time needed t return to daily activities immediately after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy
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