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

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: Lumbar Microdiscectomy at 6 months of symptoms; Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms; Procedure: Lumbar Microdiscectomy at 3 months of symptoms

• Registration Number: NCT04538027
• Lead Sponsor: Hawler Medical University

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.

Study Timeline

• Study Start: 2016-01-03
• Primary Completion: 2020-02-15
• Study Completion: 2020-02-20
• Study First Submitted: 2020-08-25
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 months	Lumbar Microdiscectomy at 6 months of symptoms	Microdiscectomy was done at 6 months of starting symptoms
6 weeks	Lumbar Microdiscectomy at 6 weeks of symptoms	Microdiscectomy was done at 6 weeks of starting symptoms
3 months	Lumbar Microdiscectomy at 3 months of symptoms	Microdiscectomy was done at 3 months of starting symptoms

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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