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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-03

Study Completion Date

2020-02-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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6 weeks

Microdiscectomy was done at 6 weeks of starting symptoms

Group Type ACTIVE_COMPARATOR

Lumbar Microdiscectomy at 6 weeks of symptoms

Intervention Type PROCEDURE

Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms

3 months

Microdiscectomy was done at 3 months of starting symptoms

Group Type ACTIVE_COMPARATOR

Lumbar Microdiscectomy at 3 months of symptoms

Intervention Type PROCEDURE

Microscope assisted lumbar discectomy done at 3 months of starting symptoms

6 months

Microdiscectomy was done at 6 months of starting symptoms

Group Type ACTIVE_COMPARATOR

Lumbar Microdiscectomy at 6 months of symptoms

Intervention Type PROCEDURE

Microscope assisted lumbar discectomy done at 6 months of starting symptoms

Interventions

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Lumbar Microdiscectomy at 6 weeks of symptoms

Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms

Intervention Type PROCEDURE

Lumbar Microdiscectomy at 3 months of symptoms

Microscope assisted lumbar discectomy done at 3 months of starting symptoms

Intervention Type PROCEDURE

Lumbar Microdiscectomy at 6 months of symptoms

Microscope assisted lumbar discectomy done at 6 months of starting symptoms

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

47 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes