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

Hawler Medical University150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Lumbar Disc Herniation

Interventions

Lumbar Microdiscectomy at 6 weeks of symptomsPROCEDURE

Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms

Lumbar Microdiscectomy at 3 months of symptomsPROCEDURE

Microscope assisted lumbar discectomy done at 3 months of starting symptoms

Lumbar Microdiscectomy at 6 months of symptomsPROCEDURE

Microscope assisted lumbar discectomy done at 6 months of starting symptoms

Eligibility

Sex: ALLMin age: 19 YearsMax age: 47 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Oswestry disability index

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

Roland-Morris Questionnaire

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 Outcomes

Visual analogue scale

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

Length of hospital stay

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

Return to daily activities

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

Data from ClinicalTrials.gov

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