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

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

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.

Study Overview

• Status: Completed
• 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

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6 weeks; Microdiscectomy was done at 6 weeks of starting symptoms	Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms; Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms
Active Comparator: 3 months; Microdiscectomy was done at 3 months of starting symptoms	Procedure: Lumbar Microdiscectomy at 3 months of symptoms; Microscope assisted lumbar discectomy done at 3 months of starting symptoms
Active Comparator: 6 months; Microdiscectomy was done at 6 months of starting symptoms	Procedure: Lumbar Microdiscectomy at 6 months of symptoms; Microscope assisted lumbar discectomy done at 6 months of starting symptoms

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

Collaborators and Investigators

• Sponsor: Hawler Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2016
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Outcomes; Duration of symptoms; Lumbar Microdiscectomy; Oswestry disability index; Roland-Morris Questionnaire
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: HMU/Sherwan11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No