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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

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

19 Years - 47 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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