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

H

Hawler Medical University

Status

Completed

Conditions

Lumbar Disc Herniation

Treatments

Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms
Procedure: Lumbar Microdiscectomy at 6 months of symptoms
Procedure: Lumbar Microdiscectomy at 3 months of symptoms

Study type

Interventional

Funder types

Other

Identifiers

NCT04538027
HMU/Sherwan11

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

19 to 47 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 3 patient groups

6 weeks
Active Comparator group
Description:
Microdiscectomy was done at 6 weeks of starting symptoms
Treatment:
Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms
3 months
Active Comparator group
Description:
Microdiscectomy was done at 3 months of starting symptoms
Treatment:
Procedure: Lumbar Microdiscectomy at 3 months of symptoms
6 months
Active Comparator group
Description:
Microdiscectomy was done at 6 months of starting symptoms
Treatment:
Procedure: Lumbar Microdiscectomy at 6 months of symptoms

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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