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Completed

NCT Number: NCT04538027

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

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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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

19 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Microdiscectomy at 6 weeks of symptoms

Procedure

Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms

Lumbar Microdiscectomy at 3 months of symptoms

Procedure

Microscope assisted lumbar discectomy done at 3 months of starting symptoms

Lumbar Microdiscectomy at 6 months of symptoms

Procedure

Microscope assisted lumbar discectomy done at 6 months of starting symptoms

Primary outcomes

  1. Oswestry disability index

    Time frame: Oswestry disability index was measured the functional disability at 2 weeks

    Primary outcome measure for functional disability, the higher score is better function

  2. Roland-Morris Questionnaire

    Time frame: Roland-Morris Questionnaire was measured the functional disability at 2 weeks

    Primary outcome measure for functional disability, the higher score is worse function

Secondary outcomes

  1. Visual analogue scale

    Time frame: Visual analogue scale was measured at 2 weeks

    Secondary outcome measure for back pain and leg pain, the higher score is more pain and bad results

  2. Length of hospital stay

    Time frame: Measuring the days of postoperative hospital stay immediately after the surgery

    Secondary outcome measure of how many days patient remains in the hospital after operation

  3. Return to daily activities

    Time frame: Measuring the time needed t return to daily activities immediately after the surgery

    Secondary outcome measure of time patient needed to return to daily activities

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 3, 2020
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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