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CompletedNCT04538027Updated Sep 3, 2020

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

An interventional study of Lumbar Microdiscectomy at 6 weeks of symptoms and Lumbar Microdiscectomy at 3 months of symptoms in Lumbar Disc Herniation, sponsored by Hawler Medical University. Completed. Open to participants aged 19 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled Jan 2016, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
19 Years to 47 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lumbar Disc Herniation

Keywords

  • Duration of symptoms
  • Outcomes
  • Lumbar Microdiscectomy
  • Oswestry disability index
  • Roland-Morris Questionnaire
03

In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's enrollment of 150 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

Hawler Medical University is the lead sponsor of 56 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 47 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    6 weeks

    Microdiscectomy was done at 6 weeks of starting symptoms

    Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms

  • Active comparator
    3 months

    Microdiscectomy was done at 3 months of starting symptoms

    Procedure: Lumbar Microdiscectomy at 3 months of symptoms

  • Active comparator
    6 months

    Microdiscectomy was done at 6 months of starting symptoms

    Procedure: Lumbar Microdiscectomy at 6 months of symptoms

Interventions

  • ProcedureLumbar Microdiscectomy at 6 weeks of symptoms

    Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms

  • ProcedureLumbar Microdiscectomy at 3 months of symptoms

    Microscope assisted lumbar discectomy done at 3 months of starting symptoms

  • ProcedureLumbar Microdiscectomy at 6 months of symptoms

    Microscope assisted lumbar discectomy done at 6 months of starting symptoms

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04538027
Lead sponsor
Hawler Medical University
Responsible party
Sherwan Ahmed Ali Hamawandi (Assistant professor of orthopedic surgery, Hawler Medical University) — Principal investigator
First posted
Sep 3, 2020
Start date
Jan 3, 2016
Primary completion
Feb 15, 2020
Completion
Feb 20, 2020
Last update
Sep 3, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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