Lumbar Disc HerniationNCT04538027
Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy
A study testing Lumbar Microdiscectomy at 6 weeks of symptoms, Lumbar Microdiscectomy at 3 months of symptoms and Lumbar Microdiscectomy at 6 months of symptoms in people with Lumbar Disc Herniation, run by Hawler Medical University.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 47 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Lumbar Microdiscectomy at 6 weeks of symptoms, Lumbar Microdiscectomy at 3 months of symptoms and Lumbar Microdiscectomy at 6 months of symptoms
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2016to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 47 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: 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.
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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Lumbar Microdiscectomy at 6 weeks of symptoms, Lumbar Microdiscectomy at 3 months of symptoms, Lumbar Microdiscectomy at 6 months of symptoms
- Keywords
- Duration of symptoms, Outcomes, Lumbar Microdiscectomy, Oswestry disability index, Roland-Morris Questionnaire
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Microdiscectomy at 6 weeks of symptomsProcedure or surgery
Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms
Lumbar Microdiscectomy at 3 months of symptomsProcedure or surgery
Microscope assisted lumbar discectomy done at 3 months of starting symptoms
Lumbar Microdiscectomy at 6 months of symptomsProcedure or surgery
Microscope assisted lumbar discectomy done at 6 months of starting symptoms
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks | Active comparator | Microdiscectomy was done at 6 weeks of starting symptoms Receives: Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms |
| 3 months | Active comparator | Microdiscectomy was done at 3 months of starting symptoms Receives: Procedure: Lumbar Microdiscectomy at 3 months of symptoms |
| 6 months | Active comparator | Microdiscectomy was done at 6 months of starting symptoms Receives: Procedure: Lumbar Microdiscectomy at 6 months of symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
Primary outcome measure for functional disability, the higher score is better function
Measured: 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
Measured: Roland-Morris Questionnaire was measured the functional disability at 2 weeks
Secondary outcomes (3)
Visual analogue scale
Secondary outcome measure for back pain and leg pain, the higher score is more pain and bad results
Measured: 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
Measured: 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
Measured: Measuring the time needed t return to daily activities immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start3 Jan 2016
- Primary completion15 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538027
- Sponsor's protocol ID
- HMU/Sherwan11
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04538027
- Acronym / sponsor ID
- HMU/Sherwan11
- Conditions
- Lumbar Disc Herniation
- Keywords
- Duration of symptoms, Outcomes, Lumbar Microdiscectomy, Oswestry disability index, Roland-Morris Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 weeks | Active comparator | Procedure: Lumbar Microdiscectomy at 6 weeks of symptomsMicrodiscectomy was done at 6 weeks of starting symptoms |
| 3 months | Active comparator | Procedure: Lumbar Microdiscectomy at 3 months of symptomsMicrodiscectomy was done at 3 months of starting symptoms |
| 6 months | Active comparator | Procedure: Lumbar Microdiscectomy at 6 months of symptomsMicrodiscectomy was done at 6 months of starting symptoms |
Who may qualify
- Ages
- 19 to 47 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Microdiscectomy at 6 weeks of symptomsMicroscope assisted lumbar discectomy done at 6 weeks of starting symptoms | Procedure or surgery | 6 weeks |
| Lumbar Microdiscectomy at 3 months of symptomsMicroscope assisted lumbar discectomy done at 3 months of starting symptoms | Procedure or surgery | 3 months |
| Lumbar Microdiscectomy at 6 months of symptomsMicroscope assisted lumbar discectomy done at 6 months of starting symptoms | Procedure or surgery | 6 months |
Primary outcome
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
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
3 secondary outcomes
Visual analogue scale
Time frame: Visual analogue scale was measured at 2 weeks
Length of hospital stay
Time frame: Measuring the days of postoperative hospital stay immediately after the surgery
Return to daily activities
Time frame: Measuring the time needed t return to daily activities immediately after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Microdiscectomy at 6 weeks of symptoms, Lumbar Microdiscectomy at 3 months of symptoms and Lumbar Microdiscectomy at 6 months of symptoms in people with Lumbar Disc Herniation, run by Hawler Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability index (time frame: Oswestry disability index was measured the functional disability at 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.