Lumbar Disc HerniationNCT02836730
Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis
An observational study of Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
Trial summary
The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar disc herniation and 60-70% in patients with spinal stenosis. At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc herniation and spinal stenosis are treated by a multidisciplinary team… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- What is being tested?
- Low back pain surgery
- Type of treatment
- Surgery or procedure
- How many people
- 425 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2004to Jan 2016
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with low back pain referred to surgical evaluation with positive MRI findings, persistent low back pain, and poor outcome following non-operative treatment
Who may be able to join
- Duration of symptoms more than 3 months
- Positive imaging findings
- Non-surgical treatment unsuccessful
Who cannot join
- Age below 18 or above 65 years
- Lumbar fusion
- Psychiatric disorders
- Other serious diseases
- Unable to understand the Danish language
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Back and Rehabilitation Center Copenhagen
Copenhagen, Copenhagen, 2100
About this study
The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar disc herniation and 60-70% in patients with spinal stenosis.
At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc herniation and spinal stenosis are treated by a multidisciplinary team comprising rheumatologists, physiotherapists, chiropractors, and social workers according to current guidelines. Therefore we have a unique opportunity to report the long term outcome in candidates for surgery, regardless of whether they have surgery or not, after having received optimal but unsuccessful nonsurgical treatment.
The purpose of this study is to answer the following questions: 1) What is the proportion of patients operated upon after referral to surgical evaluation with positive MRI findings, persistent low back pain, and poor outcome following non-operative treatment? 2) What was the outcome in these patients 2 years following referral? 3) Where any baseline variables predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in patients with or without surgery?
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- Being tested
- Low back pain surgery
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low back pain surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lumbar disc herniation | Patients with surgery for lumbar disc herniation; Receives: Procedure: Low back pain surgery | |
| Spinal stenosis | Patients with surgery for lumbar spinal stenosis Receives: Procedure: Low back pain surgery | |
| No surgery | Patients with no surgery for lumbar disc herniation; patients with no surgery for lumbar spinal stenosis; Receives: Procedure: Low back pain surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement
Measured: 2 years follow-up
Secondary outcomes (5)
Back og leg pain
10 point Numeric Rating Scales for current pain, worst pain and average pain. Lack of success defined as less than 30% improvement.
Measured: 2 years follow-up
Global outcome
5 point Likert Scale. Lack of success is defined as a score of No change, Worse, or Much worse
Measured: 2 years follow-up
Reoperation during follow-up
Self reporting by questionnare
Measured: 2 years follow-up
Sick leave because of back pain
Self reporting by questionnare
Measured: 2 years follow-up
Contacts to the health care system because of back pain
Self reporting by questionnare
Measured: 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startNov 2004
- Primary completionJan 2016
- Study completionJan 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Back and Rehabilitation Center, Copenhagen
- Sponsor type
- Other government
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, University of Southern Denmark
- Responsible party
- Principal investigator, Tom Petersen, Back and Rehabilitation Center, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836730
- Sponsor's protocol ID
- Kirurgi-1507-2016
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis
- ClinicalTrials.gov ID
- NCT02836730
- Acronym / sponsor ID
- Kirurgi-1507-2016
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Back and Rehabilitation Center, CopenhagenOther government
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, University of Southern Denmark
- Study start
- Nov 2004
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar disc herniation and 60-70% in patients with spinal stenosis.
At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc herniation and spinal stenosis are treated by a multidisciplinary team comprising rheumatologists, physiotherapists, chiropractors, and social workers according to current guidelines. Therefore we have a unique opportunity to report the long term outcome in candidates for surgery, regardless of whether they have surgery or not, after having received optimal but unsuccessful nonsurgical treatment.
The purpose of this study is to answer the following questions: 1) What is the proportion of patients operated upon after referral to surgical evaluation with positive MRI findings, persistent low back pain, and poor outcome following non-operative treatment? 2) What was the outcome in these patients 2 years following referral? 3) Where any baseline variables predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in patients with or without surgery?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar disc herniation | – | Procedure: Low back pain surgeryPatients with surgery for lumbar disc herniation; |
| Spinal stenosis | – | Procedure: Low back pain surgeryPatients with surgery for lumbar spinal stenosis |
| No surgery | – | Procedure: Low back pain surgeryPatients with no surgery for lumbar disc herniation; patients with no surgery for lumbar spinal stenosis; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low back pain referred to surgical evaluation with positive MRI findings, persistent low back pain, and poor outcome following non-operative treatment
Key inclusion criteria (3 listed)
- Duration of symptoms more than 3 months
- Positive imaging findings
- Non-surgical treatment unsuccessful
Key exclusion criteria (5 listed)
- Age below 18 or above 65 years
- Lumbar fusion
- Psychiatric disorders
- Other serious diseases
- Unable to understand the Danish language
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 |
|---|---|---|
| Low back pain surgery | Procedure or surgery | Lumbar disc herniation, No surgery, Spinal stenosis |
Primary outcome
Disability
Time frame: 2 years follow-up
Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement
5 secondary outcomes
Back og leg pain
Time frame: 2 years follow-up
Global outcome
Time frame: 2 years follow-up
Reoperation during follow-up
Time frame: 2 years follow-up
Sick leave because of back pain
Time frame: 2 years follow-up
Contacts to the health care system because of back pain
Time frame: 2 years follow-up
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 19 Jul 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
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 5 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Disability (time frame: 2 years follow-up). 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 19 Jul 2016.