Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis

Study Overview
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Brief Summary
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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?

Official Title
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Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis

Conditions
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Lumbar Disc Herniation, Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: Low back pain surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duration of symptoms more than 3 months Positive imaging findings Non-surgical treatment unsuccessful Exclusion Criteria: Age below 18 or above 65 years Lumbar fusion Psychiatric disorders Other serious diseases Unable to understand the Danish language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar disc herniation<br>Patients with surgery for lumbar disc herniation; | Procedure: Low back pain surgery<br> <br> |
| Spinal stenosis<br>Patients with surgery for lumbar spinal stenosis | Procedure: Low back pain surgery<br> <br> |
| No surgery<br>Patients with no surgery for lumbar disc herniation; patients with no surgery for lumbar spinal stenosis; | Procedure: Low back pain surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement | 2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 2 years follow-up | 
| Reoperation during follow-up | Self reporting by questionnare | 2 years follow-up | 
| Sick leave because of back pain | Self reporting by questionnare | 2 years follow-up | 
| Contacts to the health care system because of back pain | Self reporting by questionnare | 2 years follow-up |