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

Completed

• Conditions: Lumbar Spinal Stenosis; Lumbar Disc Herniation
• Interventions: Procedure: Low back pain surgery

• Registration Number: NCT02836730
• Lead Sponsor: Back and Rehabilitation Center, Copenhagen

Brief 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 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Study First Posted: 2016-07-19
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal stenosis	Low back pain surgery	Patients with surgery for lumbar spinal stenosis
Lumbar disc herniation	Low back pain surgery	Patients with surgery for lumbar disc herniation;
No surgery	Low back pain surgery	Patients with no surgery for lumbar disc herniation; patients with no surgery for lumbar spinal stenosis;

Primary Outcome Measures

Name	Time	Method
Disability	2 years follow-up	Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement

Secondary Outcome Measures

Name	Time	Method
Reoperation during follow-up	2 years follow-up	Self reporting by questionnare
Sick leave because of back pain	2 years follow-up	Self reporting by questionnare
Global outcome	2 years follow-up	5 point Likert Scale. Lack of success is defined as a score of No change, Worse, or Much worse
Contacts to the health care system because of back pain	2 years follow-up	Self reporting by questionnare
Back og leg pain	2 years follow-up	10 point Numeric Rating Scales for current pain, worst pain and average pain. Lack of success defined as less than 30% improvement.

Trial Locations

Locations (1)

Back and Rehabilitation Center Copenhagen; 🇩🇰 Copenhagen, Denmark