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

NCT ID: NCT02836730

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 425 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2016-01-31

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?

Conditions

Lumbar Disc Herniation; Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lumbar disc herniation

Patients with surgery for lumbar disc herniation;

Low back pain surgery

Intervention Type: PROCEDURE

Spinal stenosis

Patients with surgery for lumbar spinal stenosis

Low back pain surgery

Intervention Type: PROCEDURE

No surgery

Patients with no surgery for lumbar disc herniation; patients with no surgery for lumbar spinal stenosis;

Low back pain surgery

Intervention Type: PROCEDURE

Interventions

Low back pain surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Back and Rehabilitation Center, Copenhagen

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tom Petersen

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Back and Rehabilitation Center Copenhagen

Copenhagen, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

Kirurgi-1507-2016

Identifier Type: -

Identifier Source: org_study_id