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

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836730
• Other study ID #: Kirurgi-1507-2016
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: July 15, 2016
• Start date: November 2004
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Back and Rehabilitation Center, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical 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 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constriction, Pathologic
• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Sciatica
• Spinal Stenosis

Intervention

Procedure:
• Low back pain surgery

Locations

Country	Name	City	State
Denmark	Back and Rehabilitation Center Copenhagen	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Back and Rehabilitation Center, Copenhagen	University Hospital Bispebjerg and Frederiksberg, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement	2 years follow-up	No
Secondary	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	No
Secondary	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	No
Secondary	Reoperation during follow-up	Self reporting by questionnare	2 years follow-up	No
Secondary	Sick leave because of back pain	Self reporting by questionnare	2 years follow-up	No
Secondary	Contacts to the health care system because of back pain	Self reporting by questionnare	2 years follow-up	No