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

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 Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Low back pain surgery

• Study Type: Observational
• Enrollment (Actual): 425

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Back and Rehabilitation Center Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lumbar disc herniation; Patients with surgery for lumbar disc herniation;	Procedure: Low back pain surgery
Spinal stenosis; Patients with surgery for lumbar spinal stenosis	Procedure: Low back pain surgery
No surgery; Patients with no surgery for lumbar disc herniation; patients with no surgery for lumbar spinal stenosis;	Procedure: Low back pain surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Back and Rehabilitation Center, Copenhagen
• Collaborators: University of Southern Denmark; University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Sciatica; Hernia; Intervertebral Disc Displacement; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: Kirurgi-1507-2016