NCT02836730

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

11.2 years

First QC Date

July 15, 2016

Last Update Submit

July 15, 2016

Conditions

Lumbar Disc HerniationLumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • Disability

    Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement

    2 years follow-up

Secondary Outcomes (5)

  • Back og leg pain

    2 years follow-up

  • Global outcome

    2 years follow-up

  • Reoperation during follow-up

    2 years follow-up

  • Sick leave because of back pain

    2 years follow-up

  • Contacts to the health care system because of back pain

    2 years follow-up

Study Arms (3)

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

Interventions

Low back pain surgeryPROCEDURE
Lumbar disc herniationNo surgerySpinal stenosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Duration of symptoms more than 3 months
  • Positive imaging findings
  • Non-surgical treatment unsuccessful

You may not qualify if:

  • Age below 18 or above 65 years
  • Lumbar fusion
  • Psychiatric disorders
  • Other serious diseases
  • Unable to understand the Danish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Back and Rehabilitation Center Copenhagen

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 19, 2016

Study Start

November 1, 2004

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

DK(1)