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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02836730
Enrollment
425
Registered
2016-07-19
Start date
2004-11-30
Completion date
2016-01-31
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation, Lumbar Spinal Stenosis

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?

Interventions

PROCEDURELow back pain surgery

Sponsors

University Hospital Bispebjerg and Frederiksberg
CollaboratorOTHER
University of Southern Denmark
CollaboratorOTHER
Back and Rehabilitation Center, Copenhagen
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disability2 years follow-upRoland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement

Secondary

MeasureTime frameDescription
Reoperation during follow-up2 years follow-upSelf reporting by questionnare
Sick leave because of back pain2 years follow-upSelf reporting by questionnare
Contacts to the health care system because of back pain2 years follow-upSelf reporting by questionnare
Back og leg pain2 years follow-up10 point Numeric Rating Scales for current pain, worst pain and average pain. Lack of success defined as less than 30% improvement.
Global outcome2 years follow-up5 point Likert Scale. Lack of success is defined as a score of No change, Worse, or Much worse

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026