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

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ClinicalTrials.gov Identifier: NCT02836730
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Collaborators:
University Hospital Bispebjerg and Frederiksberg
University of Southern Denmark
Information provided by (Responsible Party):
Tom Petersen, Back and Rehabilitation Center, Copenhagen

Tracking Information
First Submitted Date July 15, 2016
First Posted Date July 19, 2016
Last Update Posted Date July 19, 2016
Study Start Date November 2004
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2016)
Disability [ Time Frame: 2 years follow-up ]
Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 15, 2016)
  • Back og leg pain [ Time Frame: 2 years follow-up ]
    10 point Numeric Rating Scales for current pain, worst pain and average pain. Lack of success defined as less than 30% improvement.
  • Global outcome [ Time Frame: 2 years follow-up ]
    5 point Likert Scale. Lack of success is defined as a score of No change, Worse, or Much worse
  • Reoperation during follow-up [ Time Frame: 2 years follow-up ]
    Self reporting by questionnare
  • Sick leave because of back pain [ Time Frame: 2 years follow-up ]
    Self reporting by questionnare
  • Contacts to the health care system because of back pain [ Time Frame: 2 years follow-up ]
    Self reporting by questionnare
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis
Official Title Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or 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?

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Lumbar Disc Herniation
  • Lumbar Spinal Stenosis
Intervention Procedure: Low back pain surgery
Study Groups/Cohorts
  • Lumbar disc herniation
    Patients with surgery for lumbar disc herniation;
    Intervention: Procedure: Low back pain surgery
  • Spinal stenosis
    Patients with surgery for lumbar spinal stenosis
    Intervention: Procedure: Low back pain surgery
  • No surgery
    Patients with no surgery for lumbar disc herniation; patients with no surgery for lumbar spinal stenosis;
    Intervention: Procedure: Low back pain surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2016)
425
Original Actual Enrollment Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02836730
Other Study ID Numbers Kirurgi-1507-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tom Petersen, Back and Rehabilitation Center, Copenhagen
Study Sponsor Back and Rehabilitation Center, Copenhagen
Collaborators
  • University Hospital Bispebjerg and Frederiksberg
  • University of Southern Denmark
Investigators Not Provided
PRS Account Back and Rehabilitation Center, Copenhagen
Verification Date July 2016