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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

Study Description
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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?


Condition or disease Intervention/treatment
Lumbar Disc Herniation Lumbar Spinal Stenosis Procedure: Low back pain surgery

Study Design
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Study Type : Observational
Actual Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis
Study Start Date : November 2004
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Disability [ Time Frame: 2 years follow-up ]
    Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Reoperation during follow-up [ Time Frame: 2 years follow-up ]
    Self reporting by questionnare

  4. Sick leave because of back pain [ Time Frame: 2 years follow-up ]
    Self reporting by questionnare

  5. Contacts to the health care system because of back pain [ Time Frame: 2 years follow-up ]
    Self reporting by questionnare


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836730


Locations
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Denmark
Back and Rehabilitation Center Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Back and Rehabilitation Center, Copenhagen
University Hospital Bispebjerg and Frederiksberg
University of Southern Denmark
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Tom Petersen, Researcher, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier: NCT02836730    
Other Study ID Numbers: Kirurgi-1507-2016
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Spinal Stenosis
Sciatica
Constriction, Pathologic
Hernia
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
 Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations