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Clinical Trials/NCT01779544
NCT01779544
Completed
Not Applicable

Rehabilitation After Lumbar Surgery

Haukeland University Hospital1 site in 1 country70 target enrollmentJanuary 2013
ConditionsProlapse

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prolapse
Sponsor
Haukeland University Hospital
Enrollment
70
Locations
1
Primary Endpoint
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as endurance, strength, stretching and information. Evidence concludes that it is not harmful to return to activity after lumbar disc surgery, and restrictions to activities after these operations are today more or less nonexistent. Some studies have shown that high intensity programs might be more effective, but they are probably more expensive. In recent years cognitive interventions have received more attention in rehabilitation programs after lumbar disc surgery. The cognitive approach is focused on providing patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation program after lumbar disc surgery.

The study will be a randomized clinical trial. The study will compare two different post-operative rehabilitation programs (general information or general information + exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy group are supposed to continue with exercises 3 months.

In this study the following hypothesis will be studied:

  1. Brief intervention, an educational model, alone after lumbar disc surgery do have the same effect on pain in legs and low back as brief intervention, an educational model, combined with exercise therapy.
  2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.
Registry
clinicaltrials.gov
Start Date
January 2013
End Date
November 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with lumbar disc prolapse with radicular pain
  • Age between 18 and 60

Exclusion Criteria

  • Previous lumbar disc surgery (prolapse)
  • Spondyloarthritis
  • Arthritis
  • Systematic disease
  • Heart disease
  • Does not understand Norwegian language, spoken or in writing

Outcomes

Primary Outcomes

Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery

Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

Secondary Outcomes

  • Change from baseline in health condition at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
  • Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
  • Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
  • Recidive prolapse(1 year postsurgery)
  • Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
  • Disability and beliefs about the condition(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
  • Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
  • Change from baseline in anticipation to return to work at 6-8 weeks postsurgery(Baseline and 6-8 weeks postsurgery postsurgery)

Study Sites (1)

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