Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention

Sponsor
Haukeland University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01779544
Collaborator
(none)
70
1
2
46
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Brief intervention, an educational model
  • Other: Exercise therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Rehabilitation After Lumbar Surgery
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Brief intervention only

Brief intervention, an educational model, consists of information

Other: Brief intervention, an educational model
The goal of the the brief intervention is to provide the 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.

Active Comparator: Exercise group

Brief educational intervention combined with exercise therapy

Other: Brief intervention, an educational model
The goal of the the brief intervention is to provide the 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.

Other: Exercise therapy
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery [Baseline, 6-8 weeks postsurgery and 1 year postsurgery]

Secondary Outcome Measures

  1. Disability and beliefs about the condition [Baseline, 6-8 weeks postsurgery and 1 year postsurgery]

  2. Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery [Baseline, 6-8 weeks postsurgery and 1 year postsurgery]

  3. 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]

  4. 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]

  5. Change from baseline in anticipation to return to work at 6-8 weeks postsurgery [Baseline and 6-8 weeks postsurgery postsurgery]

  6. Change from baseline in health condition at 6-8 weeks and 1 year postsurgery [Baseline, 6-8 weeks postsurgery and 1 year postsurgery]

  7. Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery [Baseline, 6-8 weeks postsurgery and 1 year postsurgery]

  8. Recidive prolapse [1 year postsurgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik Bergen Hordaland Norway

Sponsors and Collaborators

  • Haukeland University Hospital

Investigators

  • Study Director: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01779544
Other Study ID Numbers:
  • 2012/1861
First Posted:
Jan 30, 2013
Last Update Posted:
Aug 9, 2019
Last Verified:
Feb 1, 2017
Keywords provided by Haukeland University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2019