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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01779544
First received: January 24, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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 Intervention
Prolapse
Other: Brief intervention, an educational model
Other: Exercise therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation After Lumbar Surgery

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability and beliefs about the condition [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
  • Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
  • Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
  • Change from baseline in anticipation to return to work at 6-8 weeks postsurgery [ Time Frame: Baseline and 6-8 weeks postsurgery postsurgery ] [ Designated as safety issue: No ]
  • Change from baseline in health condition at 6-8 weeks and 1 year postsurgery [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
  • Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
  • Recidive prolapse [ Time Frame: 1 year postsurgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779544

Contacts
Contact: Vegard Pihl Moen, MSc, PT +4756565971 vegard.pihl.moen@helse-bergen.no
Contact: Eva Saltskår Jentoft, PT +4756565910 eva.saltskar.jentoft@helse-bergen.no

Locations
Norway
Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik Recruiting
Bergen, Hordaland, Norway
Contact: Vegard P moen, MSc, PT    +4756565971    vegard.pihl.moen@helse-bergen.no   
Contact: Eva S Jentoft, PT    +4756565910    eva.saltskar.jentoft@helse-bergen.no   
Principal Investigator: Kari Indrekvam, phd, MD         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Director: Kari Indrekvam, phd, MD Helse Bergen HF, Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01779544     History of Changes
Other Study ID Numbers: 2012/1861
Study First Received: January 24, 2013
Last Updated: November 26, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
rehabilitation,surgery,brief intervention, exercises

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014