Overview

This trial is active, not recruiting.

Condition prolapse
Treatments brief intervention, an educational model, exercise therapy
Sponsor Haukeland University Hospital
Start date January 2013
End date December 2016
Trial size 80 participants
Trial identifier NCT01779544, 2012/1861

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Brief intervention, an educational model, consists of information
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)
Brief educational intervention combined with exercise therapy
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.
exercise therapy
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these

Primary Outcomes

Measure
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

Measure
Disability and beliefs about the condition
time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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
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
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
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
time frame: Baseline and 6-8 weeks postsurgery postsurgery
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
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
Recidive prolapse
time frame: 1 year postsurgery

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Rehabilitation After Lumbar Surgery
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.