Prolapse Clinical Trial
Official title:
Rehabilitation After Lumbar Surgery
NCT number | NCT01779544 |
Other study ID # | 2012/1861 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2013 |
Est. completion date | November 2016 |
Verified date | February 2017 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik | Bergen | Hordaland |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Disability and beliefs about the condition | Baseline, 6-8 weeks postsurgery and 1 year postsurgery | ||
Secondary | Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery | Baseline, 6-8 weeks postsurgery and 1 year postsurgery | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Change from baseline in anticipation to return to work at 6-8 weeks postsurgery | Baseline and 6-8 weeks postsurgery postsurgery | ||
Secondary | Change from baseline in health condition at 6-8 weeks and 1 year postsurgery | Baseline, 6-8 weeks postsurgery and 1 year postsurgery | ||
Secondary | Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery | Baseline, 6-8 weeks postsurgery and 1 year postsurgery | ||
Secondary | Recidive prolapse | 1 year postsurgery |
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