Clinical trial NCT01779544: Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
Official title: Rehabilitation After Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Keywords: rehabilitation,surgery,brief intervention, exercises
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
timeFrame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary outcomes:
measure: Disability and beliefs about the condition
timeFrame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
measure: Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery
timeFrame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
measure: Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery
timeFrame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
measure: Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery
timeFrame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
measure: Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
timeFrame: Baseline and 6-8 weeks postsurgery postsurgery
measure: Change from baseline in health condition at 6-8 weeks and 1 year postsurgery
timeFrame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
measure: Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery
timeFrame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
measure: Recidive prolapse
timeFrame: 1 year postsurgery
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
state: Hordaland
Study officials:
affiliation: Helse Bergen HF, Haukeland University Hospital
name: Kari Indrekvam, phd, MD
role: STUDY_DIRECTOR
References: