Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
Primary Purpose
Prolapse
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Brief intervention, an educational model
Exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prolapse focused on measuring rehabilitation,surgery,brief intervention, exercises
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
Sites / Locations
- Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Brief intervention only
Exercise group
Arm Description
Brief intervention, an educational model, consists of information
Brief educational intervention combined with exercise therapy
Outcomes
Primary Outcome Measures
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Secondary Outcome Measures
Disability and beliefs about the condition
Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery
Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery
Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
Change from baseline in health condition at 6-8 weeks and 1 year postsurgery
Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery
Recidive prolapse
Full Information
NCT ID
NCT01779544
First Posted
January 24, 2013
Last Updated
August 7, 2019
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01779544
Brief Title
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
Official Title
Rehabilitation After Lumbar Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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:
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.
Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse
Keywords
rehabilitation,surgery,brief intervention, exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief intervention only
Arm Type
Active Comparator
Arm Description
Brief intervention, an educational model, consists of information
Arm Title
Exercise group
Arm Type
Active Comparator
Arm Description
Brief educational intervention combined with exercise therapy
Intervention Type
Other
Intervention Name(s)
Brief intervention, an educational model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Disability and beliefs about the condition
Time Frame
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Title
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
Title
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
Title
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
Title
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
Time Frame
Baseline and 6-8 weeks postsurgery postsurgery
Title
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
Title
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
Title
Recidive prolapse
Time Frame
1 year postsurgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Indrekvam, phd, MD
Organizational Affiliation
Helse Bergen HF, Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
City
Bergen
State/Province
Hordaland
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
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