Intervertebral Disc Displacement Clinical Trial
Official title:
Long Term Follow-up of Comprehensive Physiotherapy Following Disc Herniation Operation: Results of a Randomized Clinical Trial
Verified date | August 2013 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained
from survivors of disc surgery that would have considered the type of postoperative care.
Objectives: 1) To evaluate the long-term effects of postoperative comprehensive
physiotherapy starting 1 week after lumbar disc surgery. 2) To assess the relative risk of
segmental instability in the operated segment 12 years following lumbar disc surgery.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had completed the treatment originally allocated - all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had not completed the treatment originally allocated Exclusion Criteria: - n.a. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Dept Physical Medicine & Rehabilitation, MUV, AKH | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | X Rays | Functional X rays of the lumbar spine | 12 years | No |
Primary | Low back pain rating scale (LBP-RS) | The LBP-RS measures the health concepts of pain, disability, and physical impairment. Both the original and the translated version of the LBP rating scale are highly reliable within and between raters, uni-dimensional and are shown to have satisfactory construct validity. The sum score ranges from 130 (worst) to 0 (best) and is the composite of 3 subscores (pain, disability, and physical function). | 12 years after Randomization | No |
Secondary | Satisfaction with treatment | Ratings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline | 12 years | No |
Secondary | Use of health care resources | questions related to the use of health care resources because of back pain, and the necessity of reoperation of a disc herniation | 12 years | No |
Secondary | Psychological questionnaires | Fear Avoidance beliefs questionnaire, MOS 36-Item Short Form Health Survey, Heidelberger Pain Inventory Symptom Checklist-90R (SCL-90R) Beck Depression Inventory (BDI) | 12 years | No |
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