Clinical Trial: Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Long Term Follow-up of Comprehensive Physiotherapy Following Disc Herniation Operation: Results of a Randomized Clinical Trial
Brief Summary:
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.
Detailed Summary: Design: Twelve years' follow-up of a three-armed, randomized, controlled, single blinded clinical trial. Setting: Outpatient department of Physical Medicine & Rehabilitation. Participants: Of 120 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study are invited to a 12 years follow-up examination. Interventions: In the original study, patients had been randomly assigned to "comprehensive physiotherapy", "sham intervention" (neck massage), or no therapy. Measurements: Low Back Pain Rating Score (LBPRS; Manniche 1993), functional X-rays of the lumbar spine. All data are collected by blinded students and physicians at the Department of PM&R, Vienna Medical University.
Sponsor: Medical University of Vienna
Current Primary Outcome: Low back pain rating scale (LBP-RS) [ Time Frame: 12 years after Randomization ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Satisfaction with treatment [ Time Frame: 12 years ]Ratings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline
- Use of health care resources [ Time Frame: 12 years ]questions related to the use of health care resources because of back pain, and the necessity of reoperation of a disc herniation
- Psychological questionnaires [ Time Frame: 12 years ]Fear Avoidance beliefs questionnaire, MOS 36-Item Short Form Health Survey, Heidelberger Pain Inventory Symptom Checklist-90R (SCL-90R) Beck Depression Inventory (BDI)
Original Secondary Outcome: Same as current
Information By: Medical University of Vienna
Dates:
Date Received: August 12, 2013
Date Started: July 1996
Date Completion:
Last Updated: August 13, 2013
Last Verified: August 2013