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 ]

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).


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