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Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT

Long Term Follow-up of Comprehensive Physiotherapy Following Disc Herniation Operation: Results of a Randomized Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01922063
Enrollment
120
Registered
2013-08-14
Start date
1996-07-31
Completion date
2010-03-31
Last updated
2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervertebral Disc Displacement

Keywords

disc herniation surgery, physiotherapy, exercise therapy, randomized, long term, follow up

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 description

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.

Interventions

20x 30 min sessions of physiotherapy

BEHAVIORALSham neck massage

20x 30 minutes sessions of neck massage

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Low back pain rating scale (LBP-RS)12 years after RandomizationThe 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).

Secondary

MeasureTime frameDescription
Satisfaction with treatment12 yearsRatings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline
Use of health care resources12 yearsquestions related to the use of health care resources because of back pain, and the necessity of reoperation of a disc herniation
Psychological questionnaires12 yearsFear Avoidance beliefs questionnaire, MOS 36-Item Short Form Health Survey, Heidelberger Pain Inventory Symptom Checklist-90R (SCL-90R) Beck Depression Inventory (BDI)

Other

MeasureTime frameDescription
X Rays12 yearsFunctional X rays of the lumbar spine

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026