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

Phase 3CompletedNCT01922063

Medical University of Vienna120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Intervertebral Disc Displacement

Interventions

Physiotherapy InterventionBEHAVIORAL

20x 30 min sessions of physiotherapy

Sham neck massageBEHAVIORAL

20x 30 minutes sessions of neck massage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dept Physical Medicine & Rehabilitation, MUV, AKH

Vienna, Austria

Outcomes

Primary Outcomes

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).

Time frame: 12 years after Randomization

Secondary Outcomes

Satisfaction with treatment

Ratings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline

Time frame: 12 years

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

Time frame: 12 years

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)

Time frame: 12 years

Data from ClinicalTrials.gov

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