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

Phase 3

Completed

• Conditions: Intervertebral Disc Displacement
• Interventions: Behavioral: Physiotherapy Intervention; Behavioral: Sham neck massage

• Registration Number: NCT01922063
• Lead Sponsor: Medical University of Vienna

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1996-07
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-08
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-13
• Last Update Submitted: 2013-08-13
• Study First Posted: 2013-08-14
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

• n.a.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiotherapy Intervention	Physiotherapy Intervention	20 treatment sessions of a comprehensive physiotherapy program, 12 weeks' duration, with custom tailored instructions by the supervising physician; physicians discussed the course of therapy with the physiotherapist 1x/week. Patients had been treated by physiotherapist according to written prescriptions. Duration of treatment 30 min/ session. Patients were encouraged to practice regular home exercise.
Sham neck massage	Sham neck massage	received twenty sessions "sham" neck massage of 30 minutes' duration each with the patients lying in supine position on a massage bed and the head of the patient resting on the therapist's knees

Primary Outcome Measures

Name	Time	Method
Low back pain rating scale (LBP-RS)	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).

Secondary Outcome Measures

Name	Time	Method
Satisfaction with treatment	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	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	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)

Trial Locations

Locations (1)

Dept Physical Medicine & Rehabilitation, MUV, AKH; 🇦🇹 Vienna, Austria