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

NCT ID: NCT01922063

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Intervertebral Disc Displacement

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Physiotherapy Intervention

Intervention Type BEHAVIORAL

20x 30 min sessions of physiotherapy

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

Group Type SHAM_COMPARATOR

Sham neck massage

Intervention Type BEHAVIORAL

20x 30 minutes sessions of neck massage

No therapy

no further therapy, patients were asked to "wait and see" for the first three months after operation, and no particular treatment was planned

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physiotherapy Intervention

20x 30 min sessions of physiotherapy

Intervention Type BEHAVIORAL

Sham neck massage

20x 30 minutes sessions of neck massage

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Gerold Ebenbichler

Prof Dr Gerold Ebenbichler

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerold Ebenbichler, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Dept Physical Medicine & Rehabilitation, MUV, AKH

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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EK Nr. 301/2009

Identifier Type: OTHER

Identifier Source: secondary_id

PMR_Ebe01/2009

Identifier Type: -

Identifier Source: org_study_id