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

Primary Purpose

Intervertebral Disc Displacement

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Physiotherapy Intervention
Sham neck massage
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervertebral Disc Displacement focused on measuring disc herniation surgery, physiotherapy, exercise therapy, randomized, long term, follow up

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept Physical Medicine & Rehabilitation, MUV, AKH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Physiotherapy Intervention

Sham neck massage

No therapy

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2013
Last Updated
August 13, 2013
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01922063
Brief Title
Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT
Official Title
Long Term Follow-up of Comprehensive Physiotherapy Following Disc Herniation Operation: Results of a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Displacement
Keywords
disc herniation surgery, physiotherapy, exercise therapy, randomized, long term, follow up

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham neck massage
Arm Type
Sham Comparator
Arm Description
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
Arm Title
No therapy
Arm Type
No Intervention
Arm Description
no further therapy, patients were asked to "wait and see" for the first three months after operation, and no particular treatment was planned
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy Intervention
Intervention Description
20x 30 min sessions of physiotherapy
Intervention Type
Behavioral
Intervention Name(s)
Sham neck massage
Intervention Description
20x 30 minutes sessions of neck massage
Primary Outcome Measure Information:
Title
Low back pain rating scale (LBP-RS)
Description
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 Outcome Measure Information:
Title
Satisfaction with treatment
Description
Ratings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline
Time Frame
12 years
Title
Use of health care resources
Description
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
Title
Psychological questionnaires
Description
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
Other Pre-specified Outcome Measures:
Title
X Rays
Description
Functional X rays of the lumbar spine
Time Frame
12 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerold Ebenbichler, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Physical Medicine & Rehabilitation, MUV, AKH
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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