Impact of Physiotherapy on Short-term Outcome After Meniscectomy

December 26, 2022 updated by: University Hospital, Ghent

Study of Impact of Physiotherapy on Short-term Outcome After Meniscectomy.

In this study we investigate whether physiotherapy offers added value in rehabilitation after meniscectomy compared with no therapy or a home program. The population consists of 180 post-operative meniscus injury patients, operated at UZ Gent, the first 60 patients received no therapy, the next 60 patients were offered a treatment by their home physiotherapist according to our established protocol and the last 60 patients we have prepared a home program .

The physiotherapeutic treatment has been prepared based on scientific literature and own experience from the program at Ghent University and internships. It includes exercises to promote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient. This schedule will be given to the patient along with the questionnaires at registration of the operation and will serve as a guideline for the physiotherapist for the rehabilitation of the patient after surgery. Monitoring of the evolution will take place by calling the physiotherapist on regular basis.

The home program is prepared on the basis of commonly used home exercises after arthroscopy and also includes exercises to promote mobility, strength and stability and exercises to reduce pain and swelling. The difference with the physiotherapeutic treatment is that there is no control and supervision of a physiotherapist and that the treatment is more limited. This program is given with the patient along with the questionnaires at registration of the operation.

Pre-operatively and 4 weeks, 3 months, 6 months and 12 months post-operatively, an evaluation of the current condition of the patient will happen on the basis of standardized questionnaires. Based on the results of these questionnaires, collected at different times, we can determine which treatment provides the best rehabilitation after meniscectomy. The first (preoperative) questionnaire, given at registration of the operation, is completed and given to the nurse of the day hospital on the day of surgery, the other (postoperative) questionnaires are sent electronically to the patient's email address and need to be returned, after filling up.

This study spends specific attention to the speed of resumption of work / sports and daily activities and the presence or absence of complaints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post-operative meniscectomy and surgery at Ghent University Hospital

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Rest
Active Comparator: physiotherapy
Promote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient.
Behavioral: Therapy
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 40min.
Active Comparator: Home exercises
Promote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient.
Behavioral: Exercise therapy
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 30 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the Tegner questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the Tegner questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the Tegner questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the Tegner questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the Tegner questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from a physiotherapeutic questionnaire.
Pre-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of a total number of complaints.
Time Frame: pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative.
This outcome will be derived from questionnaires: VAS, KOOS, SF-36, TEGNER, FORSS, physiotherapeutic questionnaire
pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2012/161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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