Impact of Physiotherapy on Short-term Outcome After Meniscectomy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Meniscectomy |
Behavioral: Therapy Behavioral: Exercise therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Impact of Physiotherapy on Short-term Outcome After Meniscectomy. |
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the Tegner questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]This outcome will be derived from a physiotherapeutic questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the Tegner questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from a physiotherapeutic questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the Tegner questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]This outcome will be derived from a physiotherapeutic questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the Tegner questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]This outcome will be derived from a physiotherapeutic questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]This outcome will be derived from the Tegner questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
- Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]This outcome will be derived from a physiotherapeutic questionnaire.
- The presence of a total number of complaints. [ Time Frame: pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative. ] [ Designated as safety issue: No ]This outcome will be derived from questionnaires: VAS, KOOS, SF-36, TEGNER, FORSS, physiotherapeutic questionnaire
| Estimated Enrollment: | 180 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
| No Intervention: Rest | |
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Post-operative meniscectomy and surgery at Ghent University Hospital
Exclusion Criteria:
Contacts and Locations| Contact: Peter Verdonck, MD, PhD | pverdonck@yahoo.com | |
| Contact: Aad Dhollander, MD | aad.dhollander@ugent.be |
| Belgium | |
| Ghent University Hospital | Not yet recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Peter Verdonck, MD, PhD pverdonck@yahoo.com | |
| Contact: Aad Dhollander, MD | |
| Principal Investigator: Peter Verdonck, MD, PhD | |
| Sub-Investigator: Aad Dhollander, MD | |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01571102 History of Changes |
| Other Study ID Numbers: | 2012/161 |
| Study First Received: | March 28, 2012 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Ethics Committee |
ClinicalTrials.gov processed this record on May 21, 2013