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Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement (PTGMass)

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ClinicalTrials.gov Identifier: NCT02278627
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

During fthe first postoperative days, physiotherapists supported patients with knee replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes movements of the leg in active and non active motions, without any help and with an arthromotor, and involves walking rehabilitation.

The investigators would like to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might have a positive impact on time recovery of joint range, on postoperative oedema resorbtion and on patient's pain during rehabilitation classes.

French National Authority for Health specifies there is not a single study assessing massage effects on knee replacement, according to current bibliography.

The investigators purpose is the establishment of a prospective, controlled, randomised trial referred as a "superiority" trial. A total of 98 patients divided in 2 parallel groups will be created.

The study will be in an open-label manner for both patient and physiotherapist involved in walk rehabilitation but will be conducted as a blinded study for the investigating physiotherapist.

Inclusion period will be 17 months and the following period will be 6 weeks.


Condition or disease Intervention/treatment Phase
Orthopedic Surgery Other: manual lymphatic drainage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement
Study Start Date : September 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: manual lymphatic drainage
We wish to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS)
Other: manual lymphatic drainage
No Intervention: Usual treatment



Primary Outcome Measures :
  1. To measure the joint range at day 7 after operation [ Time Frame: 2 days (Day 0 and Day 7) ]
    The measures will be made with a goniometer


Secondary Outcome Measures :
  1. To measure the oedema at day 7 after operation [ Time Frame: 2 days (Day 0 and Day 7) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18-years-old patients.
  • Men and women operated for a knee replacement.
  • Patients affiliated to a social security system and having given their informed consent write.

Exclusion Criteria:

  • Patients operated on Fridays
  • Patients presenting contraindications to the administration of a treatment by héparine
  • Patients affected by insane pathology or by confusion.
  • Patients participating in another medical research
  • Pregnant and breast-feeding women and without effective contraception.
  • Patients under guardianship or guardianship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278627


Locations
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France
University Hospital, Limoges
Limoges, France, 87 042
Sponsors and Collaborators
University Hospital, Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02278627    
Other Study ID Numbers: I11002
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: February 2017