NCT02278627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 27, 2026

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

September 11, 2014

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • To measure the joint range at day 7 after operation

    The measures will be made with a goniometer

    2 days (Day 0 and Day 7)

Secondary Outcomes (1)

  • To measure the oedema at day 7 after operation

    2 days (Day 0 and Day 7)

Study Arms (2)

manual lymphatic drainage

EXPERIMENTAL

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

Usual treatment

NO INTERVENTION

Interventions

manual lymphatic drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Limoges

Limoges, 87 042, France

Location

Related Publications (1)

  • https://doi.org/10.1016/j.kine.2021.11.014

    RESULT

Related Links

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

October 30, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

March 27, 2026

Record last verified: 2025-07

Locations