Orthopedic SurgeryPTGMassNCT02278627
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
A study testing manual lymphatic drainage in people with Orthopedic Surgery, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- manual lymphatic drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Orthopedic Surgery
- Being tested
- manual lymphatic drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual lymphatic drainageOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: manual lymphatic drainage |
| Usual treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the joint range at day 7 after operation
The measures will be made with a goniometer
Measured: 2 days (Day 0 and Day 7)
Secondary outcomes (1)
To measure the oedema at day 7 after operation
Measured: 2 days (Day 0 and Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278627
- Sponsor's protocol ID
- I11002
- Acronym
- PTGMass
- Status last verified
- Jul 2025
- First submitted
- 11 Sep 2014
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
https://doi.org/10.1016/j.kine.2021.11.014
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02278627
- Acronym / sponsor ID
- PTGMass / I11002
- Conditions
- Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual lymphatic drainage | Experimental | Other: manual lymphatic drainageWe wish to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS) |
| Usual treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual lymphatic drainage | Other | manual lymphatic drainage |
Primary outcome
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
1 secondary outcome
To measure the oedema at day 7 after operation
Time frame: 2 days (Day 0 and Day 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publicationhttps://doi.org/10.1016/j.kine.2021.11.014
- Brigitte Preneuf-Pauthier ; Impact of a manual veno-lymphatic stimulation according to the Schiltz method on the recovery of knee mobility following total knee arthroplasty: A randomized controlled trial Kinésithérapie, la Revue ; Volume 22, Issue 250,Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual lymphatic drainage in people with Orthopedic Surgery, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the joint range at day 7 after operation (time frame: 2 days (Day 0 and Day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.