NCT00711711

Brief Summary

The purpose of this study is to evaluate the efficiency of manual lymphatic drainage to decrease the swelling of the knee after total knee replacement surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

January 18, 2019

Completed
Last Updated

January 18, 2019

Status Verified

August 1, 2018

Enrollment Period

2.6 years

First QC Date

July 8, 2008

Results QC Date

September 2, 2016

Last Update Submit

August 1, 2018

Conditions

Knee Arthroplasty, Total

Keywords

Physical Therapy - Therapeutics - EdemaArthroplasty replacement kneeTreatment outcome

Outcome Measures

Primary Outcomes (2)

  • Bioimpedance Percentage Difference Healthy/Operated

    The bioimpedance, i.e. a measurement in ohms of the opposition to current flow between electrodes was evaluated for each limb. Then the bioimpedance percentage difference between operated and healthy limb was calculated.

    presurgery, 2 days, 7 days and 3 months post surgery

  • Lower Limb Volume Percentage Difference Operated/Healthy

    The limb volume was evaluated for each limb using circumferential tape measurements at 4 cm intervals. Then the tape measurementy were converted into limb volume using the validated truncated-cone method, and the percentage difference between the operated and the healthy limb was calculated.

    presurgery, and 2 days, 7 days and 3 months after surgery

Study Arms (2)

Manual lymphatic drainage

EXPERIMENTAL

this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery

Other: Manual lymphatic drainage

Relaxation

PLACEBO COMPARATOR

This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery

Other: relaxation

Interventions

Manual lymphatic drainageOTHER

Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery

Also known as: lymphatic drainage, manual lymph drainage, MLD
Manual lymphatic drainage
relaxationOTHER

Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery

Also known as: eriksonian hypnosis
Relaxation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • knee replacement surgery

You may not qualify if:

  • pacemaker
  • cardiac defibrillator
  • pathology of the lymphatic system
  • lower limb impairment which interferes with gait
  • neurological disease
  • unability to understand patient information letter or to give informed consent
  • unability to understand and complete questionnaires in French
  • contraindication to manual lymphatic drainage : thrombosis, infection, right cardiac insufficiency, active cancer
  • non standard knee replacement surgery
  • high dose anticoagulation
  • post surgical complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Département de l'Appareil Locomoteur - CHUV

Lausanne, 1005, Switzerland

Location

Haute Ecole Cantonale Vaudoise de Santé

Lausanne, 1011, Switzerland

Location

Related Publications (1)

  • Pichonnaz C, Bassin JP, Lecureux E, Christe G, Currat D, Aminian K, Jolles BM. Effect of Manual Lymphatic Drainage After Total Knee Arthroplasty: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 May;97(5):674-82. doi: 10.1016/j.apmr.2016.01.006. Epub 2016 Jan 30.

    PMID: 26829760DERIVED

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Results Point of Contact

Title
Pr. Claude Pichonnaz
Organization
HECVSanté
claude.pichonnaz@hesav.ch
++41213168126

Study Officials

  • Claude Pichonnaz, physiother

    Haute Ecole Cantonale Vaudoise de Santé + Département de l'Appareil Locomoteur - CHUV

    PRINCIPAL INVESTIGATOR

  • Brigitte M Jolles, PD MER MSc

    Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 9, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

January 18, 2019

Results First Posted

January 18, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)