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Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

This study has been completed.
Sponsor:
Collaborators:
University of Applied Sciences of Western Switzerland
University of Lausanne Hospitals
Information provided by:
Haute Ecole Cantonale Vaudoise de Santé
ClinicalTrials.gov Identifier:
NCT00711711
First received: July 8, 2008
Last updated: April 13, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention
Total Knee Joint Prosthesis
 Other: Manual lymphatic drainage
Other: relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haute Ecole Cantonale Vaudoise de Santé:

Primary Outcome Measures:
  • bioimpedance ratio healthy/operated [ Time Frame: presurgery, 2 days, 8 days and 3 months post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lower limb volume ratio operated/healthy [ Time Frame: presurgery, and 2 days, 8 days and 3 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2008
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual lymphatic drainage
this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery
 Other: Manual lymphatic drainage
Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery
Other Names:
  • lymphatic drainage
  • manual lymph drainage
  • MLD
Placebo Comparator: Relaxation
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery
 Other: relaxation
Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery
Other Name: eriksonian hypnosis

Detailed Description:

Background There is scientific evidence that rehabilitation has a positive influence on patients'recovery after total knee arthroplasty (TKA). According to the literature, conventional rehabilitation aims to improve knee range of motion, lower limb strength, gait, activities and pain. Although swelling is a systematic consequence of TKA surgery, less focus is put on swelling reduction. Patients develop swelling due to periarticular edema, hematoma and joint effusion. Inflammation, pain, stiffness, alteration of gait pattern, quadriceps contraction inhibition and slowing of rehabilitation are reported as consequences of swelling. Accordingly, it is likely that a therapy that would promote resorption of swelling would decrease the negative impact of swelling on patients'recovery. Manual lymph drainage (MLD) could possibly accelerate edema resorption after TKA surgery. Several authors advise MLD after TKA, and physiotherapists currently apply MLD to reduce postsurgical swelling. Its positive effect on chronic lymphedema resorption is largely accepted. Results on pain and range of motion seem interesting from an empirical point of view but, to our knowledge, no scientifically driven studies have confirmed these positive effects after orthopaedic surgery.

Aim This study aims to evaluate the effect of MLD on swelling, and parameters possibly influenced by swelling (pain, knee range of motion, knee objective and subjective function and gait pattern).

Methods This study is a randomized controlled clinical trial. Patients will be blinded from goals of the treatments and evaluators will be blinded from the treatment delivered to the patient. The effects of MLD (5 treatments of 30 minutes from the second to the eighth postsurgical day) will be compared to those of a placebo (relaxation sessions). MLD or placebo will be added to the conventional rehabilitation program of our Orthopaedic Department. Assessments will be conducted one day before surgery, two days, 8 days and 3 months after surgery. Evolution and differences between groups will be statistically assessed at each step.

Significance This project aims to improve knowledge on the efficiency of rehabilitation treatments following TKA. It will contribute to effective evaluation of the effects of a widely applied treatment. The results will help physiotherapists and medical doctors to take clinical decisions based on documented evidence. This will make a contribution to better quality of care and better allocation of resources to rehabilitation.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • knee replacement surgery

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711711

Locations
Switzerland
Département de l'Appareil Locomoteur - CHUV
Lausanne, Switzerland, 1005
Haute Ecole Cantonale Vaudoise de Santé
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Haute Ecole Cantonale Vaudoise de Santé
University of Applied Sciences of Western Switzerland
University of Lausanne Hospitals
Investigators
Principal Investigator: Claude Pichonnaz, physiother Haute Ecole Cantonale Vaudoise de Santé + Département de l'Appareil Locomoteur - CHUV
Study Director: Brigitte M Jolles, PD MER MSc Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
  More Information

No publications provided

Responsible Party: Claude Pichonnaz/ HES-professor and physiotherapist, HECVSanté (University of Applied Sciences in Health)
ClinicalTrials.gov Identifier: NCT00711711     History of Changes
Other Study ID Numbers: FNS-DORE 13DPD3-120298, SAGEX: 21267, RéSaR 10/O/07, Ré-Sa-R 13-07
Study First Received: July 8, 2008
Last Updated: April 13, 2011
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by Haute Ecole Cantonale Vaudoise de Santé:
Physical Therapy - Therapeutics - Edema
Arthroplasty replacement knee
Treatment outcome

ClinicalTrials.gov processed this record on May 23, 2013