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Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

H

Haute Ecole de Santé Vaud

Status

Completed

Conditions

Knee Arthroplasty, Total

Treatments

Other: relaxation
Other: Manual lymphatic drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT00711711
FNS-DORE 13DPD3-120298
RéSaR 10/O/07 (Other Identifier)
Ré-Sa-R 13-07 (Other Identifier)
SAGEX: 21267 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Manual lymphatic drainage
Experimental group
Description:
this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery
Treatment:
Other: Manual lymphatic drainage
Relaxation
Placebo Comparator group
Description:
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery
Treatment:
Other: relaxation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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