Clinical trial NCT00711711: Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
Official title: Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty, Total
Keywords: Physical Therapy - Therapeutics - Edema
Arthroplasty replacement knee
Treatment outcome
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences of Western Switzerland
name: University of Lausanne Hospitals
First posted: 2008-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Bioimpedance Percentage Difference Healthy/Operated
timeFrame: presurgery, 2 days, 7 days and 3 months post surgery
measure: Lower Limb Volume Percentage Difference Operated/Healthy
timeFrame: presurgery, and 2 days, 7 days and 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Département de l'Appareil Locomoteur - CHUV
city: Lausanne
country: Switzerland
facility: Haute Ecole Cantonale Vaudoise de Santé
Study officials:
affiliation: Haute Ecole Cantonale Vaudoise de Santé + Département de l'Appareil Locomoteur - CHUV
name: Claude Pichonnaz, physiother
role: PRINCIPAL_INVESTIGATOR
affiliation: Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
name: Brigitte M Jolles, PD MER MSc
role: STUDY_DIRECTOR
References:
citation: 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.