Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
Total Knee Joint Prosthesis
Other: Manual lymphatic drainage
|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|
- bioimpedance ratio healthy/operated [ Time Frame: presurgery, 2 days, 8 days and 3 months post surgery ] [ Designated as safety issue: No ]
- lower limb volume ratio operated/healthy [ Time Frame: presurgery, and 2 days, 8 days and 3 months after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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
Placebo Comparator: Relaxation
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711711
|Département de l'Appareil Locomoteur - CHUV|
|Lausanne, Switzerland, 1005|
|Haute Ecole Cantonale Vaudoise de Santé|
|Lausanne, Switzerland, 1011|
|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|