An interventional study of Manual lymphatic drainage and relaxation in Knee Arthroplasty, Total, sponsored by Haute Ecole de Santé Vaud. Completed at 2 sites in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-01-18.
Sponsored by Haute Ecole de Santé Vaud · Not applicable, Interventional, and Treatment
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
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.
Haute Ecole de Santé Vaud is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery
Other: Manual lymphatic drainage
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 by a trained physiotherapist, from day 2 to day 7 post surgery
Also known as: lymphatic drainage, manual lymph drainage, MLD
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
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.
Time frame: 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.
Time frame: presurgery, and 2 days, 7 days and 3 months after surgery
Patients from the Department of Orthopedic and Traumatic Surgery of the University Hospital of Lausanne were recruited from July 1, 2008 to November 16, 2010
| Milestone | Manual Lymphatic Drainage | Relaxation |
|---|---|---|
| Started | 30 | 30 |
| Second postsurgical day | 30 | 30 |
| Seventh postsurgical day | 29 | 27 |
| Completed | 29 | 24 |
| Not completed | 1 | 6 |
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.
| percentage difference between limbs | Placebo | Manual Lymphatic Drainage |
|---|---|---|
| Baseline limb bioimpedance R0 difference (%) | 1.8 ± 5.0 | 0.2 ± 4.5 |
| Limb bioimpedance R0 difference at day 2 (%) | 12.9 ± 9.7 | 13.7 ± 72 |
| Limb bioimpedance R0 difference at day 7 (%) | 41.8 ± 6.5 | 40.8 ± 6.6 |
| Limb bioimpedance R0 difference at 3 months (%) | 16.6 ± 9.3 | 19.1 ± 11.0 |
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.
| percentage difference between limbs | Manual Lymphatic Drainage | Relaxation |
|---|---|---|
| Baseline limb volume difference (%) | 1.8 ± 5.0 | 0. ± 4.5 |
| Limb volume difference at day 2 (%) | 12.9 ± 9.7 | 13.7 ± 7.2 |
| Limb volume difference at day 7 (%) | 17.0 ± 10.7 | 15.3 ± 6.5 |
| Limb volume difference at 3 months (%) | 3.7 ± 5.7 | 4.1 ± 5.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Manual Lymphatic Drainage | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Relaxation | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Manual Lymphatic Drainage | Relaxation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 21 | 44 |
| >=65 years | 7 | 9 | 16 |
| Age, Continuous(years) | Manual Lymphatic Drainage | Relaxation | Total |
|---|---|---|---|
| Mean | 71.3 ± 8.5 | 70.1 ± 9.1 | 70.7 ± 8.8 |
| Sex: Female, Male(Participants) | Manual Lymphatic Drainage | Relaxation | Total |
|---|---|---|---|
| Female | 18 | 21 | 39 |
| Male | 12 | 9 | 21 |
| Region of Enrollment(participants) | Manual Lymphatic Drainage | Relaxation | Total |
|---|---|---|---|
| Switzerland | 30 | 30 | 60 |
Plan to share: No
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Haute Ecole de Santé Vaud