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| ID | Type | Description | Link |
|---|---|---|---|
| SAGEX: 21267 | Other Identifier | HES-SO | |
| RéSaR 10/O/07 | Other Identifier | HES-SO | |
| Ré-Sa-R 13-07 | Other Identifier | HES-SO |
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| Name | Class |
|---|---|
| University of Applied Sciences of Western Switzerland | OTHER |
| University of Lausanne Hospitals | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual lymphatic drainage | Experimental | this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery |
|
| Relaxation | Placebo Comparator | This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual lymphatic drainage | Other | Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | presurgery, and 2 days, 7 days and 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude Pichonnaz, physiother | Haute Ecole Cantonale Vaudoise de Santé + Département de l'Appareil Locomoteur - CHUV | Principal Investigator |
| Brigitte M Jolles, PD MER MSc | Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de l'Appareil Locomoteur - CHUV | Lausanne | 1005 | Switzerland | |||
| Haute Ecole Cantonale Vaudoise de Santé |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26829760 | Derived | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Lymphatic Drainage | This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery |
| FG001 | Relaxation | This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Lymphatic Drainage | This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery |
| BG001 | Relaxation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | At day 7, 3 patients lost at follow up in the control group and 1 in the treatment group. At 3 months, 3 more patients lost at follow up in the control group. | Posted | Mean | Standard Deviation | percentage difference between limbs | presurgery, 2 days, 7 days and 3 months post surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Lymphatic Drainage | This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Claude Pichonnaz | HECVSanté | ++41213168126 | claude.pichonnaz@hesav.ch |
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| ID | Term |
|---|---|
| D000073297 | Manual Lymphatic Drainage |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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| relaxation | Other | Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery |
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| Lausanne |
| 1011 |
| Switzerland |
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Patients who received manual lymphatic drainage as the study intervention
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| Primary | 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. | At day 7, 3 patients lost at follow up in the control group and 1 in the treatment group. At 3 months, 3 more patients lost at follow up in the control group. | Posted | Mean | Standard Deviation | percentage difference between limbs | presurgery, and 2 days, 7 days and 3 months after surgery |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Relaxation | This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery | 0 | 30 | 0 | 30 | 0 | 30 |
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| D013812 |
| Therapeutics |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| Limb volume difference at day 2 (%) |
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| Limb volume difference at day 7 (%) |
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| Limb volume difference at 3 months (%) |
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