Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

• Sponsor: Haute Ecole de Santé Vaud (Other)
• Overall Status: Completed
• CT.gov ID: NCT00711711
• Collaborator: University of Applied Sciences of Western Switzerland (Other), University of Lausanne Hospitals (Other)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 33
• Patients Per Site: 30
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroplasty, Total	Other: Manual lymphatic drainage; Other: relaxation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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; Other Names: lymphatic drainage manual lymph drainage MLD
Placebo Comparator: Relaxation 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 of tape recorded relaxation , from day 2 to day 7 post surgery; Other Names: eriksonian hypnosis

Outcome Measures

Primary Outcome Measures

1. Bioimpedance Percentage Difference Healthy/Operated [presurgery, 2 days, 7 days and 3 months post surgery]

   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.

2. Lower Limb Volume Percentage Difference Operated/Healthy [presurgery, and 2 days, 7 days and 3 months after surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département de l'Appareil Locomoteur - CHUV	Lausanne		Switzerland	1005
2	Haute Ecole Cantonale Vaudoise de Santé	Lausanne		Switzerland	1011

Sponsors and Collaborators

• Haute Ecole de Santé Vaud
• University of Applied Sciences of Western Switzerland
• University of Lausanne Hospitals

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claude Pichonnaz, Associate professor, Haute Ecole de Santé Vaud
• ClinicalTrials.gov Identifier: NCT00711711
• Other Study ID Numbers: FNS-DORE 13DPD3-120298; SAGEX: 21267; RéSaR 10/O/07; Ré-Sa-R 13-07
• First Posted: Jul 9, 2008
• Last Update Posted: Jan 18, 2019
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Claude Pichonnaz, Associate professor, Haute Ecole de Santé Vaud: Physical Therapy - Therapeutics - Edema; Arthroplasty replacement knee; Treatment outcome

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Manual Lymphatic Drainage	Relaxation
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	30	30
Second Postsurgical Day	30	30
Seventh Postsurgical Day	29	27
COMPLETED	29	24
NOT COMPLETED	1	6

Baseline Characteristics

Arm/Group Title	Manual Lymphatic Drainage	Relaxation	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 76.7%	21 70%	44 73.3%
>=65 years	7 23.3%	9 30%	16 26.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (8.5)	70.1 (9.1)	70.7 (8.8)
Sex: Female, Male (Count of Participants)
Female	18 60%	21 70%	39 65%
Male	12 40%	9 30%	21 35%
Region of Enrollment (participants) [Number]
Switzerland	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Bioimpedance Percentage Difference Healthy/Operated
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Manual Lymphatic Drainage
Arm/Group Description	Patients who received relaxation as placebo intervention	Patients who received manual lymphatic drainage as the study intervention
Measure Participants	30	30
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Manual Lymphatic Drainage
	Comments	All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P<.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Lower Limb Volume Percentage Difference Operated/Healthy
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Manual Lymphatic Drainage	Relaxation
Arm/Group Description	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	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
Measure Participants	30	30
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Manual Lymphatic Drainage
	Comments	All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P<.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Manual Lymphatic Drainage		Relaxation
Arm/Group Description	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		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
All Cause Mortality
	Manual Lymphatic Drainage		Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Manual Lymphatic Drainage		Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Manual Lymphatic Drainage		Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.