Knee Arthroplasty, TotalNCT00711711
Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
A study testing Manual lymphatic drainage and relaxation in people with Knee Arthroplasty, Total, run by Haute Ecole de Santé Vaud at 2 sites in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Manual lymphatic drainage and relaxation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- knee replacement surgery
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Département de l'Appareil Locomoteur - CHUV
Lausanne, 1005
Haute Ecole Cantonale Vaudoise de Santé
Lausanne, 1011
About this study
Official title: Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
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
Read the 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.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Manual lymphatic drainage, relaxation
- Keywords
- Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymphatic drainageOther
Also called lymphatic drainage, manual lymph drainage, MLD
Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery
relaxationOther
Also called eriksonian hypnosis
Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery
| Study group | Role | What they receive |
|---|---|---|
| Manual lymphatic drainage | Experimental | this arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery Receives: Other: Manual lymphatic drainage |
| Relaxation | Placebo comparator | This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery Receives: Other: relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: presurgery, and 2 days, 7 days and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals
- Responsible party
- Principal investigator, Claude Pichonnaz, Haute Ecole de Santé Vaud
- Investigators
- Claude Pichonnaz, physiother, Principal investigator, Haute Ecole Cantonale Vaudoise de Santé + Département de l'Appareil Locomoteur - CHUVBrigitte M Jolles, PD MER MSc, Study director, Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711711
- Sponsor's protocol ID
- FNS-DORE 13DPD3-120298
- Other IDs
- SAGEX: 21267, RéSaR 10/O/07, Ré-Sa-R 13-07
- Status last verified
- Aug 2018
- First submitted
- 8 Jul 2008
- Last updated
- 18 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26829760
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT00711711
- Acronym / sponsor ID
- FNS-DORE 13DPD3-120298
- Conditions
- Knee Arthroplasty, Total
- Keywords
- Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals
- Study start
- Jun 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 18 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual lymphatic drainage | Experimental | Other: Manual lymphatic drainagethis arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery |
| Relaxation | Placebo comparator | Other: relaxationThis arm will receive 5 relaxation treatments from day 2 to day 7 post surgery |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- knee replacement surgery
Key exclusion criteria (11 listed)
- pacemaker
- cardiac defibrillator
- pathology of the lymphatic system
- lower limb impairment which interferes with gait
- neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual lymphatic drainageAlso: lymphatic drainage, manual lymph drainage, MLDEach patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery | Other | Manual lymphatic drainage |
| relaxationAlso: eriksonian hypnosisEach patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery | Other | Relaxation |
Primary outcome
Bioimpedance Percentage Difference Healthy/Operated
Time frame: 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.
Lower Limb Volume Percentage Difference Operated/Healthy
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26829760Pichonnaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Pichonnaz, physiother principal investigator
Haute Ecole Cantonale Vaudoise de Santé + Département de l'Appareil Locomoteur - CHUV
Brigitte M Jolles, PD MER MSc study director
Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymphatic drainage and relaxation in people with Knee Arthroplasty, Total, run by Haute Ecole de Santé Vaud at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioimpedance Percentage Difference Healthy/Operated (time frame: presurgery, 2 days, 7 days and 3 months post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.