Total Knee ReplacementNCT01657149
Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement
A study testing Lymphatic massage and individual physiotherapy and individual physiotherapy only in people with Total Knee Replacement, run by Rabin Medical Center at 1 site in Israel.
Trial summary
To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Lymphatic massage and individual physiotherapy and individual physiotherapy only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary total knee replacement
- ages 50-85
- preserved cognitive facilities and comprehension.
Who cannot join
- Severe chronic heart failure.
- previous episode of lymph edema.
- surgical removal of lymph nodes in the lower limbs.
- significant scarring of the lower limbs (larger than 10 cm).
- Deterioration in a patient's medical condition or an infection of the lower limb during the trial period will also cause exclusion of that patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement - Randomized Control Trial.
To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement.
Read the detailed description
In the past few decades there has been a rise in the number of knee replacements performed due to degenerative arthritis. In general over the years the number of operations has risen while the age of the patients has gone down. The aim of these operations is to improve quality of life, alleviate pain and improve function.
Post operative complications can delay recovery and rehabilitation, lengthen hospitalization duration and in extreme cases lead to failure of the operation. These complications include infection, deep vein thrombosis, swelling and edema, pain, impairment of range of motion, muscle weakness and functional disability.
Reduction of post operative edema may help to speed up recovery after total knee replacement.
Recently an effective treatment has been found for lymphatic edema that appears after oncological operations that include removal of lymph nodes or due to blood vessel disorders. This treatment is administered by a physiotherapist and includes lymphatic drainage massage, compression bandaging and exercises.
This trial will examine the effect of lymphatic massage treatment on orthopedic patients to ascertain if the use of this technique can shorten the duration and improve the quality of the post operative rehabilitation and prevent other post operative complications. At the present time not enough research has been done in this field and it is necessary to continue to investigate the efficiency of the lymphatic treatment in acute orthopedic patients.
Aims To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement.
Methods This blind randomized trial will take place in the Sharon hospital in Petach Tikvah with the cooperation of the orthopedic surgeons. The patients will be randomized into two groups- each containing 15 patients. The research group will receive lymphatic massage and individual physiotherapy while the control group will receive individual physiotherapy only.
Methods In order to assess the effects of the treatment the primary measurement will be circumferential measurement of limb volume. The secondary measurements will be pain assessment according to the VAS scale, a functional assessment according to BI"TI and range of motion measured with an inclinometer .
The measurements will be taken once prior to hospitalization. During hospitalization the measurements will be taken daily including the day of the release home and one last measurement will be taken 6 weeks after the operation. All measurements are valid and reliable.
The trial is scheduled to last 3-4 months
- Conditions
- Total Knee Replacement
- Being tested
- Lymphatic massage and individual physiotherapy, individual physiotherapy only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic massage and individual physiotherapyProcedure or surgery
lymphatic massage and individual physiotherapy
individual physiotherapy onlyProcedure or surgery
individual physiotherapy only
| Study group | Role | What they receive |
|---|---|---|
| Research Group | Experimental | receive lymphatic massage and individual physiotherapy Receives: Procedure: Lymphatic massage and individual physiotherapy |
| Control group | Active comparator | receive individual physiotherapy only Receives: Procedure: individual physiotherapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumferential measurement of limb volume
Measured: The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op
Secondary outcomes (2)
Visual Analogue Scale (VAS) Inclinometer
Measured: VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op
Daily functional capacity Assessment
Measured: Daily functional capacity Assessment after 6 days post op. All Outcomes will be reassessed after 6 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: a cardinal member of The research team withdrawn from study, the study has beem terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657149
- Sponsor's protocol ID
- 0081-12-RMC
- Status last verified
- Aug 2015
- First submitted
- 15 Jul 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement - Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01657149
- Acronym / sponsor ID
- 0081-12-RMC
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: a cardinal member of The research team withdrawn from study, the study has beem terminated.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement.
Detailed description
In the past few decades there has been a rise in the number of knee replacements performed due to degenerative arthritis. In general over the years the number of operations has risen while the age of the patients has gone down. The aim of these operations is to improve quality of life, alleviate pain and improve function.
Post operative complications can delay recovery and rehabilitation, lengthen hospitalization duration and in extreme cases lead to failure of the operation. These complications include infection, deep vein thrombosis, swelling and edema, pain, impairment of range of motion, muscle weakness and functional disability.
Reduction of post operative edema may help to speed up recovery after total knee replacement.
Recently an effective treatment has been found for lymphatic edema that appears after oncological operations that include removal of lymph nodes or due to blood vessel disorders. This treatment is administered by a physiotherapist and includes lymphatic drainage massage, compression bandaging and exercises.
This trial will examine the effect of lymphatic massage treatment on orthopedic patients to ascertain if the use of this technique can shorten the duration and improve the quality of the post operative rehabilitation and prevent other post operative complications. At the present time not enough research has been done in this field and it is necessary to continue to investigate the efficiency of the lymphatic treatment in acute orthopedic patients.
Aims To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement.
Methods This blind randomized trial will take place in the Sharon hospital in Petach Tikvah with the cooperation of the orthopedic surgeons. The patients will be randomized into two groups- each containing 15 patients. The research group will receive lymphatic massage and individual physiotherapy while the control group will receive individual physiotherapy only.
Methods In order to assess the effects of the treatment the primary measurement will be circumferential measurement of limb volume. The secondary measurements will be pain assessment according to the VAS scale, a functional assessment according to BI"TI and range of motion measured with an inclinometer .
The measurements will be taken once prior to hospitalization. During hospitalization the measurements will be taken daily including the day of the release home and one last measurement will be taken 6 weeks after the operation. All measurements are valid and reliable.
The trial is scheduled to last 3-4 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research Group | Experimental | Procedure: Lymphatic massage and individual physiotherapyreceive lymphatic massage and individual physiotherapy |
| Control group | Active comparator | Procedure: individual physiotherapy onlyreceive individual physiotherapy only |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary total knee replacement
- ages 50-85
- preserved cognitive facilities and comprehension.
Key exclusion criteria (5 listed)
- Severe chronic heart failure.
- previous episode of lymph edema.
- surgical removal of lymph nodes in the lower limbs.
- significant scarring of the lower limbs (larger than 10 cm).
- Deterioration in a patient's medical condition or an infection of the lower limb during the trial period will also cause exclusion of that patient.
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 |
|---|---|---|
| Lymphatic massage and individual physiotherapylymphatic massage and individual physiotherapy | Procedure or surgery | Research Group |
| individual physiotherapy onlyindividual physiotherapy only | Procedure or surgery | Control group |
Primary outcome
Circumferential measurement of limb volume
Time frame: The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op
2 secondary outcomes
Visual Analogue Scale (VAS) Inclinometer
Time frame: VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op
Daily functional capacity Assessment
Time frame: Daily functional capacity Assessment after 6 days post op. All Outcomes will be reassessed after 6 weeks post op
Results and safety
The study was stopped early (reason given: a cardinal member of The research team withdrawn from study, the study has beem terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic massage and individual physiotherapy and individual physiotherapy only in people with Total Knee Replacement, run by Rabin Medical Center at 1 site in Israel.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. 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?
The study was stopped early (reason given: a cardinal member of The research team withdrawn from study, the study has beem terminated.). Results are not available in the source record.
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?
Circumferential measurement of limb volume (time frame: The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2016.