TOTAL KNEE ARTHROPLASTYLINFOTAPENCT03452995
Lymphodreinage Integrated With Kinesio Tape in TKA Patients
A study testing PHYSIOTHERAPY in people with TOTAL KNEE ARTHROPLASTY and Edema Secondary, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Aim of the study: To evaluate the efficacy of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint ROM in patients undergoing surgery of total knee arthroplasty in osteoarthritis. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- TOTAL KNEE ARTHROPLASTY, Edema Secondary, Pain
- What is being tested?
- PHYSIOTHERAPY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2017to 31 Mar 2019
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery
- Patients of both sexes aged between 65 and 85;
- Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3cm.
Who cannot join
- Patients operated for re-implantation or revision
- Presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies.
- Absence of DVT of the lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Lymphatic Drainage Integrated With Kinesio Tape and Traditional Rehabilitation Techniques in Patients Operated for Knee Arthroplasty in Osteoarthritis
Aim of the study: To evaluate the efficacy of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint ROM in patients undergoing surgery of total knee arthroplasty in osteoarthritis.
Inclusion criteria: Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery, Patients of both sexes aged between 65 and 85, Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3 cm.
Read more
Exclusion criteria: Patients operated for re-implantation or revision, presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies, absence of DVT of the lower limb.
Study design: Prospective, open, randomized, lasting 12 months GROUP 1 (33 pts) KINESIOTAPING + STANDARD REHABILITATION GROUP 2 (33 pts) LYMPHODRAINAGE+ STANDARD REHABILITATION GROUP 3 (33 pts) KINESIOTAPING + LYMPHODRAINAGE + STANDARD REHABILITATION Outcome measures: Pain: evaluation with NRS scale 0-10, Edema: cirtometric evaluation (in 4 standard points), ROM: goniometric measurement of the knee joint excursion. All measures at the beginning and end of treatment (6 days).
Read the detailed description
Background In the days following knee arthroplasty, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, sometimes it can take longer, and sometimes result in a condition of chronic inflammation, albeit modest, that lasts for years. Lymphodrainage and Kinesiotaping have been indicated as effective treatments to reduce edema and alleviate pain. However it is not clear which of these techniques is more effective and if their effectiveness increases when combined.
Objective of the study The objective of the study is to evaluate the effectiveness of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint excursion (ROM) in patients undergoing total arthroplasty knee in osteoarthritis. The hypothesis is that the associated treatment of kinesiotaping and lymphatic drainage produces better results than the individual treatments.
Methods
Patients will be divided in 3 groups according to the type of treatment:
GROUP 1 Lymphatic drainage + standard rehabilitation GROUP 2 Kinesiotaping + standard rehabilitation GROUP 3 Lymphatic drainage + Kinesiotaping + standard rehabilitation For each patient the duration of the study will be 6 days, the total duration of the study will be 12 months.
Statistics Considering the NRS for the evaluation of pain as a primary outcome, the determination of the sample was made on the basis of the following assumptions: level of significance (α) = 0.05, (2) type 2 error (β) = 0.2; with an 80% test power ,.
For the calculation of the sample G * Power 3.1.7 was used based on an effect size of 0.8 (Large effect size according to Cohen) and the Bonferroni correction for multiple comparisons. The calculated dimension of the sample was thus determined of 30 patients per group. Considering a drop-out of 10% the total sample should be 99 patients (33 per group). All continuous variables will be expressed in terms of mean ± standard deviation (SD) and range. To analyze the data collected, one-way analysis will be used with a post hoc comparison test for paired Sidak data. Statistical analysis will be performed with SAS / Stat software (version 9.3; SAS Institute, Cary, North Carolina). For all tests a P <0.05 will be considered significant.
Treatment All enrolled patients will receive a standard rehabilitation treatment consisting of
- KINETEC 1 h / day
- Functional rehabilitation 30 min for 2 times/day
- Walking training 15 min for 2 times/day
For each of the three groups experimental treatments will be added
GROUP 1 Lymphodrainage + elastic containment (postoperative compression stockings), 3 treatments: in the second postoperative day, in 4th postoperative day and in 6th post-operative day
GROUP 2 Kinesiotaping, 3 treatments: in the second postoperative day, in 4th postoperative day and in 6th post-operative day
GROUP 3 Lymphodrainage and Kinesiotaping, 3 treatments: on the second post-operative day, on 4 days post-operative and on the 6th post-operative day
The Vodder massage technique will be used for lymphatic drainage. The peculiarity of this method is the absolute respect of the lymphatic directions, of the operative pressures, of the frequency, of the rhythm and of the gesture. The various manoevers on the different body districts are performed in a proximal-distal sense, to respect the lymphatic course in directions of the lymph node stations and are performed with harmonic, slow and rhythmic movements. Manual pressures should not exceed 30-40 mmHg, but may vary depending on the consistency of the edema. In the specific case of the project, drainage is followed in the lower limb of the anterior and posterior part by placing the neck ganglia empty, which is peculiar to the original Volder method, used for about 30 minutes.
As for the Kinesiotaping as a lymphatic application the fan technique applied in the back of the thigh and the leg, and in the front of the foot (back of the foot) will be used with the aim of activating the cutaneous mechanoreceptors, reduce the pressure at the level interstitial in order to promote lymphatic drainage and ensure that this application leads to the reduction of swelling of post-operative soft tissues.
Adverse events The expected techniques do not foresee adverse events therefore, considering the good tolerance of the patients and the scarcity of known contraindications, we can state that the treatment is safe and can be an additional measure for pain reduction as well as edema. However, it is possible that the areas treated with neuromuscular tape may show skin irritations caused by the glue of the tape in case of very delicate skin.
- Conditions
- TOTAL KNEE ARTHROPLASTY, Edema Secondary, Pain, Joint Dysfunction
- Being tested
- PHYSIOTHERAPY
- Medical subject headings
- Pain, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSIOTHERAPYProcedure or surgery
Also called Lymphodreinage, kinesiotaping
Lymphodreinage and kinesiotaping are current methods of treatment of edema, pain and indirectly recovery of the knee ROM in TKA. Edema, pain and knee ROM are strictly corelated and, by reducing edema, we reduce the pressure by relieving pain, and allowing an improvement in movement.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy: LYMPHO DRAINAGE | Active comparator | Patients will be treated on the second postoperative day, on the 4th postoperative day and on the 6th post-operative day by means of Manual lymphodrainage consisting in special massage technique that allows lymphatic drainage, or removal of interstitial fluid stagnation according to Vodder, in association to the standard rehabilitation protocol for TKA (Kinetec, functional rehabilitation and walking training Receives: Procedure: PHYSIOTHERAPY |
| Physiotherapy: KINESIOTAPING | Active comparator | Patients will be treated on the second postoperative day, on the 4th postoperative day and on the 6th post-operative day through the use of patches acting through the sensory system giving stimuli to receptors on the skin, in association to the standard rehabilitation protocol for TKA (kinetec, functional rehabilitation and walking training . Receives: Procedure: PHYSIOTHERAPY |
| Physiotherapy:LYMPHO+KINESIO | Experimental | Patients will ne treated with both kinesiotaping and lymphodreinage on the second post-operative day, on 4 days post-operative and on the 6th post-operative day, in association to the standard rehabilitation protocol for TKA (kinetec, functional rehabilitation and walking training Receives: Procedure: PHYSIOTHERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
NRS Pain: the Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain.
Pain Level rating:
0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-10 Severe Pain
Measured: Change between baseline and the end of treatment (6 days)
Secondary outcomes (2)
Edema
cirtometric evaluation (in 3 standard points (above the knee: 10 cm above the upper patellar pole, 10 cm below the inferior patellar pole, ankle).
Measured: Change between baseline and the end of treatment (6 days)
KNEE ROM
goniometric measurement of the knee joint excursion operated at the beginning and end of treatment
Measured: Change between baseline and the end of treatment (6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start30 Nov 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TOTAL KNEE ARTHROPLASTYStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Tornatore, Istituto Ortopedico Rizzoli
- Investigators
- Laura Tornatore, PT, Principal investigator, Istituto Ortopedico Rizzoli DRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452995
- Sponsor's protocol ID
- 0009494
- Acronym
- LINFOTAPE
- Status last verified
- Jan 2020
- First submitted
- 20 Feb 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Lymphatic Drainage Integrated With Kinesio Tape and Traditional Rehabilitation Techniques in Patients Operated for Knee Arthroplasty in Osteoarthritis
- ClinicalTrials.gov ID
- NCT03452995
- Acronym / sponsor ID
- LINFOTAPE / 0009494
- Conditions
- TOTAL KNEE ARTHROPLASTY, Edema Secondary, Pain, Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 2 Mar 2018 (actual)
- 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.
Aim of the study: To evaluate the efficacy of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint ROM in patients undergoing surgery of total knee arthroplasty in osteoarthritis.
Inclusion criteria: Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery, Patients of both sexes aged between 65 and 85, Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3 cm.
Exclusion criteria: Patients operated for re-implantation or revision, presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies, absence of DVT of the lower limb.
Study design: Prospective, open, randomized, lasting 12 months GROUP 1 (33 pts) KINESIOTAPING + STANDARD REHABILITATION GROUP 2 (33 pts) LYMPHODRAINAGE+ STANDARD REHABILITATION GROUP 3 (33 pts) KINESIOTAPING + LYMPHODRAINAGE + STANDARD REHABILITATION Outcome measures: Pain: evaluation with NRS scale 0-10, Edema: cirtometric evaluation (in 4 standard points), ROM: goniometric measurement of the knee joint excursion. All measures at the beginning and end of treatment (6 days).
Detailed description
Background In the days following knee arthroplasty, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, sometimes it can take longer, and sometimes result in a condition of chronic inflammation, albeit modest, that lasts for years. Lymphodrainage and Kinesiotaping have been indicated as effective treatments to reduce edema and alleviate pain. However it is not clear which of these techniques is more effective and if their effectiveness increases when combined.
Objective of the study The objective of the study is to evaluate the effectiveness of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint excursion (ROM) in patients undergoing total arthroplasty knee in osteoarthritis. The hypothesis is that the associated treatment of kinesiotaping and lymphatic drainage produces better results than the individual treatments.
Methods
Patients will be divided in 3 groups according to the type of treatment:
GROUP 1 Lymphatic drainage + standard rehabilitation GROUP 2 Kinesiotaping + standard rehabilitation GROUP 3 Lymphatic drainage + Kinesiotaping + standard rehabilitation For each patient the duration of the study will be 6 days, the total duration of the study will be 12 months.
Statistics Considering the NRS for the evaluation of pain as a primary outcome, the determination of the sample was made on the basis of the following assumptions: level of significance (α) = 0.05, (2) type 2 error (β) = 0.2; with an 80% test power ,.
For the calculation of the sample G * Power 3.1.7 was used based on an effect size of 0.8 (Large effect size according to Cohen) and the Bonferroni correction for multiple comparisons. The calculated dimension of the sample was thus determined of 30 patients per group. Considering a drop-out of 10% the total sample should be 99 patients (33 per group). All continuous variables will be expressed in terms of mean ± standard deviation (SD) and range. To analyze the data collected, one-way analysis will be used with a post hoc comparison test for paired Sidak data. Statistical analysis will be performed with SAS / Stat software (version 9.3; SAS Institute, Cary, North Carolina). For all tests a P <0.05 will be considered significant.
Treatment All enrolled patients will receive a standard rehabilitation treatment consisting of
- KINETEC 1 h / day
- Functional rehabilitation 30 min for 2 times/day
- Walking training 15 min for 2 times/day
For each of the three groups experimental treatments will be added
GROUP 1 Lymphodrainage + elastic containment (postoperative compression stockings), 3 treatments: in the second postoperative day, in 4th postoperative day and in 6th post-operative day
GROUP 2 Kinesiotaping, 3 treatments: in the second postoperative day, in 4th postoperative day and in 6th post-operative day
GROUP 3 Lymphodrainage and Kinesiotaping, 3 treatments: on the second post-operative day, on 4 days post-operative and on the 6th post-operative day
The Vodder massage technique will be used for lymphatic drainage. The peculiarity of this method is the absolute respect of the lymphatic directions, of the operative pressures, of the frequency, of the rhythm and of the gesture. The various manoevers on the different body districts are performed in a proximal-distal sense, to respect the lymphatic course in directions of the lymph node stations and are performed with harmonic, slow and rhythmic movements. Manual pressures should not exceed 30-40 mmHg, but may vary depending on the consistency of the edema. In the specific case of the project, drainage is followed in the lower limb of the anterior and posterior part by placing the neck ganglia empty, which is peculiar to the original Volder method, used for about 30 minutes.
As for the Kinesiotaping as a lymphatic application the fan technique applied in the back of the thigh and the leg, and in the front of the foot (back of the foot) will be used with the aim of activating the cutaneous mechanoreceptors, reduce the pressure at the level interstitial in order to promote lymphatic drainage and ensure that this application leads to the reduction of swelling of post-operative soft tissues.
Adverse events The expected techniques do not foresee adverse events therefore, considering the good tolerance of the patients and the scarcity of known contraindications, we can state that the treatment is safe and can be an additional measure for pain reduction as well as edema. However, it is possible that the areas treated with neuromuscular tape may show skin irritations caused by the glue of the tape in case of very delicate skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy: LYMPHO DRAINAGE | Active comparator | Procedure: PHYSIOTHERAPYPatients will be treated on the second postoperative day, on the 4th postoperative day and on the 6th post-operative day by means of Manual lymphodrainage consisting in special massage technique that allows lymphatic drainage, or removal of interstitial fluid stagnation according to Vodder, in association to the standard rehabilitation protocol for TKA (Kinetec, functional rehabilitation and walking training |
| Physiotherapy: KINESIOTAPING | Active comparator | Procedure: PHYSIOTHERAPYPatients will be treated on the second postoperative day, on the 4th postoperative day and on the 6th post-operative day through the use of patches acting through the sensory system giving stimuli to receptors on the skin, in association to the standard rehabilitation protocol for TKA (kinetec, functional rehabilitation and walking training . |
| Physiotherapy:LYMPHO+KINESIO | Experimental | Procedure: PHYSIOTHERAPYPatients will ne treated with both kinesiotaping and lymphodreinage on the second post-operative day, on 4 days post-operative and on the 6th post-operative day, in association to the standard rehabilitation protocol for TKA (kinetec, functional rehabilitation and walking training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery
- Patients of both sexes aged between 65 and 85;
- Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3cm.
Key exclusion criteria (3 listed)
- Patients operated for re-implantation or revision
- Presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies.
- Absence of DVT of the lower limb.
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 |
|---|---|---|
| PHYSIOTHERAPYAlso: Lymphodreinage, kinesiotapingLymphodreinage and kinesiotaping are current methods of treatment of edema, pain and indirectly recovery of the knee ROM in TKA. Edema, pain and knee ROM are strictly corelated and, by reducing edema, we reduce the pressure by relieving pain, and allowing an improvement in movement. | Procedure or surgery | Physiotherapy: KINESIOTAPING, Physiotherapy: LYMPHO DRAINAGE, Physiotherapy:LYMPHO+KINESIO |
Primary outcome
Pain severity
Time frame: Change between baseline and the end of treatment (6 days)
NRS Pain: the Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. Pain Level rating: 0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-10 Severe Pain
2 secondary outcomes
Edema
Time frame: Change between baseline and the end of treatment (6 days)
KNEE ROM
Time frame: Change between baseline and the end of treatment (6 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- 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.
Laura Tornatore, PT principal investigator
Istituto Ortopedico Rizzoli DRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHYSIOTHERAPY in people with TOTAL KNEE ARTHROPLASTY and Edema Secondary, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 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 13 Jan 2020. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain severity (time frame: Change between baseline and the end of treatment (6 days)). 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 13 Jan 2020.