Total Knee ArthroplastyNCT04164927
The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema
A study testing Manual Lymphatic Drainage and Kinesio Taping in people with Total Knee Arthroplasty and Edema, run by Hacettepe University.
Trial summary
Significant trauma and muscular tightness often result during Total Knee Arthroplasty (TKA) surgery and thus act to restrict tissue fluid movement resulting with lower extremity edema. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Total Knee Arthroplasty, Edema, Exercise
- What is being tested?
- Manual Lymphatic Drainage and Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TKA surgery
Who cannot join
- active infection
- malignant tumor
- major cardiac pathology, or thrombus or venous obstruction that was pre-diagnosed or revealed on a routine preadmission hospital screening
About this study
Official title: The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema and Functional Outcomes in Patients With Total Knee Arthroplasty
Significant trauma and muscular tightness often result during Total Knee Arthroplasty (TKA) surgery and thus act to restrict tissue fluid movement resulting with lower extremity edema. Kinesio Taping® is applied directly on the skin for restoration of normal fluid perfusion, removing congestion of lymphatic fluid or hemorrhages. In addition Manual Lymphatic Drainage (MLD) enhances blood circulation and stimulates the lymphatic movement and unblocks lymphatic territories. The aim of the study was to investigate the effectiveness of Kinesio Taping® and MLD in reducing postoperative edema and pain in the early stage after TKA.
Read the detailed description
Procedures: Patients who underwent unilateral TKA were randomized as Kinesio Taping® group, MLD group and control group. For all patients, postoperative rehabilitation program included early mobilization and physical therapy twice a day during the stay in orthopedic traumatology department. On the second day after surgery, lymphatic correction method was used on the Kinesio Taping® group patients and a standardized 30-minute MLD treatment was applied to the MLD group patients. Control group received only physiotherapy treatment. Circumference measurements were applied on preoperatively and the second, third, fourth day and 6th weeks after surgery. Knee Injury and Osteoarthritis Outcome Score (KOOS) was used to determine the functional outcomes on the 6th weeks after surgery. Repeated measures of variance analysis was used to determine time differences between groups.
- Conditions
- Total Knee Arthroplasty, Edema, Exercise
- Being tested
- Manual Lymphatic Drainage, Kinesio Taping, Control
- Medical subject headings
- Edema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic DrainageOther
- Lymphatic correction method was used via the KinesioTaping® to patients group.
- Standardized 30-minute Manuel Lymphatic Drainage treatment was applied to the MLD group.
- Control group received only physiotherapy treatment.
Kinesio TapingOther
Depending on the size of the leg two or three fan cut tapes were applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Kinesio taping was applied by certified Kinesio Tape practitioner once a week to Kinesiotaping group.
ControlOther
Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. These exercises were undertaken in sets of 10 repetitions, 3 times daily; the physiotherapist was present to assist, as required, on 2 occasions per day for the first 3 postoperative days and then once daily from day 4 until hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping | Active comparator | Lymphatic correction method is applied via Kinesiotaping depending on the size of the leg two or three fan-cut tape was applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Certified Kinesio Tape practitioner applied Kinesiotaping on the second day (day 2) post-surgery and once a week. Receives: Other: Manual Lymphatic Drainage; Other: Control |
| Manual Lymphatic Drainage | Active comparator | A standardized 30-minute manual lymphatic drainage (MLD) treatment is applied to MLD group. On the second day (day 2) post-surgery, patients allocated to the MLD group underwent a standardized 30 minute MLD treatment on the operated limb by an experienced remedial massage therapist trained in delivering MLD. Receives: Other: Kinesio Taping; Other: Control |
| Control | No intervention | Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumference measurements
Circumference measurements
Measured: This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
Secondary outcomes (1)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates the functional status of knee joint. total points range between 0-100 points. higher points represents a better outcome. total score is the averaged subscales.
Measured: This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2015
- Primary completion30 Aug 2015
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE GUNEY, Hacettepe University
- Investigators
- Hande Güney Deniz, assoc. prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164927
- Sponsor's protocol ID
- GO15-152
- Status last verified
- Nov 2019
- First submitted
- 14 Jun 2018
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 26829760Ebert JR, Joss B, Jardine B, Wood DJ. Randomized trial investigating the efficacy of manual lymphatic drainage to improve early outcome after total knee arthroplasty. Arch Phys Med Rehabil. 2013 Nov;94(11):2103-11. doi: 10.1016/j.apmr.2013.06.009. Epub 2013 Jun 26.
PubMed 23810354
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema and Functional Outcomes in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04164927
- Acronym / sponsor ID
- GO15-152
- Conditions
- Total Knee Arthroplasty, Edema, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Aug 2015 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 15 Nov 2019 (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.
Significant trauma and muscular tightness often result during Total Knee Arthroplasty (TKA) surgery and thus act to restrict tissue fluid movement resulting with lower extremity edema. Kinesio Taping® is applied directly on the skin for restoration of normal fluid perfusion, removing congestion of lymphatic fluid or hemorrhages. In addition Manual Lymphatic Drainage (MLD) enhances blood circulation and stimulates the lymphatic movement and unblocks lymphatic territories. The aim of the study was to investigate the effectiveness of Kinesio Taping® and MLD in reducing postoperative edema and pain in the early stage after TKA.
Detailed description
Procedures: Patients who underwent unilateral TKA were randomized as Kinesio Taping® group, MLD group and control group. For all patients, postoperative rehabilitation program included early mobilization and physical therapy twice a day during the stay in orthopedic traumatology department. On the second day after surgery, lymphatic correction method was used on the Kinesio Taping® group patients and a standardized 30-minute MLD treatment was applied to the MLD group patients. Control group received only physiotherapy treatment. Circumference measurements were applied on preoperatively and the second, third, fourth day and 6th weeks after surgery. Knee Injury and Osteoarthritis Outcome Score (KOOS) was used to determine the functional outcomes on the 6th weeks after surgery. Repeated measures of variance analysis was used to determine time differences between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping | Active comparator | Other: Manual Lymphatic Drainage, Other: ControlLymphatic correction method is applied via Kinesiotaping depending on the size of the leg two or three fan-cut tape was applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Certified Kinesio Tape practitioner applied Kinesiotaping on the second day (day 2) post-surgery and once a week. |
| Manual Lymphatic Drainage | Active comparator | Other: Kinesio Taping, Other: ControlA standardized 30-minute manual lymphatic drainage (MLD) treatment is applied to MLD group. On the second day (day 2) post-surgery, patients allocated to the MLD group underwent a standardized 30 minute MLD treatment on the operated limb by an experienced remedial massage therapist trained in delivering MLD. |
| Control | No intervention | –Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- TKA surgery
Key exclusion criteria (3 listed)
- active infection
- malignant tumor
- major cardiac pathology, or thrombus or venous obstruction that was pre-diagnosed or revealed on a routine preadmission hospital screening
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 Drainage1. Lymphatic correction method was used via the KinesioTaping® to patients group. 2. Standardized 30-minute Manuel Lymphatic Drainage treatment was applied to the MLD group. 3. Control group received only physiotherapy treatment. | Other | Kinesio Taping |
| Kinesio TapingDepending on the size of the leg two or three fan cut tapes were applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Kinesio taping was applied by certified Kinesio Tape practitioner once a week to Kinesiotaping group. | Other | Manual Lymphatic Drainage |
| ControlKnee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. These exercises were undertaken in sets of 10 repetitions, 3 times daily; the physiotherapist was present to assist, as required, on 2 occasions per day for the first 3 postoperative days and then once daily from day 4 until hospital discharge. | Other | Kinesio Taping, Manual Lymphatic Drainage |
Primary outcome
Circumference measurements
Time frame: This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
Circumference measurements
1 secondary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
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 15 Nov 2019.
- Background: 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.
- Background: PubMed 23810354Ebert JR, Joss B, Jardine B, Wood DJ. Randomized trial investigating the efficacy of manual lymphatic drainage to improve early outcome after total knee arthroplasty. Arch Phys Med Rehabil. 2013 Nov;94(11):2103-11. doi: 10.1016/j.apmr.2013.06.009. Epub 2013 Jun 26.
- 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.
Hande Güney Deniz, assoc. prof. principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage and Kinesio Taping in people with Total Knee Arthroplasty and Edema, run by Hacettepe University.
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 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Circumference measurements (time frame: This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery). 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 NCT04164927, which also lists 2 linked publications.
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 15 Nov 2019.