Knee ArthroplastyNCT05457686
The Efficacy of Kinesiotaping on Pain, Edema and Functionality After Total Knee Arthroplasty
A study testing kinesio tape and Exercise in people with Knee Arthroplasty and Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In this prospective, randomized controlled trial; To evaluate the effect of kinesiology taping applied for edema on pain, edema and functions in the early period after total knee replacement.Patients who underwent total knee replacement will be included in the 10-day follow-up study.Patients will be divided into three… Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Knee Arthroplasty, Pain, Edema
- What is being tested?
- kinesio tape and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2022to 22 Feb 2023
- 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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performing total knee joint arthroplasty due to stage 4 gonarthrosis
- Agree to participate in the study
- Having signed the informed consent form
Who cannot join
- Presence of malignancy, infection, rheumatological disease
- Having a tape allergy
- Having a diagnosis of lymphedema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Kinesiology Taping After Total Knee Arthroplasty Surgery
In this prospective, randomized controlled trial; To evaluate the effect of kinesiology taping applied for edema on pain, edema and functions in the early period after total knee replacement.Patients who underwent total knee replacement will be included in the 10-day follow-up study.Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program.
In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group.
In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.
Read the detailed description
Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program.
In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group.
In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.
It is planned to prevent bias between the groups by giving standard analgesic treatment to all three groups in the postoperative period. In the postoperative period, Paracetamol 10 mg/ml Infusion 3*1, 100 mg tramadol hydrochloride tablet 2*1 and celecoxib capsule 100 mg 2*1 will be routinely administered until the discharge period.
Conservative postoperative physiotherapy program:
Conservative exercise program will be started on the second day after the surgery. All patients will receive an exercise program combined with a 20-minute local cold application once a day. Ankle pumping exercises, deep breathing exercises, isometric knee and hip circumference strengthening exercises, sitting by the bed, timed walking with a tolerable load on the prosthetic side will be recommended.
The number and frequency of exercises were gradually increased; isotonic knee and hip circumference strengthening exercises It will be added. After the drainage of the surgical wound is removed on the 2nd or 3rd day, the patients will be discharged on the 4th postoperative day. All patients will be informed about the conditions and activities that need attention. Patients who continue their home exercise program after discharge will be called for control on the 10th day.
Kinesio taping: In addition to its use in regional pain syndromes in recent years, KT application has also been reported in the literature after various non-orthopedic surgical procedures . Today, after KT application, which is widely used in orthopedics, especially in arthroscopic interventions, no negative effects have been observed on patients, and positive results have been reported, especially in the early period. The investigators aimed to compare this treatment method, which has been shown to be effective in studies performed after total knee arthroplasty, with SHAM taping and conservative postoperative physiotherapy program control group in a prospective randomized comparison.
Kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique in order to reduce edema and pain from the first postoperative day in the group receiving KT treatment.Accordingly, the proximal part of the tape will be placed close to the lymph node.In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching.Then 5-10% stretching is applied and the distal part is adhered.
The strips are applied as 2 separate bands crossing each other (from the medial and lateral of the knee).The patients will be taped with kinesio tape on the first day and the third day postoperatively, and they will be discharged on the fourth day.
After discharge, participant will be asked to remove the bands after 3 days as instructed.
SHAM taping: Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching.
Kinesiotaping application; It will be done by a physical therapist who has a kinesiology taping course certificate.
- Conditions
- Knee Arthroplasty, Pain, Edema
- Being tested
- kinesio tape, Sham taping, Exercise
- Keywords
- knee arthroplasty, kinesiotaping
- Medical subject headings
- Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio tapeOther
According to this, the proximal part of the band is located close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate tapes are applied so that the strips cross each other
Sham tapingOther
In the same procedure and time as kinesiotaping, inelastic tape will be used instead of kinesiotape.
ExerciseOther
Routine exercise and physiotherapy program applied after knee arthroplasty surgery will be applied
| Study group | Role | What they receive |
|---|---|---|
| kinesiology group | Experimental | In the group receiving kinesiology treatment, kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique from the first postoperative day to reduce edema and pain. Accordingly, the proximal part of the tape is placed close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate bands are applied so that the strips cross each other (from the medial and lateral of the knee). On the first postoperative day, on the third day, the patients will be taped with kinesio tape and discharged on the fourth day. After discharge, they will be asked to remove the tapes after 3 days as they were taught. Receives: Other: kinesio tape; Other: Exercise |
| sham taping group | Sham comparator | Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching. Receives: Other: Sham taping; Other: Exercise |
| only physical therapy group(control group) | Other | Conservative will be explained on the second day after the operation. Go for a visit with a local cold application 20 times once a day. Ankle pumping exercises, deep breathing exercises, isometric and hip exercises will be planned with a load that can be applied to students who are being applied for bed training.
Increased the number and allowance of exercises; isotonic knee and exercises that make you feel It will be added. You will be discharged on the 4th day after the surgery on the 2nd or 3rd day. You will do home exercises after discharge. On the 10th day, you will be called for control. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
edema
thigh, knee and leg diameter measurements to be measured with a tape measure
Measured: 1 day before surgery
edema
thigh, knee and leg diameter measurements to be measured with a tape measure
Measured: 1 days after surgery
edema
thigh, knee and leg diameter measurements to be measured with a tape measure
Measured: 3 days after surgery
edema
thigh, knee and leg diameter measurements to be measured with a tape measure
Measured: 10 days after surgery
Secondary outcomes (4)
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: 1 day before surgery
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: 1 day after surgery
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: 3 days after surgery
Pain Intensity
Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start14 Jul 2022
- Primary completion12 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Model description
- randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Fevzi Cakmak, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457686
- Sponsor's protocol ID
- 2022-08/87
- Status last verified
- Feb 2023
- First submitted
- 3 Jul 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boguszewski D, Tomaszewska I, Adamczyk JG, Bialoszewski D. Evaluation of effectiveness of kinesiology taping as an adjunct to rehabilitation following anterior cruciate ligament reconstruction. Preliminary report. Ortop Traumatol Rehabil. 2013 Oct 31;15(5):469-78. doi: 10.5604/15093492.1084361.
PubMed 24431257Jongbloed L, van Twist D, Swart N. Kinesio Taping Improves Pain, Range of Motion, and Proprioception in Older Patients With Knee Osteoarthritis. Am J Phys Med Rehabil. 2016 Jan;95(1):e7. doi: 10.1097/PHM.0000000000000393. No abstract available.
PubMed 26390398Guney Deniz H, Kinikli G, Onal S, et al THU0727-HPR Comparison of kinesio tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty Annals of the Rheumatic Diseases 2018;77:1791.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Kinesiology Taping After Total Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT05457686
- Acronym / sponsor ID
- 2022-08/87
- Conditions
- Knee Arthroplasty, Pain, Edema
- Keywords
- knee arthroplasty, kinesiotaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 14 Jul 2022 (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.
In this prospective, randomized controlled trial; To evaluate the effect of kinesiology taping applied for edema on pain, edema and functions in the early period after total knee replacement.Patients who underwent total knee replacement will be included in the 10-day follow-up study.Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program.
In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group.
In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.
Detailed description
Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program.
In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group.
In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.
It is planned to prevent bias between the groups by giving standard analgesic treatment to all three groups in the postoperative period. In the postoperative period, Paracetamol 10 mg/ml Infusion 3*1, 100 mg tramadol hydrochloride tablet 2*1 and celecoxib capsule 100 mg 2*1 will be routinely administered until the discharge period.
Conservative postoperative physiotherapy program:
Conservative exercise program will be started on the second day after the surgery. All patients will receive an exercise program combined with a 20-minute local cold application once a day. Ankle pumping exercises, deep breathing exercises, isometric knee and hip circumference strengthening exercises, sitting by the bed, timed walking with a tolerable load on the prosthetic side will be recommended.
The number and frequency of exercises were gradually increased; isotonic knee and hip circumference strengthening exercises It will be added. After the drainage of the surgical wound is removed on the 2nd or 3rd day, the patients will be discharged on the 4th postoperative day. All patients will be informed about the conditions and activities that need attention. Patients who continue their home exercise program after discharge will be called for control on the 10th day.
Kinesio taping: In addition to its use in regional pain syndromes in recent years, KT application has also been reported in the literature after various non-orthopedic surgical procedures . Today, after KT application, which is widely used in orthopedics, especially in arthroscopic interventions, no negative effects have been observed on patients, and positive results have been reported, especially in the early period. The investigators aimed to compare this treatment method, which has been shown to be effective in studies performed after total knee arthroplasty, with SHAM taping and conservative postoperative physiotherapy program control group in a prospective randomized comparison.
Kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique in order to reduce edema and pain from the first postoperative day in the group receiving KT treatment.Accordingly, the proximal part of the tape will be placed close to the lymph node.In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching.Then 5-10% stretching is applied and the distal part is adhered.
The strips are applied as 2 separate bands crossing each other (from the medial and lateral of the knee).The patients will be taped with kinesio tape on the first day and the third day postoperatively, and they will be discharged on the fourth day.
After discharge, participant will be asked to remove the bands after 3 days as instructed.
SHAM taping: Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching.
Kinesiotaping application; It will be done by a physical therapist who has a kinesiology taping course certificate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| kinesiology group | Experimental | Other: kinesio tape, Other: ExerciseIn the group receiving kinesiology treatment, kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique from the first postoperative day to reduce edema and pain. Accordingly, the proximal part of the tape is placed close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate bands are applied so that the strips cross each other (from the medial and lateral of the knee). On the first postoperative day, on the third day, the patients will be taped with kinesio tape and discharged on the fourth day. After discharge, they will be asked to remove the tapes after 3 days as they were taught. |
| sham taping group | Sham comparator | Other: Sham taping, Other: ExerciseSham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching. |
| only physical therapy group(control group) | Other | Other: ExerciseConservative will be explained on the second day after the operation. Go for a visit with a local cold application 20 times once a day. Ankle pumping exercises, deep breathing exercises, isometric and hip exercises will be planned with a load that can be applied to students who are being applied for bed training. Increased the number and allowance of exercises; isotonic knee and exercises that make you feel It will be added. You will be discharged on the 4th day after the surgery on the 2nd or 3rd day. You will do home exercises after discharge. On the 10th day, you will be called for control. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Performing total knee joint arthroplasty due to stage 4 gonarthrosis
- Agree to participate in the study
- Having signed the informed consent form
Key exclusion criteria (3 listed)
- Presence of malignancy, infection, rheumatological disease
- Having a tape allergy
- Having a diagnosis of lymphedema
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 |
|---|---|---|
| kinesio tapeAccording to this, the proximal part of the band is located close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate tapes are applied so that the strips cross each other | Other | kinesiology group |
| Sham tapingIn the same procedure and time as kinesiotaping, inelastic tape will be used instead of kinesiotape. | Other | sham taping group |
| ExerciseRoutine exercise and physiotherapy program applied after knee arthroplasty surgery will be applied | Other | kinesiology group, only physical therapy group(control group), sham taping group |
Primary outcome
edema
Time frame: 1 day before surgery
thigh, knee and leg diameter measurements to be measured with a tape measure
edema
Time frame: 1 days after surgery
thigh, knee and leg diameter measurements to be measured with a tape measure
edema
Time frame: 3 days after surgery
thigh, knee and leg diameter measurements to be measured with a tape measure
edema
Time frame: 10 days after surgery
thigh, knee and leg diameter measurements to be measured with a tape measure
4 secondary outcomes
Pain Intensity
Time frame: 1 day before surgery
Pain Intensity
Time frame: 1 day after surgery
Pain Intensity
Time frame: 3 days after surgery
Pain Intensity
Time frame: 10 days 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 23 Feb 2023.
- Background: PubMed 24431257Boguszewski D, Tomaszewska I, Adamczyk JG, Bialoszewski D. Evaluation of effectiveness of kinesiology taping as an adjunct to rehabilitation following anterior cruciate ligament reconstruction. Preliminary report. Ortop Traumatol Rehabil. 2013 Oct 31;15(5):469-78. doi: 10.5604/15093492.1084361.
- Background: PubMed 26390398Jongbloed L, van Twist D, Swart N. Kinesio Taping Improves Pain, Range of Motion, and Proprioception in Older Patients With Knee Osteoarthritis. Am J Phys Med Rehabil. 2016 Jan;95(1):e7. doi: 10.1097/PHM.0000000000000393. No abstract available.
- BackgroundGuney Deniz H, Kinikli G, Onal S, et al THU0727-HPR Comparison of kinesio tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty Annals of the Rheumatic Diseases 2018;77:1791.
- 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.
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 kinesio tape and Exercise in people with Knee Arthroplasty and Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
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 23 Feb 2023. 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 Turkey (Türkiye). 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?
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?
edema (time frame: 1 day before surgery). The study lists 4 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 NCT05457686, which also lists 3 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 23 Feb 2023.