Knee OsteoarthritisNCT05226195
Effect of Kinesio® Taping in Total Knee Replacement Surgery
A study testing Sterile Kinesio Taping in people with Knee Osteoarthritis and Post-Surgical Complication, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Total knee replacement, which is the gold standard surgical treatment method applied in today's conditions, in order to maintain the patient's daily life without pain, to provide the knee joint range of motion, to eliminate the deformity and instability in the knee joint in advanced stage (Stage 3-4) knee… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Post-Surgical Complication
- What is being tested?
- Sterile Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2022to 1 Jun 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to be volunteered to participate in the study.
- It will be performed in patients who have stage 3-4 osteoarthritis according to the "Kellgren-Lawrence" classification and therefore undergo total knee replacement surgery in a ligament-cutting design in the Department of Orthopedics and Traumatology of Baskent University Ankara Hospital.
Who cannot join
- Patients who underwent total knee prosthesis surgery in a hinge-preserving and hinged design
- Patients who underwent simultaneous bilateral total knee prosthesis surgery
- Patients with lymphedema
- Skin lesions at the place where the taping will be applied
- Local sensitivity in the skin sensitivity test to be performed the day before the application
- Chronic kidney failure patients
Show all 12Show fewer
- Patients with congestive heart failure
- Patients with a body mass index of 30 and above
- Patients who underwent surgery for pathological fractures
- Patients who underwent total knee replacement revision surgery
- Patients who had previously undergone high tibial osteotomy or unicondylar knee replacement surgery
- Patients who underwent surgery due to traumatic arthrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kinesio® Taping on Post-Surgical Functional Outcomes in Patients Undergoing Total Knee Replacement Surgery
Total knee replacement, which is the gold standard surgical treatment method applied in today's conditions, in order to maintain the patient's daily life without pain, to provide the knee joint range of motion, to eliminate the deformity and instability in the knee joint in advanced stage (Stage 3-4) knee osteoarthritis (OA) that does not benefit from conservative treatment. Obtaining the best clinical outcome for the patient after surgery is only possible with the implementation of post-surgical physical therapy and rehabilitation programs.
Edema and pain occurring in the early post-surgical period prevent patients from moving freely, and as a result, the psychological state of the patients is also affected. With effective physiotherapy, besides relieving pain and edema, patients' sensorimotor performances, proprioceptive senses and body balances are restored, and thus the brain is taught how to maintain joint functions. For this reason, new physiotherapy methods are being developed every day for this purpose.
Read more
"Kinesio Taping" (KT) is one of the modern physiotherapy methods that has been widely used in sports orthopedics in recent years. It was developed by Kenzo Kase in 1973 and is used clinically to relieve pain and edema, and to increase motor function in musculoskeletal diseases. In this method, an adhesive cotton-based tape called kinesio tape is used. The elastic structure of this band, which allows it to extend 130-140% of its original length, similar to the skin, together with its three-dimensional "fingerprint" texture specific to the band, causes the formation of microfolds on the skin. The formation of these folds; It is known that it increases the proprioceptive perception of the related joint by stimulating skin mechanoreceptors. It also reduces the pressure under the skin and helps relieve pain by increasing lymphatic drainage. The Epidermis-Dermis-Fascia (EDF) taping method is a KB method that has been developed in recent years. It provides less tension and is more easily applied to painful areas. The narrow strips of the applied tape provide more stimulation in the most superficial tissues5. Although studies on the effect of other application methods on rehabilitation after knee replacement surgery are available in the literature, there is no study in the literature showing the effects of the EDF technique.
In this study, it is aimed to evaluate the effect of KT applied with EDF technique on clinical results in the early postoperative period in patients who have undergone total knee replacement surgery. The hypothesis of this study is; It was determined that "pain and edema decrease and functional gain increases in patients who underwent KT after total knee prosthesis surgery".
- Conditions
- Knee Osteoarthritis, Post-Surgical Complication
- Being tested
- Sterile Kinesio Taping
- Keywords
- Kinesiotape, Post-Surgical Functional Outcomes, Total Knee Replacement Surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile Kinesio TapingOther
The standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group in the operating room at the end of the surgery in a sterile manner according to the epidermis-dermis-fascia (EDF) technique previously described in the literature (without tension). Original KinesioTex® Tape will be used in the study. The day of taping will be considered as Day 0 and the tapes will be changed on the 4th day, the 7th day.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Sterile Kinesio tape application | Experimental | The standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months. Receives: Other: Sterile Kinesio Taping |
| Group 2: Control group | No intervention | The standard post-surgical protocol applied in our clinic will be applied to Group 2. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline at 15th, 45th and 90th days in Pain
Visual analogue scale will be used for pain assessment in rest, activity and sleep. The patient will be asked to define the severity of pain in a 10 cm line, from 0 to 10. 0 means no pain and 10 means unbearable pain.
Measured: The clinical evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Range of Motion Assessment
range of motion of knee flexion and extension will be measured with digital inclinometer
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Edema
edema will be made with measurement of the opposite extremity which will be compared with the tape measure
Measured: The evaluation will be made on the 15th, 45th and 90th days
Secondary outcomes (8)
Change from Baseline at 15th, 45th and 90th days in Complications
Complications such as superficial-deep skin infection or allergic reaction will be evaluated.
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Functional Assessment of knee
Functional scores before and after surgery will be assessed with Knee Society Score. The Knee Society Score (KSS) has two components (knee and function scores), each of which is scored separately from 0 to 100, with higher values indicating better outcomes.
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Functional Assessment for osteoarthritis.
Functional scores before and after surgery will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index Score. The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is a disease-specific, self administered, health measure developed to study patients with osteoarthritis in the hip or knee. The domains are pain, stiffness, physical function, social function and emotional function. Every question can be given five alternative answers, which means a total of 0-4 points. The maximum score in the Likert version is 20 points for pain, 8 for stiffness and 68 points for physical function. A maximum score of 100 points occurred when the patient had minimum pain, stiffness and optimal function.
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Thermographic measurement
Thermal changes in the skin will be assessed via a thermal camera at the knee region
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Interleukin 6 (IL-6)
Inflammatory markers in the blood such as Interleukin 6 (IL-6) will be assessed. The reported values for IL-6 in the blood of healthy people vary between 0 and 43.5 pg/ml.
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Sedimentation rate
Inflammatory markers in the blood such as Sedimentation rate, the rate at which they settle is measured as the number of millimeters of clear plasma present at the top of the column after one hour (mm/hr), will be assessed.
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as C-reactive protein (CRP)
Inflammatory markers in the blood such as C-reactive protein (CRP) will be assessed. CRP concentration is measured in mg/L
Measured: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Creatine Kinase (CK)
Inflammatory markers in the blood such as Creatine Kinase (CK) will be assessed. Normal range is 22 to 198 U/L (units per liter)
Measured: The evaluation will be made on the 15th, 45th and 90th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start13 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- Prospective randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Ozunlu Pekyavas, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226195
- Sponsor's protocol ID
- KA21/464
- Status last verified
- Jul 2023
- First submitted
- 13 Jan 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesio® Taping on Post-Surgical Functional Outcomes in Patients Undergoing Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT05226195
- Acronym / sponsor ID
- KA21/464
- Conditions
- Knee Osteoarthritis, Post-Surgical Complication
- Keywords
- Kinesiotape, Post-Surgical Functional Outcomes, Total Knee Replacement Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Feb 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.
Total knee replacement, which is the gold standard surgical treatment method applied in today's conditions, in order to maintain the patient's daily life without pain, to provide the knee joint range of motion, to eliminate the deformity and instability in the knee joint in advanced stage (Stage 3-4) knee osteoarthritis (OA) that does not benefit from conservative treatment. Obtaining the best clinical outcome for the patient after surgery is only possible with the implementation of post-surgical physical therapy and rehabilitation programs.
Edema and pain occurring in the early post-surgical period prevent patients from moving freely, and as a result, the psychological state of the patients is also affected. With effective physiotherapy, besides relieving pain and edema, patients' sensorimotor performances, proprioceptive senses and body balances are restored, and thus the brain is taught how to maintain joint functions. For this reason, new physiotherapy methods are being developed every day for this purpose.
"Kinesio Taping" (KT) is one of the modern physiotherapy methods that has been widely used in sports orthopedics in recent years. It was developed by Kenzo Kase in 1973 and is used clinically to relieve pain and edema, and to increase motor function in musculoskeletal diseases. In this method, an adhesive cotton-based tape called kinesio tape is used. The elastic structure of this band, which allows it to extend 130-140% of its original length, similar to the skin, together with its three-dimensional "fingerprint" texture specific to the band, causes the formation of microfolds on the skin. The formation of these folds; It is known that it increases the proprioceptive perception of the related joint by stimulating skin mechanoreceptors. It also reduces the pressure under the skin and helps relieve pain by increasing lymphatic drainage. The Epidermis-Dermis-Fascia (EDF) taping method is a KB method that has been developed in recent years. It provides less tension and is more easily applied to painful areas. The narrow strips of the applied tape provide more stimulation in the most superficial tissues5. Although studies on the effect of other application methods on rehabilitation after knee replacement surgery are available in the literature, there is no study in the literature showing the effects of the EDF technique.
In this study, it is aimed to evaluate the effect of KT applied with EDF technique on clinical results in the early postoperative period in patients who have undergone total knee replacement surgery. The hypothesis of this study is; It was determined that "pain and edema decrease and functional gain increases in patients who underwent KT after total knee prosthesis surgery".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sterile Kinesio tape application | Experimental | Other: Sterile Kinesio TapingThe standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months. |
| Group 2: Control group | No intervention | –The standard post-surgical protocol applied in our clinic will be applied to Group 2. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to be volunteered to participate in the study.
- It will be performed in patients who have stage 3-4 osteoarthritis according to the "Kellgren-Lawrence" classification and therefore undergo total knee replacement surgery in a ligament-cutting design in the Department of Orthopedics and Traumatology of Baskent University Ankara Hospital.
Key exclusion criteria (12 listed)
- Patients who underwent total knee prosthesis surgery in a hinge-preserving and hinged design
- Patients who underwent simultaneous bilateral total knee prosthesis surgery
- Patients with lymphedema
- Skin lesions at the place where the taping will be applied
- Local sensitivity in the skin sensitivity test to be performed the day before the application
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 |
|---|---|---|
| Sterile Kinesio TapingThe standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group in the operating room at the end of the surgery in a sterile manner according to the epidermis-dermis-fascia (EDF) technique previously described in the literature (without tension). Original KinesioTex® Tape will be used in the study. The day of taping will be considered as Day 0 and the tapes will be changed on the 4th day, the 7th day. | Other | Group 1: Sterile Kinesio tape application |
Primary outcome
Change from Baseline at 15th, 45th and 90th days in Pain
Time frame: The clinical evaluation will be made on the 15th, 45th and 90th days
Visual analogue scale will be used for pain assessment in rest, activity and sleep. The patient will be asked to define the severity of pain in a 10 cm line, from 0 to 10. 0 means no pain and 10 means unbearable pain.
Change from Baseline at 15th, 45th and 90th days in Range of Motion Assessment
Time frame: The evaluation will be made on the 15th, 45th and 90th days
range of motion of knee flexion and extension will be measured with digital inclinometer
Change from Baseline at 15th, 45th and 90th days in Edema
Time frame: The evaluation will be made on the 15th, 45th and 90th days
edema will be made with measurement of the opposite extremity which will be compared with the tape measure
8 secondary outcomes
Change from Baseline at 15th, 45th and 90th days in Complications
Time frame: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Functional Assessment of knee
Time frame: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Functional Assessment for osteoarthritis.
Time frame: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Thermographic measurement
Time frame: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Interleukin 6 (IL-6)
Time frame: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Sedimentation rate
Time frame: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as C-reactive protein (CRP)
Time frame: The evaluation will be made on the 15th, 45th and 90th days
Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Creatine Kinase (CK)
Time frame: The evaluation will be made on the 15th, 45th and 90th 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 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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 Sterile Kinesio Taping in people with Knee Osteoarthritis and Post-Surgical Complication, run by Baskent University 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 2 inclusion and 12 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 27 Jul 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. 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?
Change from Baseline at 15th, 45th and 90th days in Pain (time frame: The clinical evaluation will be made on the 15th, 45th and 90th days). The study lists 3 primary outcomes in all. 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 27 Jul 2023.