Knee OsteoarthritisNCT05847725
Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty
A study testing Elastic bandaging, Short stretch bandaging and Kinesio taping in people with Knee Osteoarthritis, run by Hacettepe University.
Trial summary
The study aimed to compare the effectiveness of elastic bandaging, Kinesio taping, and short stretch bandaging techniques on postoperative pain, edema, and functional level in the early stage after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Elastic bandaging, Short stretch bandaging and Kinesio taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years or older patients who had undergone unilateral TKA surgery for primary knee osteoarthritis, rheumatoid arthritis, and posttraumatic arthritis.
Who cannot join
- Body mass index greater than or equal to 35 kg/m2,
- Having a neurological or peripheral vascular disease,
- Having a contraindication condition for compression application (e.g., acute cellulitis, arterial insufficiency, unstable heart disease, acute deep vein thrombosis), and kinesio taping application (e.g., presence of active infectious, lymphedema and/ or cancer history)
About this study
Official title: Effects of Bandaging and Kinesiotaping® on Pain, Edema, and Functional Level in Patients With Total Knee Arthroplasty in the Early Postoperative Period: A Randomized Clinical Trial
The study aimed to compare the effectiveness of elastic bandaging, Kinesio taping, and short stretch bandaging techniques on postoperative pain, edema, and functional level in the early stage after total knee arthroplasty.
Read the detailed description
The study was conducted on 30 volunteer subjects who underwent unilateral total knee arthroplasty surgery. Thirty participants who underwent unilateral total knee arthroplasty were divided into the Elastic Bandage Group (n=10), Kinesio Tape group (n=10), and Short Stretch Bandage group (n=10). All treatments were stopped on the eighth day. All measurements taken preoperatively were repeated postoperative 1st, 3rd, 5th, 8th, 14th, 28th days, 6th week, and 3rd month. The functional level was measured in the sixth week and third month.
- Conditions
- Knee Osteoarthritis
- Being tested
- Elastic bandaging, Short stretch bandaging, Kinesio taping
- Keywords
- knee arthroplasty, edema, elastic bandages, short stretch bandages, kinesio tape
- Medical subject headings
- Osteoarthritis, Knee, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic bandagingOther
The bandages were wrapped circularly along the extremity from the toes to the groin, drawing an "8" at the ankle with a 50% overlap rate, starting with 80% tension and decreasing the pressure proximally.
Short stretch bandagingOther
Short tension bandage application was started on postoperative day 1 following the removal of the drains. According to the width of the extremity, using short tension bandages of 6, 8 and 10 cm width, starting from the sole of the foot, the first layer was wrapped circularly with 50% overlapping rate, 80% tension, and wrapped from the sole of the foot to the groin.
Kinesio tapingOther
Kinesio taping was applied in the form of a fan by cutting into 4 longitudinal pieces using the lymphatic correction technique with 15-20% tension, starting from the periphery of the inguinal lymph nodes on the medial, anterior and lateral of the leg, following the removal of the drains from the 1st post-op day.
| Study group | Role | What they receive |
|---|---|---|
| Elastic bandaging | Experimental | Patients who have undergone TKA for primary knee OA Receives: Other: Elastic bandaging |
| Short stretch bandaging | Experimental | Patients who have undergone TKA for primary knee OA Receives: Other: Short stretch bandaging |
| Kinesio taping | Experimental | Patients who have undergone TKA for primary knee OA Receives: Other: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain intensity, Minumum score 0: no pain, maximum score 10: worst pain
Measured: up to sixth weeks
Secondary outcomes (2)
Measuring Tape Measure
Edema
Measured: up to sixth weeks
The Knee Society Clinical Scoring System
Functional level assessment, maximum score 100, <60 poor, 60-69 average, 70-84 good, 85-100 excellent
Measured: up to sixth weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study startMay 2015
- Primary completionJun 2016
- Study completionDec 2016
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included a three parallel group of blinded evaluators. These cases were followed up with a planned follow-up program between preoperative and postoperative three months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gursoy Coskun, Hacettepe University
- Investigators
- Gürsoy Coşkun, Assoc. Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847725
- Sponsor's protocol ID
- HU-15/666-21
- Status last verified
- May 2023
- First submitted
- 1 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bandaging and Kinesiotaping® on Pain, Edema, and Functional Level in Patients With Total Knee Arthroplasty in the Early Postoperative Period: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05847725
- Acronym / sponsor ID
- HU-15/666-21
- Conditions
- Knee Osteoarthritis
- Keywords
- knee arthroplasty, edema, elastic bandages, short stretch bandages, kinesio tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 May 2023 (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.
The study aimed to compare the effectiveness of elastic bandaging, Kinesio taping, and short stretch bandaging techniques on postoperative pain, edema, and functional level in the early stage after total knee arthroplasty.
Detailed description
The study was conducted on 30 volunteer subjects who underwent unilateral total knee arthroplasty surgery. Thirty participants who underwent unilateral total knee arthroplasty were divided into the Elastic Bandage Group (n=10), Kinesio Tape group (n=10), and Short Stretch Bandage group (n=10). All treatments were stopped on the eighth day. All measurements taken preoperatively were repeated postoperative 1st, 3rd, 5th, 8th, 14th, 28th days, 6th week, and 3rd month. The functional level was measured in the sixth week and third month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study included a three parallel group of blinded evaluators. These cases were followed up with a planned follow-up program between preoperative and postoperative three months.
| Arm | Type | Receives |
|---|---|---|
| Elastic bandaging | Experimental | Other: Elastic bandagingPatients who have undergone TKA for primary knee OA |
| Short stretch bandaging | Experimental | Other: Short stretch bandagingPatients who have undergone TKA for primary knee OA |
| Kinesio taping | Experimental | Other: Kinesio tapingPatients who have undergone TKA for primary knee OA |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 years or older patients who had undergone unilateral TKA surgery for primary knee osteoarthritis, rheumatoid arthritis, and posttraumatic arthritis.
Key exclusion criteria (3 listed)
- Body mass index greater than or equal to 35 kg/m2,
- Having a neurological or peripheral vascular disease,
- Having a contraindication condition for compression application (e.g., acute cellulitis, arterial insufficiency, unstable heart disease, acute deep vein thrombosis), and kinesio taping application (e.g., presence of active infectious, lymphedema and/ or cancer history)
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 |
|---|---|---|
| Elastic bandagingThe bandages were wrapped circularly along the extremity from the toes to the groin, drawing an "8" at the ankle with a 50% overlap rate, starting with 80% tension and decreasing the pressure proximally. | Other | Elastic bandaging |
| Short stretch bandagingShort tension bandage application was started on postoperative day 1 following the removal of the drains. According to the width of the extremity, using short tension bandages of 6, 8 and 10 cm width, starting from the sole of the foot, the first layer was wrapped circularly with 50% overlapping rate, 80% tension, and wrapped from the sole of the foot to the groin. | Other | Short stretch bandaging |
| Kinesio tapingKinesio taping was applied in the form of a fan by cutting into 4 longitudinal pieces using the lymphatic correction technique with 15-20% tension, starting from the periphery of the inguinal lymph nodes on the medial, anterior and lateral of the leg, following the removal of the drains from the 1st post-op day. | Other | Kinesio taping |
Primary outcome
Visual Analogue Scale
Time frame: up to sixth weeks
Pain intensity, Minumum score 0: no pain, maximum score 10: worst pain
2 secondary outcomes
Measuring Tape Measure
Time frame: up to sixth weeks
The Knee Society Clinical Scoring System
Time frame: up to sixth weeks
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 9 May 2023.
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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.
Gürsoy Coşkun, Assoc. Prof principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Elastic bandaging, Short stretch bandaging and Kinesio taping in people with Knee Osteoarthritis, 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 9 May 2023. 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?
Visual Analogue Scale (time frame: up to sixth weeks). 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 9 May 2023.