SurgeryNCT02747901
Comparison Between Kinesiotaping and Cold Therapy After Total Knee Arthroplasty
A study testing KINESIOTAPING and COLD THERAPY in people with Surgery, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- KINESIOTAPING and COLD THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years older above
- have a primary total knee arthroplasty
Who cannot join
- revision total knee arthroplasty
- unable to understand verbal and written instructions
- having previously orthopaedic or neurological disorder that causes gait disturbance and having surgery within six months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylül University
İ̇zmi̇r, 35340
Bayram Unver, Prof, PT., +02324124928, bayram.unver@deu.edu.tr
About this study
Official title: Comparison Between Kinesiotaping and Cold Therapy on Muscle Strength and Functional Performance Outcomes After Total Knee Arthroplasty: a Randomized Controlled Trial
The investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37).
Read the detailed description
Total knee arthroplasty (TKA) has been established as a valuable procedure patients with end-stage osteoarthritis and the rates of elective TKA are increasing steadily each year. Ninety percent of patients reported reduced pain, improved functional ability, and greater health related quality of life after TKA. Kinesiotaping (KT), a type of elastic tape that is being increasingly used for the management of pain and oedema after surgery
- . Cold therapy (CT) can also help relieve pain and swelling during early postoperative period
- . These two application may have impact on functional performance outcomes in patients with TKA. The number of studies that include KT in the rehabilitation process is increasing, but there isn't any study that compare KT application and CT after TKA.
The aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period.
Methods One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37). KT group are going to receive KT for lymphatic correction and rectus femoris facilitation technique. CT group are going to receive CT immediately after operation and following postoperative days. After surgery, all patients will receive standard post-operative treatment including continuous passive motion, active-assistive and active range of motion exercises, isometric and isotonic strengthening exercises, gait training and transfer training. After operation, pain intensity, active range of motion and knee function score [Hospital for Special Surgery (HSS) score] Functional activities are going to evaluate using the Iowa Level of Assistance Scale, and walking speed was evaluated using the Iowa Ambulation Velocity Scale. Isometric muscle strength measure of quadriceps femoris and hamstring muscles assessed by Hand-Held Dynamometer. All measurements evaluated at the discharge. One way ANOVA is going to be used in statistical analysis.
- Conditions
- Surgery
- Being tested
- KINESIOTAPING, COLD THERAPY
- Keywords
- KINESIOTAPING, COLD THERAPY, FUNCTIONAL PERFORMANCE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINESIOTAPINGOther
Kinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique.
COLD THERAPYOther
Cold therapy group received cold packs immediately after operation and following postoperative days
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping Group | Experimental | Kinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique. Receives: Other: KINESIOTAPING |
| Cold Therapy Group | Active comparator | Cold Therapy group received cold pack immediately after operation and following postoperative days. Receives: Other: COLD THERAPY |
| Control Group | No intervention | Control group have no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum isometric muscle strength of Quadriceps and hamstring muscles of all the patients will be measured using Hand Held Dynamometer (Lafayette Instrument Company, Lafayette, Ind., USA).
Before the measurement, the subjects seat with the hips on the edge of the bed, knees at ninety degree of flexion, feet free and arms crossed on the chest, without a support. The subjects complete maximum knee extension during the test. When the knee extension was achieved, the participant will be asked to continue maximum isometric contraction for five seconds. Then the mean value of three consecutive maximum contraction measurements will be taken. For the maximum isometric muscle strength of hamstring muscles of all the patients will be measured using Hand Held Dynamometer. Before the measurement, subjects lay prone on the bed, knees at ninety degree of flexion. Same measurement techniques will be used.
Measured: Post-operative three months
Secondary outcomes (2)
Pain intensity of the knees will be measured by a numerical rating scale.
Subjects will be asked to verbally rate the pain in and around the knee during activity and rest on the numeric rating scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
Measured: Post-operative three months
The active knee range of motion will be measured using a full circle manual goniometer.
The active knee range of motion will measured using a full circle manual goniometer made of flexible clear plastic with arms 30 cm in length. The patient will be positioned in the prone position.
Measured: Post-operative three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionApr 2017 (estimated)
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 SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertugrul Yuksel, Dokuz Eylul University
- Investigators
- Vasfi Karatosun, Prof, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747901
- Sponsor's protocol ID
- 1886-GOA
- Status last verified
- Apr 2016
- First submitted
- 27 Mar 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data (IPD) are going to be kept.
Publications
Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13.
PubMed 24819349Adie S, Kwan A, Naylor JM, Harris IA, Mittal R. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007911. doi: 10.1002/14651858.CD007911.pub2.
PubMed 22972114
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Kinesiotaping and Cold Therapy on Muscle Strength and Functional Performance Outcomes After Total Knee Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02747901
- Acronym / sponsor ID
- 1886-GOA
- Conditions
- Surgery
- Keywords
- KINESIOTAPING, COLD THERAPY, FUNCTIONAL PERFORMANCE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- 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 investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37).
Detailed description
Total knee arthroplasty (TKA) has been established as a valuable procedure patients with end-stage osteoarthritis and the rates of elective TKA are increasing steadily each year. Ninety percent of patients reported reduced pain, improved functional ability, and greater health related quality of life after TKA. Kinesiotaping (KT), a type of elastic tape that is being increasingly used for the management of pain and oedema after surgery
- . Cold therapy (CT) can also help relieve pain and swelling during early postoperative period
- . These two application may have impact on functional performance outcomes in patients with TKA. The number of studies that include KT in the rehabilitation process is increasing, but there isn't any study that compare KT application and CT after TKA.
The aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period.
Methods One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37). KT group are going to receive KT for lymphatic correction and rectus femoris facilitation technique. CT group are going to receive CT immediately after operation and following postoperative days. After surgery, all patients will receive standard post-operative treatment including continuous passive motion, active-assistive and active range of motion exercises, isometric and isotonic strengthening exercises, gait training and transfer training. After operation, pain intensity, active range of motion and knee function score [Hospital for Special Surgery (HSS) score] Functional activities are going to evaluate using the Iowa Level of Assistance Scale, and walking speed was evaluated using the Iowa Ambulation Velocity Scale. Isometric muscle strength measure of quadriceps femoris and hamstring muscles assessed by Hand-Held Dynamometer. All measurements evaluated at the discharge. One way ANOVA is going to be used in statistical analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping Group | Experimental | Other: KINESIOTAPINGKinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique. |
| Cold Therapy Group | Active comparator | Other: COLD THERAPYCold Therapy group received cold pack immediately after operation and following postoperative days. |
| Control Group | No intervention | –Control group have no intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40 years older above
- have a primary total knee arthroplasty
Key exclusion criteria (3 listed)
- revision total knee arthroplasty
- unable to understand verbal and written instructions
- having previously orthopaedic or neurological disorder that causes gait disturbance and having surgery within six months.
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 |
|---|---|---|
| KINESIOTAPINGKinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique. | Other | Kinesiotaping Group |
| COLD THERAPYCold therapy group received cold packs immediately after operation and following postoperative days | Other | Cold Therapy Group |
Primary outcome
The maximum isometric muscle strength of Quadriceps and hamstring muscles of all the patients will be measured using Hand Held Dynamometer (Lafayette Instrument Company, Lafayette, Ind., USA).
Time frame: Post-operative three months
Before the measurement, the subjects seat with the hips on the edge of the bed, knees at ninety degree of flexion, feet free and arms crossed on the chest, without a support. The subjects complete maximum knee extension during the test. When the knee extension was achieved, the participant will be asked to continue maximum isometric contraction for five seconds. Then the mean value of three consecutive maximum contraction measurements will be taken. For the maximum isometric muscle strength of hamstring muscles of all the patients will be measured using Hand Held Dynamometer. Before the measurement, subjects lay prone on the bed, knees at ninety degree of flexion. Same measurement techniques will be used.
2 secondary outcomes
Pain intensity of the knees will be measured by a numerical rating scale.
Time frame: Post-operative three months
The active knee range of motion will be measured using a full circle manual goniometer.
Time frame: Post-operative three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Results publication: PubMed 24819349Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13.
- Results publication: PubMed 22972114Adie S, Kwan A, Naylor JM, Harris IA, Mittal R. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007911. doi: 10.1002/14651858.CD007911.pub2.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are going to be kept.
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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.
Vasfi Karatosun, Prof study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KINESIOTAPING and COLD THERAPY in people with Surgery, run by Dokuz Eylul 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 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: status not confirmed, as of the sponsor's last update on 22 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bayram Unver, Prof. (+902324123928, bayram.unver@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum isometric muscle strength of Quadriceps and hamstring muscles of all the patients will be measured using Hand Held Dynamometer (Lafayette Instrument Company, Lafayette, Ind., USA). (time frame: Post-operative three months). 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 NCT02747901, 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 22 Apr 2016.