Knee OsteoarthritisNCT03076177
The Effectiveness of Kinesio Taping Method for Knee Osteoarthritis.
A study testing Taping application in people with Knee Osteoarthritis, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
Purpose of our study is to evaluate effectiveness of Kinesio Taping method for knee osteoarthritis. Using simple concealed randomization procedure to form two groups (kinesio taping and control-nonspecific taping) of 100 knee osteoarthritis patients in each. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Taping application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteLithuania
- Study dates
- Oct 2014to 1 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed (and radiologically verified) I-III stage knee osteoarthritis, has no contraindications (exclusion criteria) to participate in research, are willing to follow studies protocol and gives informed approval to participate in this research in written form.
Who cannot join
- Rheumatoid arthritis or other systemic rheumatoid disease (LE, sclerodermia,.. etc)
- Fragile, very sensitive skin or it's lesions in areas where tapes are to be applied
- Inability to do functional tests according study protocol due to very impaired knee function or severe comorbidities.
- Diagnosed or suspected cancer in areas where tapes to be applied
- < than 6 months after intra-articular injections in knee joint
- Constant usage of analgesic medicament due to comorbidities
Show all 10Show fewer
- Pregnancy
- History of Kinesio Taping method applications in the past
- Need for orthotics
- Unwillingness not to use local ointments in knee region during participation in study period (i.e. 2 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Kinesio Taping Method for Knee Osteoarthritis. Randomized Double Blinded Clinical Trial.
Purpose of our study is to evaluate effectiveness of Kinesio Taping method for knee osteoarthritis. Using simple concealed randomization procedure to form two groups (kinesio taping and control-nonspecific taping) of 100 knee osteoarthritis patients in each. 1 month all patients (depending on the group they will be allocated to) will receive either kinesio taping applications or non-specific taping: 4 applications per subject. Three times: before taping, after a month with tapes, and after 1 month without tapes evaluation of knee function, mobility, quality of life will be evaluated, including clinical examination of knee joint, measurements of knee flexion and extension by goniometer, circumference of leg over the knee, in ½ of thigh and in ½ of calf (to evaluate edema); pain will be evaluated by questionnaire, patella tendon algometry; force of calf flexors and extensors will be evaluated using Lovett manual muscle testing scale, goniometry for knee flexion/extension; for mobility, knee function, life quality evaluations - 10 Meter Walk , Five Times Sit to Stand Tests will be performed, Knee injury and Osteoarthritis Outcome Score (KOOS) and Medical Outcomes Study Short Form 36 2 version (SF-36 2v) questionnaires will be used. Also data about the need of analgesic medicament will be collected from subjects.
Read the detailed description
After subject inclusion into research, two groups (study (kinesio taping) group and control-non specific taping) of 100 patients in each will be formed by the procedure of concealed randomization (person not connected with study by the help of random number generator will make allocation of subjects to the groups).
All subjects will receive taping (kinesio or non specific) for one month (tapes will be applied once a week, 4 times per person, held on skin for 6 days with one day break - without tape). Subjects will be allowed to use their conventional analgesic medicaments 'per os' or parenterally if needed. Control and Kinesio taping applications will be done by certified kinesio taping practitioner (CKTP) or other team member trained by CKTP (researcher 'B'). Other research team member (researcher 'A') will do evaluations of chosen criteria (pain, knee function, mobility etc.), he will not be informed to which group (kinesio taping or placebo) subject was allocated, the same researcher (researcher 'A') will do repeated evaluations for the same subject after first and second months of participation in study.
Taping applications:
Control. For non specific taping Kinesio Tape tex Gold finger print (FP) will be used, however tapes will be applied without using specific application manner of kinesio taping method. I.e. - tapes will be applied in subject lying position with knee fully extended using 0% of available tension 10 cm above and 10cm below superior and inferior poles of patella (approx 5x25cm) and on medial and lateral sides of knee joint (small pieces of tape approx. 5x5cm)
Kinesio taping. Kinesio Tape tex Gold FP will be used . Subjects will get two Y strips applied in lymphatic correction manner using paper off tension (tapes will be applied in fully flexed knee position); than two I strips will be applied for patella tendon and lateral and medial collateral ligaments using 75-100% of tension: over patella tendon - in fully flexed knee position, 100% of tension; over ligaments - in 20-30 degrees of knee flexion,75% of tension ; ends -with no tension, - seeking to increase stimulation of mechanoreceptors over the area, improve proprioception and reduce pain.
All subjects, before starting the research, will be informed in written as well as in spoken form about the research, it's type, goals, possible inconveniences (possible skin irritation, hair picking etc.). Every subject will have right to stop their participation in research at any time.
- Conditions
- Knee Osteoarthritis
- Being tested
- Taping application
- Keywords
- knee osteoarthritis, kinesio taping, knee function, pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taping applicationOther
Also called Kinesio taping/non specific taping
Kinesio taping application will be applied for experimental group; non specific taping application for control
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping group | Experimental | Participants receiving kinesio taping application Receives: Other: Taping application |
| Non specific taping | Sham comparator | Participants receiving non specific taping application Receives: Other: Taping application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain intensity from baseline at 4 weeks
Numeric Pain Rating Scale (an 11-point scale from 0-10. "0" = no pain, "10" = the most intense pain imaginable)
Measured: 4 weeks
Secondary outcomes (21)
Change in knee pain intensity from baseline at 8 weeks
Numeric Pain Rating Scale (an 11-point scale from 0-10. "0" = no pain, "10" = the most intense pain imaginable)
Measured: 8 weeks
Change in patella tendon pain threshold from baseline at 4 weeks
measured with algometer (kgf)
Measured: 4 weeks
Change in patella tendon pain threshold from baseline at 8 weeks
measured with algometer (kgf)
Measured: 8 weeks
Change in knee function at 4 weeks from baseline
measured by KOOS which consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: after 4weeks
Change in knee function at 8 weeks from baseline
measured by KOOS which consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: after 8 weeks
Change in gait speed from baseline at 4 weeks
10 Meter Walk test (m/s)
Measured: 4 weeks
Change in gait speed from baseline at 8 weeks
10 Meter Walk test (m/s)
Measured: 8 weeks
Change in time needed for five times sit to stand test from baseline at 4 weeks
Five Times Sit to Stand Tests (s)
Measured: 4 weeks
Change in time needed for five times sit to stand test from baseline at 8 weeks
Five Times Sit to Stand Tests (s)
Measured: 8 weeks
Change in knee flexion from baseline at 4 weeks
measured active knee flexion in standardized position with goniometer (degrees)
Measured: 4 weeks
Change in knee flexion from baseline at 8 weeks
measured active knee flexion in standardized position with goniometer (degrees)
Measured: 8 weeks
Change in knee extension from baseline at 4 weeks
measured active knee extension in standardized position with goniometer (degrees)
Measured: 4 weeks
Change in knee extension from baseline at 8 weeks
measured active knee extension in standardized position with goniometer (degrees)
Measured: 8 weeks
Change in leg circumference (thigh, knee, calf) from baseline at 4 weeks
leg circumference with tape measured in standardized points of leg (thigh, knee, calf region) (cm)
Measured: 4 weeks
Change in leg circumference (thigh, knee, calf) from baseline at 8 weeks
leg circumference with tape measured in standardized points of leg (thigh, knee, calf region) (cm)
Measured: 8 weeks
Change in patient-reported outcome measure of health-related quality of life from baseline at 4 weeks
Medical Outcomes Study Short Form 36 2 version (SF-36v2) will be used. Measure is divided into 8 subscales and 2 composite domains
The 8 subscales are:
- Physical Functioning
- Role Limitations due to Physical Problems
- General Health Perceptions
- Vitality
- Social Functioning
- Role Limitations due to Emotional Problems
- General Mental Health
- Health Transition Respondents are asked to answer items referring to the past 4 weeks Recommended scoring system for the SF-36 is a weighted Likert system for each item Items within subscales are totaled to provide a summed score for each subscale or dimension.
Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale.
Measured: 4 weeks
Change in patient-reported outcome measure of health-related quality of life from baseline at 8 weeks
Medical Outcomes Study Short Form 36 2 version (SF-36v2) will be used. Measure is divided into 8 subscales and 2 composite domains
The 8 subscales are:
- Physical Functioning
- Role Limitations due to Physical Problems
- General Health Perceptions
- Vitality
- Social Functioning
- Role Limitations due to Emotional Problems
- General Mental Health
- Health Transition Respondents are asked to answer items referring to the past 4 weeks Recommended scoring system for the SF-36 is a weighted Likert system for each item Items within subscales are totaled to provide a summed score for each subscale or dimension.
Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale.
Measured: 8 weeks
Objective tolerance of taping (kinesio, non-specific) method
inspection of skin for any signs of redness, rash, etc., evaluated once every week
Measured: first 4 weeks of participation
Subjective tolerance of taping (kinesio, non-specific) method
questionnaire for subjective evaluation of method from participants (side effects, inconveniences, skin problems, comments, opinion on pain relief and improvement on mobility) evaluated once every week
Measured: first 4 weeks of participation
Change in need of analgesic medicament from baseline at 4 weeks
questionnaire about the need of analgesic medicament (type of drug, dose, frequency of use recorded)
Measured: 4 weeks
Change in need of analgesic medicament from baseline at 8 weeks
questionnaire about the need of analgesic medicament (type of drug, dose, frequency of use recorded)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startOct 2014
- Primary completionJul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- International Kinesio Taping association
- Responsible party
- Principal investigator, Venta Donec, Lithuanian University of Health Sciences
- Investigators
- Raimondas Kubilius, PhD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076177
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2018
- First submitted
- 12 Sep 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Donec V, Kubilius R. The effectiveness of Kinesio Taping(R) for pain management in knee osteoarthritis: a randomized, double-blind, controlled clinical trial. Ther Adv Musculoskelet Dis. 2019 Aug 29;11:1759720X19869135. doi: 10.1177/1759720X19869135. eCollection 2019.
PubMed 31497072
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Kinesio Taping Method for Knee Osteoarthritis. Randomized Double Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT03076177
- Acronym / sponsor ID
- 1
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, kinesio taping, knee function, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- International Kinesio Taping association
- Study start
- Oct 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 10 Mar 2017 (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.
Purpose of our study is to evaluate effectiveness of Kinesio Taping method for knee osteoarthritis. Using simple concealed randomization procedure to form two groups (kinesio taping and control-nonspecific taping) of 100 knee osteoarthritis patients in each. 1 month all patients (depending on the group they will be allocated to) will receive either kinesio taping applications or non-specific taping: 4 applications per subject. Three times: before taping, after a month with tapes, and after 1 month without tapes evaluation of knee function, mobility, quality of life will be evaluated, including clinical examination of knee joint, measurements of knee flexion and extension by goniometer, circumference of leg over the knee, in ½ of thigh and in ½ of calf (to evaluate edema); pain will be evaluated by questionnaire, patella tendon algometry; force of calf flexors and extensors will be evaluated using Lovett manual muscle testing scale, goniometry for knee flexion/extension; for mobility, knee function, life quality evaluations - 10 Meter Walk , Five Times Sit to Stand Tests will be performed, Knee injury and Osteoarthritis Outcome Score (KOOS) and Medical Outcomes Study Short Form 36 2 version (SF-36 2v) questionnaires will be used. Also data about the need of analgesic medicament will be collected from subjects.
Detailed description
After subject inclusion into research, two groups (study (kinesio taping) group and control-non specific taping) of 100 patients in each will be formed by the procedure of concealed randomization (person not connected with study by the help of random number generator will make allocation of subjects to the groups).
All subjects will receive taping (kinesio or non specific) for one month (tapes will be applied once a week, 4 times per person, held on skin for 6 days with one day break - without tape). Subjects will be allowed to use their conventional analgesic medicaments 'per os' or parenterally if needed. Control and Kinesio taping applications will be done by certified kinesio taping practitioner (CKTP) or other team member trained by CKTP (researcher 'B'). Other research team member (researcher 'A') will do evaluations of chosen criteria (pain, knee function, mobility etc.), he will not be informed to which group (kinesio taping or placebo) subject was allocated, the same researcher (researcher 'A') will do repeated evaluations for the same subject after first and second months of participation in study.
Taping applications:
Control. For non specific taping Kinesio Tape tex Gold finger print (FP) will be used, however tapes will be applied without using specific application manner of kinesio taping method. I.e. - tapes will be applied in subject lying position with knee fully extended using 0% of available tension 10 cm above and 10cm below superior and inferior poles of patella (approx 5x25cm) and on medial and lateral sides of knee joint (small pieces of tape approx. 5x5cm)
Kinesio taping. Kinesio Tape tex Gold FP will be used . Subjects will get two Y strips applied in lymphatic correction manner using paper off tension (tapes will be applied in fully flexed knee position); than two I strips will be applied for patella tendon and lateral and medial collateral ligaments using 75-100% of tension: over patella tendon - in fully flexed knee position, 100% of tension; over ligaments - in 20-30 degrees of knee flexion,75% of tension ; ends -with no tension, - seeking to increase stimulation of mechanoreceptors over the area, improve proprioception and reduce pain.
All subjects, before starting the research, will be informed in written as well as in spoken form about the research, it's type, goals, possible inconveniences (possible skin irritation, hair picking etc.). Every subject will have right to stop their participation in research at any time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping group | Experimental | Other: Taping applicationParticipants receiving kinesio taping application |
| Non specific taping | Sham comparator | Other: Taping applicationParticipants receiving non specific taping application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed (and radiologically verified) I-III stage knee osteoarthritis, has no contraindications (exclusion criteria) to participate in research, are willing to follow studies protocol and gives informed approval to participate in this research in written form.
Key exclusion criteria (10 listed)
- Rheumatoid arthritis or other systemic rheumatoid disease (LE, sclerodermia,.. etc)
- Fragile, very sensitive skin or it's lesions in areas where tapes are to be applied
- Inability to do functional tests according study protocol due to very impaired knee function or severe comorbidities.
- Diagnosed or suspected cancer in areas where tapes to be applied
- < than 6 months after intra-articular injections in knee joint
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 |
|---|---|---|
| Taping applicationAlso: Kinesio taping/non specific tapingKinesio taping application will be applied for experimental group; non specific taping application for control | Other | Kinesio taping group, Non specific taping |
Primary outcome
Change in knee pain intensity from baseline at 4 weeks
Time frame: 4 weeks
Numeric Pain Rating Scale (an 11-point scale from 0-10. "0" = no pain, "10" = the most intense pain imaginable)
21 secondary outcomes
Change in knee pain intensity from baseline at 8 weeks
Time frame: 8 weeks
Change in patella tendon pain threshold from baseline at 4 weeks
Time frame: 4 weeks
Change in patella tendon pain threshold from baseline at 8 weeks
Time frame: 8 weeks
Change in knee function at 4 weeks from baseline
Time frame: after 4weeks
Change in knee function at 8 weeks from baseline
Time frame: after 8 weeks
Change in gait speed from baseline at 4 weeks
Time frame: 4 weeks
Change in gait speed from baseline at 8 weeks
Time frame: 8 weeks
Change in time needed for five times sit to stand test from baseline at 4 weeks
Time frame: 4 weeks
Change in time needed for five times sit to stand test from baseline at 8 weeks
Time frame: 8 weeks
Change in knee flexion from baseline at 4 weeks
Time frame: 4 weeks
Change in knee flexion from baseline at 8 weeks
Time frame: 8 weeks
Change in knee extension from baseline at 4 weeks
Time frame: 4 weeks
Change in knee extension from baseline at 8 weeks
Time frame: 8 weeks
Change in leg circumference (thigh, knee, calf) from baseline at 4 weeks
Time frame: 4 weeks
Change in leg circumference (thigh, knee, calf) from baseline at 8 weeks
Time frame: 8 weeks
Change in patient-reported outcome measure of health-related quality of life from baseline at 4 weeks
Time frame: 4 weeks
Change in patient-reported outcome measure of health-related quality of life from baseline at 8 weeks
Time frame: 8 weeks
Objective tolerance of taping (kinesio, non-specific) method
Time frame: first 4 weeks of participation
Subjective tolerance of taping (kinesio, non-specific) method
Time frame: first 4 weeks of participation
Change in need of analgesic medicament from baseline at 4 weeks
Time frame: 4 weeks
Change in need of analgesic medicament from baseline at 8 weeks
Time frame: 8 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 19 Dec 2018.
- Derived from this study: PubMed 31497072Donec V, Kubilius R. The effectiveness of Kinesio Taping(R) for pain management in knee osteoarthritis: a randomized, double-blind, controlled clinical trial. Ther Adv Musculoskelet Dis. 2019 Aug 29;11:1759720X19869135. doi: 10.1177/1759720X19869135. eCollection 2019.
- 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.
Raimondas Kubilius, PhD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taping application in people with Knee Osteoarthritis, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 10 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 19 Dec 2018. 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 Lithuania. 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?
Change in knee pain intensity from baseline at 4 weeks (time frame: 4 weeks). 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 NCT03076177, which also lists 1 linked publication.
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 19 Dec 2018.