- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076177
The Effectiveness of Kinesio Taping Method for Knee Osteoarthritis.
The Effectiveness of Kinesio Taping Method for Knee Osteoarthritis. Randomized Double Blinded Clinical Trial.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania, LT-50009
- LithuanianUHS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesio taping group
Participants receiving kinesio taping application
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Kinesio taping application will be applied for experimental group; non specific taping application for control
Other Names:
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Sham Comparator: Non specific taping
Participants receiving non specific taping application
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Kinesio taping application will be applied for experimental group; non specific taping application for control
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knee pain intensity from baseline at 4 weeks
Time Frame: 4 weeks
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Numeric Pain Rating Scale (an 11-point scale from 0-10.
"0" = no pain, "10" = the most intense pain imaginable)
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knee pain intensity from baseline at 8 weeks
Time Frame: 8 weeks
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Numeric Pain Rating Scale (an 11-point scale from 0-10.
"0" = no pain, "10" = the most intense pain imaginable)
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8 weeks
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Change in patella tendon pain threshold from baseline at 4 weeks
Time Frame: 4 weeks
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measured with algometer (kgf)
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4 weeks
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Change in patella tendon pain threshold from baseline at 8 weeks
Time Frame: 8 weeks
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measured with algometer (kgf)
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8 weeks
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Change in knee function at 4 weeks from baseline
Time Frame: after 4weeks
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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.
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after 4weeks
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Change in knee function at 8 weeks from baseline
Time Frame: after 8 weeks
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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.
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after 8 weeks
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Change in gait speed from baseline at 4 weeks
Time Frame: 4 weeks
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10 Meter Walk test (m/s)
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4 weeks
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Change in gait speed from baseline at 8 weeks
Time Frame: 8 weeks
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10 Meter Walk test (m/s)
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8 weeks
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Change in time needed for five times sit to stand test from baseline at 4 weeks
Time Frame: 4 weeks
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Five Times Sit to Stand Tests (s)
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4 weeks
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Change in time needed for five times sit to stand test from baseline at 8 weeks
Time Frame: 8 weeks
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Five Times Sit to Stand Tests (s)
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8 weeks
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Change in knee flexion from baseline at 4 weeks
Time Frame: 4 weeks
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measured active knee flexion in standardized position with goniometer (degrees)
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4 weeks
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Change in knee flexion from baseline at 8 weeks
Time Frame: 8 weeks
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measured active knee flexion in standardized position with goniometer (degrees)
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8 weeks
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Change in knee extension from baseline at 4 weeks
Time Frame: 4 weeks
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measured active knee extension in standardized position with goniometer (degrees)
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4 weeks
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Change in knee extension from baseline at 8 weeks
Time Frame: 8 weeks
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measured active knee extension in standardized position with goniometer (degrees)
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8 weeks
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Change in leg circumference (thigh, knee, calf) from baseline at 4 weeks
Time Frame: 4 weeks
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leg circumference with tape measured in standardized points of leg (thigh, knee, calf region) (cm)
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4 weeks
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Change in leg circumference (thigh, knee, calf) from baseline at 8 weeks
Time Frame: 8 weeks
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leg circumference with tape measured in standardized points of leg (thigh, knee, calf region) (cm)
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8 weeks
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Change in patient-reported outcome measure of health-related quality of life from baseline at 4 weeks
Time Frame: 4 weeks
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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:
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. |
4 weeks
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Change in patient-reported outcome measure of health-related quality of life from baseline at 8 weeks
Time Frame: 8 weeks
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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:
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. |
8 weeks
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Objective tolerance of taping (kinesio, non-specific) method
Time Frame: first 4 weeks of participation
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inspection of skin for any signs of redness, rash, etc., evaluated once every week
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first 4 weeks of participation
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Subjective tolerance of taping (kinesio, non-specific) method
Time Frame: first 4 weeks of participation
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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
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first 4 weeks of participation
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Change in need of analgesic medicament from baseline at 4 weeks
Time Frame: 4 weeks
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questionnaire about the need of analgesic medicament (type of drug, dose, frequency of use recorded)
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4 weeks
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Change in need of analgesic medicament from baseline at 8 weeks
Time Frame: 8 weeks
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questionnaire about the need of analgesic medicament (type of drug, dose, frequency of use recorded)
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8 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Raimondas Kubilius, PhD, Lithuanian University of Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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