- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04085497
Kinesio Tape in the Treatment of Medial Plica Syndrome
Efficacy of Kinesio Tape in the Treatment of Medial Plica Syndrome - A Prospective Study
Study Overview
Detailed Description
This randomized prospective controlled trial was designed, conducted and reported in accordance with the standards of the CONSORT (Consolidated Standards of Reporting Trials) statement. The approval of the Istanbul Bilgi University Clinical Investigations Ethics Committee was obtained, and the enrolled subjects signed a free and informed consent form.
Trial design KT was applied once a week, 6 times in total. Exercises were performed for all patients for 5 weeks 5 days a week, 3 sets 15 repetitions each day. The exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups.
Intervention KT application: KT application includes 2 stages. The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee. The second step is directed directly on the medial plica to benefit from its analgesic effect. For the first step, an I-band is measured from the top of the patella to the tuberositas tibia. I-band is 6 cm wide and 5 mm thick. This I-band is cut into Y-band. First, the part of the band above the patella is pasted with 10% tension. Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension. The tails of the band are combined together on the tuberositas and completed. For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared. The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape.
Participants The study was included 80 patients with diagnosed as MPS in the Orthopedics and Traumatology outpatient clinic of Bağcılar Training and Research Hospital. MPS was diagnosed by MRI imaging in patients with pain and MPP test in the patella anteromedial. The patients were divided into two groups, each comprising 50 patients. KT and exercise were given to the patients in the first group, and only exercise was given to the patients in the second group. The inclusion criteria included patients between the ages of 20 and 55 who were diagnosed as MPS by MPP test and MRI imaging and did not develop cartilage damage. Patients with meniscal tear, chondral injury or instability of the knee were excluded.
Outcome measurements Measurements were performed twice before and after the treatment for all patients. Pain threshold with digital algometer, pain severity with visual analog scale (VAS), disability level with Lysholm Knee Scoring Scale, functional strength and dynamic balance of lower extremity with stairs up and down test, quality of life with Nottingham Health Profile (NHP) were evaluated before and after treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34440
- Istanbul Bilgi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients between the ages of 20 and 55
- Diagnosed as medial plica syndrome by MPP test and MRI imaging
- Did not develop cartilage damage
Exclusion Criteria:
- Patients with meniscal tear, chondral injury or instability of the knee
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
KT was applied once a week, 6 times in total.
Exercises were performed for all patients for 5 weeks 5 days a week, 3 sets 15 repetitions each day.
|
KT application: KT application includes 2 stages.
The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee.
The second step is directed directly on the medial plica to benefit from its analgesic effect.
For the first step, an I-band is measured from the top of the patella to the tuberositas tibia.
I-band is 6 cm wide and 5 mm thick.
This I-band is cut into Y-band.
First, the part of the band above the patella is pasted with 10% tension.
Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension.
The tails of the band are combined together on the tuberositas and completed.
For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared.
The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape.
|
|
Placebo Comparator: Group 2
The exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups.
|
KT application: KT application includes 2 stages.
The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee.
The second step is directed directly on the medial plica to benefit from its analgesic effect.
For the first step, an I-band is measured from the top of the patella to the tuberositas tibia.
I-band is 6 cm wide and 5 mm thick.
This I-band is cut into Y-band.
First, the part of the band above the patella is pasted with 10% tension.
Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension.
The tails of the band are combined together on the tuberositas and completed.
For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared.
The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain threshold
Time Frame: 1 minute
|
Algometer is a tool that measures pressure pain threshold and pain tolerance in quantitative sensory tests
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity: score
Time Frame: 1 minutes
|
Participants were told how to do it and were asked to give a score between 0-100
|
1 minutes
|
|
Disability scale
Time Frame: 5 minutes
|
The Lysholm Knee Scoring scale is a scale used in all knee injuries.
8 parameters (limp, using cane or crutches, locking sensation in the knee, giving way sensation from the knee, pain, swelling, climbing stairs, squatting) are evaluated.When calculating the score, the most appropriate option is selected in each parameter and the total score is found by adding the scores obtained from the whole parameter.
Lysholm knee score; ≥95 points are rated as 'excellent', 84-94 points as 'good', 65-83 points as 'moderate', ≤64 points as 'bad'.
|
5 minutes
|
|
Nottingham Health Profile
Time Frame: 8 minutes
|
The Nottingham Health Profile (NHP) was used to determine quality of life of the participants.
This scale consists of 38 items formed as yes-no questions that cover 6 subscales of the quality of life.
These six subscales are sleep (5 item), energy level (3 item), emotional status (9 item), social isolation (5 item), physical mobility (8 item) and pain (8 item).
Each section is scored from 0-100.
0 indicates the best health status, 100 indicates the worst health status.
|
8 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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