Kinesio Tape in the Treatment of Medial Plica Syndrome
Primary Purpose
Medial Plica Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Medial Plica Syndrome focused on measuring Medial Plica Syndrome, Kinesio Tape
Eligibility Criteria
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
Sites / Locations
- Istanbul Bilgi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Group 2
Arm Description
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.
Outcomes
Primary Outcome Measures
Pain threshold
Algometer is a tool that measures pressure pain threshold and pain tolerance in quantitative sensory tests
Secondary Outcome Measures
Pain severity: score
Participants were told how to do it and were asked to give a score between 0-100
Disability scale
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'.
Nottingham Health Profile
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.
Full Information
NCT ID
NCT04085497
First Posted
September 9, 2019
Last Updated
September 11, 2019
Sponsor
Istanbul Bilgi University
1. Study Identification
Unique Protocol Identification Number
NCT04085497
Brief Title
Kinesio Tape in the Treatment of Medial Plica Syndrome
Official Title
Efficacy of Kinesio Tape in the Treatment of Medial Plica Syndrome - A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
October 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to investigate the efficacy of kinesio tape (KT) on pain severity, pain threshold, lower extremity functional muscle strength and dynamic balance, functional status, and quality of life in patients with Medial Plica Syndrome (MPS).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Plica Syndrome
Keywords
Medial Plica Syndrome, Kinesio Tape
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were divided into two groups, each comprising 40 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.
Masking
Investigator
Masking Description
Single
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
The exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups.
Intervention Type
Other
Intervention Name(s)
Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain threshold
Description
Algometer is a tool that measures pressure pain threshold and pain tolerance in quantitative sensory tests
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Pain severity: score
Description
Participants were told how to do it and were asked to give a score between 0-100
Time Frame
1 minutes
Title
Disability scale
Description
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'.
Time Frame
5 minutes
Title
Nottingham Health Profile
Description
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.
Time Frame
8 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomri̇s Duymaz
Organizational Affiliation
Istanbul Bilgi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Bilgi University
City
Istanbul
ZIP/Postal Code
34440
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Kinesio Tape in the Treatment of Medial Plica Syndrome
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