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Kinesio Tape in the Treatment of Medial Plica Syndrome

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ClinicalTrials.gov Identifier: NCT04085497
Recruitment Status : Active, not recruiting
First Posted : September 11, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
TOMRIS DUYMAZ, Istanbul Bilgi University

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).

Condition or disease Intervention/treatment Phase
Medial Plica Syndrome Other: Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Investigator)
Masking Description: Single
Primary Purpose: Treatment
Official Title: Efficacy of Kinesio Tape in the Treatment of Medial Plica Syndrome - A Prospective Study
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : May 10, 2019
Estimated Study Completion Date : October 1, 2019

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.
Other: Treatment
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.
Other: Treatment
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 Measures :
  1. Pain threshold [ Time Frame: 1 minute ]
    Algometer is a tool that measures pressure pain threshold and pain tolerance in quantitative sensory tests


Secondary Outcome Measures :
  1. Pain severity: score [ Time Frame: 1 minutes ]
    Participants were told how to do it and were asked to give a score between 0-100

  2. 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'.

  3. 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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085497


Locations
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Turkey
Istanbul Bilgi University
Istanbul, Turkey, 34440
Sponsors and Collaborators
Istanbul Bilgi University
Investigators
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Principal Investigator: Tomri̇s Duymaz Istanbul Bilgi University
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Responsible Party: TOMRIS DUYMAZ, Principal Investigator, Istanbul Bilgi University
ClinicalTrials.gov Identifier: NCT04085497    
Other Study ID Numbers: MPS
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TOMRIS DUYMAZ, Istanbul Bilgi University:
Medial Plica Syndrome
Kinesio Tape
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes