CClinicalTrials.gg
Status unknownNCT04085497Updated Sep 13, 2019

Kinesio Tape in the Treatment of Medial Plica Syndrome

An interventional study of Treatment in Medial Plica Syndrome, sponsored by Istanbul Bilgi University. Status unknown at 1 site in Turkey. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-09-13.

Sponsored by Istanbul Bilgi University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Medial Plica Syndrome

Keywords

  • Medial Plica Syndrome
  • Kinesio Tape
03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with meniscal tear, chondral injury or instability of the knee
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherTreatment

    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.

05

What researchers measure

Primary outcomes

  1. Pain threshold

    Algometer is a tool that measures pressure pain threshold and pain tolerance in quantitative sensory tests

    Time frame: 1 minute

Secondary outcomes

  1. Pain severity: score

    Participants were told how to do it and were asked to give a score between 0-100

    Time frame: 1 minutes

  2. 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'.

    Time frame: 5 minutes

  3. 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.

    Time frame: 8 minutes

06

Study locations

1 site
  • Istanbul Bilgi University
    Istanbul, 34440, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04085497
Lead sponsor
Istanbul Bilgi University
Responsible party
TOMRIS DUYMAZ (Principal Investigator, Istanbul Bilgi University) — Principal investigator
First posted
Sep 11, 2019
Start date
Jan 2, 2019
Primary completion
May 10, 2019
Completion
Oct 1, 2019 (estimated)
Last update
Sep 13, 2019

Study contacts

Tomri̇s Duymaz
principal investigator · Istanbul Bilgi University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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