NCT04085497

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

September 9, 2019

Last Update Submit

September 11, 2019

Conditions

Keywords

Medial Plica SyndromeKinesio Tape

Outcome Measures

Primary Outcomes (1)

  • Pain threshold

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

    1 minute

Secondary Outcomes (3)

  • Pain severity: score

    1 minutes

  • Disability scale

    5 minutes

  • Nottingham Health Profile

    8 minutes

Study Arms (2)

Treatment

EXPERIMENTAL

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

Group 2

PLACEBO COMPARATOR

The exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups.

Other: Treatment

Interventions

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.

Group 2Treatment

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between the ages of 20 and 55
  • Diagnosed as medial plica syndrome by MPP test and MRI imaging
  • Did not develop cartilage damage

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Bilgi University

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Tomri̇s Duymaz

    Istanbul Bilgi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

January 2, 2019

Primary Completion

May 10, 2019

Study Completion

October 1, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations