NCT05995210

Brief Summary

The aim of the study is to compare the efficacy of kinesio taping treatment and knee orthosis treatment in Patellofemoral Pain Syndrome (PFAS). 54 patients were included in the study and the patients were divided into 3 groups as kinesio taping group (KTG) (n=18), orthotics group (OG) (n=18) and control group (CG) (n=18). A progressive exercise program was applied to all groups and patients were treated 2 days a week for 6 weeks.While kinesio taping was applied to KTG in each session, knee orthosis was given to OG and they were asked to use it for 6 weeks. Visual Analogue Scale (VAS), Kujala Score, Knee injury and Osteoarthritis Outcome Score (KOOS) and isokinetic strength test (IST) were used in the evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

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

December 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

July 3, 2023

Last Update Submit

September 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in baseline Kujala scores of patients treated at week 6

    It is a score that evaluates symptoms and function in patients with patellofemoral pain syndrome. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.

    6 weeks

Secondary Outcomes (3)

  • Change in baseline Visual Analogue Scale of patients treated at week 6

    6 weeks

  • Change in baseline Knee Injury and Osteoarthritis Outcome Score of patients treated at week 6

    6 weeks

  • Change in baseline isokinetic strength test of patients treated at week 6

    6 weeks

Study Arms (3)

Kinesio taping group

EXPERIMENTAL

In addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks.

Procedure: Kinesio tapingProcedure: Control

Orthosis group

EXPERIMENTAL

In addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks.

Procedure: OrthosisProcedure: Control

Control group

ACTIVE COMPARATOR

A standard exercise program was applied for 6 weeks.

Procedure: Control

Interventions

A corrective kinesio taping was applied to the patellofemoral joint for the knee. In addition, exercise therapy was taken.

Kinesio taping group
OrthosisPROCEDURE

They were asked to use a knee orthosis for a minimum of 6 hours a day. They also received exercise therapy.

Orthosis group
ControlPROCEDURE

An exercise program focused on the knee and hip muscles was given two days a week.

Control groupKinesio taping groupOrthosis group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18-45
  • Patients with a body mass index (BMI) less than 29.9
  • Anterior knee pain defined as 3 points on the 10 cm Visual Analogue Scale when performing at least two activities of sitting for a long time, climbing/descending stairs, squatting, running and jumping

You may not qualify if:

  • Patients with knee osteoarthritis
  • History of surgery involving the lower extremity
  • Patellar or quadriceps tendinopathy
  • Injury to the meniscus or knee ligaments
  • Patients showing an allergic response to kinesio tape
  • Patients previously treated with PFAS
  • Existing hip pathologies
  • History of patellar subluxation or dislocation
  • Patients with neurological disorders
  • Patients who did not fill out the voluntary consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Yunus Özdemir, MSc

    Medipol University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective randomized controlled single-blind
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

July 3, 2023

First Posted

August 16, 2023

Study Start

December 9, 2021

Primary Completion

May 5, 2023

Study Completion

June 16, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations