NCT06625086

Brief Summary

Patellofemoral pain syndrome (PFPS) is a common and challenging knee condition, characterized by pain around the patella. It primarily affects active women, athletes, and military personnel. PFPS accounts for a significant portion of musculoskeletal and knee complaints, though its true prevalence may be higher due to underdiagnosis. Diagnosis is based on a detailed history and physical exam, with symptoms like pain during activities such as kneeling, stair climbing, squatting, and running. The condition is caused by muscle imbalance, overactivity, overload, and trauma, leading to mechanical and dynamic control issues in the lower extremities. Most PFPS treatments are conservative, focusing on physiotherapy approaches that include patient education, strengthening, flexibility, proprioception, and stretching exercises. Surgical interventions are rare. Current literature lacks studies on the use of web-based remote exercise programs for PFPS patients. Therefore, this study aims to evaluate the effectiveness of a web-based, timed exercise program on pain, functional capacity, and kinesiophobia in individuals with PFPS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

October 5, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

October 1, 2024

Last Update Submit

April 4, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    The Visual Analog Scale is used to measure the intensity of pain. The patient is asked to assess their pain on a line with values ranging from 0-10, where 0 means no pain, and 10 means unbearable pain. Individuals mark their pain intensity on this line according to their pain situation.

    From enrollment to the end of treatment at 6 weeks

  • Kujala Patellofemoral Scoring

    The Kujala Patellofemoral Scoring scale was developed in 1993 by Kujala and colleagues to assess knee functionality in problems related to the patellofemoral structure. It has been proven to be a valid, reliable, and sensitive scale for patients with PFPS. The scale consists of 13 questions, and the scoring system ranges from 0 to 100, from worst to best. A higher score indicates better performance.

    From enrollment to the end of treatment at 6 weeks

  • Time up and go test

    The Timed Up and Go (TUG) test is a functional assessment used to evaluate patients' mobility, balance, and walking abilities. Patients will be instructed to start from a seated position in a chair, stand up on command, walk as quickly as possible at a safe walking speed for a predetermined distance of 3 meters, turn around at the end point, and return to sit in the chair. The time from when they stand up until they sit down again will be recorded with a stopwatch. The test will be repeated three times, and the average time will be calculated.

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (1)

  • Tampa Scale for Kinesiophobia

    From enrollment to the end of treatment at 6 weeks

Study Arms (3)

Self-Guided Exercise Group

ACTIVE COMPARATOR

A brochure explaining and demonstrating the exercises to be performed in treatment will be provided to 20 patients with PFPS. Patients will be asked to follow the exercise program for 6 weeks, 3 days per week, performing each exercise twice a day with 10 repetitions for each exercise.

Other: Convensional exercises

Supervised Exercise Group

EXPERIMENTAL

Twenty patients with PFPS will perform exercises taught under the supervision of a physiotherapist for 6 weeks, 3 days per week, with each exercise performed twice a day and repeated 10 times.

Other: Supervised exercises

Web-Based Exercise Group

EXPERIMENTAL

Group 3 (Web-Based Exercise Group): Twenty patients with PFPS will participate in a web-based exercise program for 6 weeks, 3 days per week, with each exercise performed twice a day and repeated 10 times. Web-Based Remote Exercise Program: The web-based application will be created using iOS and Android operating systems. Exercises specifically designed for PFPS treatment will be included in the application through video tutorials. Descriptive text explaining each exercise will be provided below each video. Information on how well each participant adheres to the exercise program, how frequently they perform each exercise, and their current status will be recorded.

Other: Web based exercises

Interventions

Exercises will be provided to individuals in the Self-Guided Exercise group through a brochure.

Self-Guided Exercise Group

Exercises will be administered to individuals with PFPS under the supervision of a physiotherapist.

Supervised Exercise Group

The exercises will be administered to participants through a web-based application.

Web-Based Exercise Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having atraumatic pain lasting for at least 3 months,
  • Exhibiting characteristic signs of patellofemoral pain syndrome (retropatellar pain, the presence of the movie sign, and a positive patellar grind test),
  • Having one or more positive patellofemoral pain triggers, such as prolonged sitting, squatting, kneeling, descending stairs, ascending stairs, or a positive patellar grind test,
  • No knee instability and no grade 2-3 ligament or meniscus tears,
  • Voluntary participation in the study.

You may not qualify if:

  • A history of patellofemoral dislocation, subluxation, or osteoarthritis,
  • A previous history of surgery or the presence of congenital deformity,
  • The presence of neurological or rheumatological disease,
  • Speech or comprehension impairment that affects communication,
  • Having previously undergone physical therapy and rehabilitation for patellofemoral pain syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Related Publications (1)

  • Menek B, Dansuk E. Comparative Efficacy of Supervised, Web-Based, and Self-Guided Exercise Interventions in Women with Patellofemoral Pain Syndrome. Medicina (Kaunas). 2025 Apr 15;61(4):731. doi: 10.3390/medicina61040731.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

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

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

October 5, 2024

Primary Completion

February 20, 2025

Study Completion

March 15, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations