- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06625086
Effect of Web-Based Exercise on Patellofemoral Pain
Investigation of the Effectiveness of a Web-Based Remote Exercise Program in Patients With Patellofemoral Pain Syndrome
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Patellofemoral pain syndrome (PFPS) is one of the most common and challenging knee disorders to treat. It refers to pain around the patella and surrounding structures. PFPS was first described in 1928 and is most frequently observed in active women, athletes, and military personnel. It accounts for a significant portion of musculoskeletal complaints and knee problems, and the actual prevalence may be higher as not all cases are diagnosed. The diagnosis of patellofemoral syndrome largely relies on a detailed and accurate history and physical examination. Symptoms can be unilateral or bilateral and often include pain associated with activities such as kneeling, stair climbing, squatting, and running. PFPS is characterized by an imbalance among the static and dynamic structures of the lower extremity, muscle imbalance, overactivity, overload, and trauma. Patients with PFPS exhibit abnormalities in mechanical and dynamic control of the lower extremity.
Most treatment approaches for PFPS are conservative, with surgical interventions being rare. Treatment programs typically involve a multimodal physiotherapy approach, including functional patient education, lower extremity strengthening, flexibility, proprioception, endurance, and stretching exercises.
Upon reviewing the existing literature, no studies were found that investigated the use of a web-based remote exercise program among patients with PFPS.
Therefore, the aim of this study is to investigate the effectiveness of a web-based remote, timed exercise program on pain, functional capacity, and kinesiophobia in individuals with patellofemoral pain syndrome. The evaluation will include the Visual Analog Scale (VAS) for pain assessment, the Tampa Scale for Kinesiophobia, the Kujala questionnaire for patellofemoral function, and the Timed Up and Go (TUG) test for functional mobility.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beykoz
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Istanbul, Beykoz, Turkey, 34810
- Istanbul Medipol University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Self-Guided Exercise Group
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.
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Exercises will be provided to individuals in the Self-Guided Exercise group through a brochure.
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Experimental: Supervised Exercise Group
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.
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Exercises will be administered to individuals with PFPS under the supervision of a physiotherapist.
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Experimental: Web-Based Exercise Group
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. |
The exercises will be administered to participants through a web-based application.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: From enrollment to the end of treatment at 6 weeks
|
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.
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From enrollment to the end of treatment at 6 weeks
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Kujala Patellofemoral Scoring
Time Frame: From enrollment to the end of treatment at 6 weeks
|
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.
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From enrollment to the end of treatment at 6 weeks
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Time up and go test
Time Frame: From enrollment to the end of treatment at 6 weeks
|
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.
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From enrollment to the end of treatment at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale for Kinesiophobia
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The Tampa Scale for Kinesiophobia, which has been validated for reliability in Turkish, will be used to assess kinesiophobia.
The scale consists of 17 questions that inquire about avoidance of movement due to previous injury history or pain.
The lowest score is 17, and the highest score is 68, with a score of 37 or above indicating a high level of kinesiophobia.
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From enrollment to the end of treatment at 6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-6172
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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