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Clinical Trials/NCT05811637
NCT05811637
Completed
Not Applicable

Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

Istanbul University1 site in 1 country34 target enrollmentApril 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Pain
Sponsor
Istanbul University
Enrollment
34
Locations
1
Primary Endpoint
Functional assessment
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aimed to investigate the effectiveness of Pilates exercises in Patellofemoral pain patients compared to hip and knee combined exercises in improving pain, muscle strength, flexibility, function and quality of life in short term.

Detailed Description

Patellofemoral pain is a common condition characterized by pain in anterior knee, around the kneecap. It is known that exercise is beneficial in rehabilitation in general. Exercise programs applied to patients with PFP should include hip and knee-targeted combined exercises. Nowadays, Pilates is used as an effective rehabilitation tool for individuals with musculoskeletal problems, especially in reducing pain and improving function. Therefore, we believe that Pilates exercises can be effective in PFP Considering that PFP is a chronic condition and exercise therapy is one of the main strategies in the treatment. Pilates may be preferred as one of the alternative treatment method. This randomized controlled study was designed to compare the effects of two different treatment protocols, Group-I (Supervised Rehabilitation) and Group-II (Pilates Exercises). Patients who applied to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Sports Medicine outpatient clinic and were diagnosed with PFP by a specialist physician based on the patient histories, physical examinations, and diagnostic imaging. The estimated desired sample size was at least 14 participants per group. We anticipated a dropout rate of 20%. Therefore, 34 participants were required for each group (Supervised Rehabilitation n=17, Pilates Exercises n=17) of both sexes, ages ranging from 18-45 years. A computer generated randomization list was used to divide the patients into two groups (https://www.randomizer.org/). An 'Informed Consent Form' was obtained from patients by explaining the purpose of the study, the duration of the study, the treatments to be applied, and possible side effects.

Registry
clinicaltrials.gov
Start Date
April 15, 2023
End Date
November 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Derya Celik

Prof.

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • Having characteristic signs of PFP (retropatellar or peripatellar pain)
  • Presence of at least 3 points of retropatellar or peripatellar pain on the Numbered Pain Rating Scale (NPRS) with squatting, climbing stairs, prolonged sitting, or functional activity that burdens the PFP
  • Presence of any of the criteria such as tenderness, small effusion in the patellar facet palpation

Exclusion Criteria

  • Patellofemoral dislocation, subluxation, intra-articular knee pathology
  • Previous lower extremity surgery, and knee-related trauma
  • A history of hip pathology or neurological disorders
  • Knee trauma in the last 1 month

Outcomes

Primary Outcomes

Functional assessment

Time Frame: 6 weeks

Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.

Pain assessment

Time Frame: 6 weeks

The numerical NPRS is used to measure and monitor the severity of pain. The patients will be asked to rate the severity of the current pain level between 0 and 10 (0 being "no pain" and 10 being the "worst imaginable pain").

Secondary Outcomes

  • Muscle flexibility assessment(6 weeks)
  • Muscle strength assessment(6 weeks)
  • Quality of life assessment(6 weeks)

Study Sites (1)

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