Investigation of the Effect of Pilates Exercises on Patellofemoral Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patellofemoral Pain
• Intervention / Treatment: Other: Supervised Rehabilitation; Other: Pilates Exercise

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. Thirty-six patients (Supervised Rehabilitation n=18, Pilates Exercises n=18) 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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Derya Çelik, Prof; Phone Number: +90 532 794 01 69; Email: ptderya@hotmail.com
• Study Contact Backup: Name: Duniya Bairamova, Msc; Phone Number: 05541175646; Email: duniya.bayramova@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supervised Rehabilitation; The supervised rehabilitation focused mainly on strengthening the hip-knee muscles and flexibility exercises for the gastrocnemius and hamstring muscles. Hip and knee targeted strengthening and stretching exercises will be applied for 6 weeks, two sessions a week 12 sessions of all exercises, 3 sets, and 10-15 repetitions of each set.	Other: Supervised Rehabilitation; The program will be applied with the progression of the supervised rehabilitation in the 4th week
Active Comparator: Pilates Exercise; The principles of Pilates exercises will be taught to the patients in the first session, and the evaluation will be made. The exercises, including basic training exercises in the first week, will be performed for 6 weeks, each session lasting 45 minutes, two days a week, each exercise for 8-12 repetitions. The Pilates exercises, consisting of gradually increasing strengthening will be applied under the supervision of a physiotherapist.	Other: Pilates Exercise; The program will be applied with the Pilates exercises every week. All patients were evaluated before and after the treatment (6 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional assessment	Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.	6 weeks
Pain assessment	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").	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength assessment	Quadriceps strength will be measured using the Lafayette Manual Muscle Tester (Lafayette Instrument-model 01165, USA) handheld dynamometer.	6 weeks
Muscle flexibility assessment	The flexibility of the hamstring muscles' length will be measured with the "Sit and Reach Test".	6 weeks
Quality of life assessment	The short form SF-36v2 will be used to assess the quality of life. The scale, designed to assess the quality of life, covers physical, social, and psychological conditions.	6 weeks

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: DUNİYA BAİRAMOVA

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Patellofemoral pain, Pilates exercises, exercise therapy,
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: D2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No