Investigation of the Effect of Pilates Exercises on Patellofemoral Pain

Patellofemoral Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811637
• Other study ID #: D2023
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: Istanbul University
• Contact: Derya Çelik, Prof
• Phone: +90 532 794 01 69
• Email: ptderya[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain
• Patellofemoral Pain Syndrome

Intervention

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).
• Supervised Rehabilitation
The program will be applied with the progression of the supervised rehabilitation in the 4th week

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	DUNIYA BAIRAMOVA

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional assessment	Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.	6 weeks
Primary	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	Muscle strength assessment	Quadriceps strength will be measured using the Lafayette Manual Muscle Tester (Lafayette Instrument-model 01165, USA) handheld dynamometer.	6 weeks
Secondary	Muscle flexibility assessment	The flexibility of the hamstring muscles' length will be measured with the "Sit and Reach Test".	6 weeks
Secondary	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