search
Back to results

Investigation of the Effect of Pilates Exercises on Patellofemoral Pain

Primary Purpose

Patellofemoral Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Exercise
Supervised Rehabilitation
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain focused on measuring Patellofemoral pain, Pilates exercises, exercise therapy,

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Supervised Rehabilitation

Pilates Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Muscle strength assessment
Quadriceps strength will be measured using the Lafayette Manual Muscle Tester (Lafayette Instrument-model 01165, USA) handheld dynamometer.
Muscle flexibility assessment
The flexibility of the hamstring muscles' length will be measured with the "Sit and Reach Test".
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.

Full Information

First Posted
March 31, 2023
Last Updated
April 12, 2023
Sponsor
Istanbul University
Collaborators
DUNİYA BAİRAMOVA
search

1. Study Identification

Unique Protocol Identification Number
NCT05811637
Brief Title
Investigation of the Effect of Pilates Exercises on Patellofemoral Pain
Official Title
Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
DUNİYA BAİRAMOVA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain
Keywords
Patellofemoral pain, Pilates exercises, exercise therapy,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized and trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pilates Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates Exercise
Intervention Description
The program will be applied with the Pilates exercises every week. All patients were evaluated before and after the treatment (6 weeks).
Intervention Type
Other
Intervention Name(s)
Supervised Rehabilitation
Intervention Description
The program will be applied with the progression of the supervised rehabilitation in the 4th week
Primary Outcome Measure Information:
Title
Functional assessment
Description
Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.
Time Frame
6 weeks
Title
Pain assessment
Description
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").
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Muscle strength assessment
Description
Quadriceps strength will be measured using the Lafayette Manual Muscle Tester (Lafayette Instrument-model 01165, USA) handheld dynamometer.
Time Frame
6 weeks
Title
Muscle flexibility assessment
Description
The flexibility of the hamstring muscles' length will be measured with the "Sit and Reach Test".
Time Frame
6 weeks
Title
Quality of life assessment
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derya Çelik, Prof
Phone
+90 532 794 01 69
Email
ptderya@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Duniya Bairamova, Msc
Phone
05541175646
Email
duniya.bayramova@hotmail.com
Facility Information:
Facility Name
Istanbul University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of the Effect of Pilates Exercises on Patellofemoral Pain

We'll reach out to this number within 24 hrs