Investigation of the Effect of Pilates Exercises on Patellofemoral Pain

Sponsor
Istanbul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05811637
Collaborator
DUNİYA BAİRAMOVA (Other)
36
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2
5
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pilates Exercise
  • Other: Supervised Rehabilitation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized and trialRandomized and trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Actual Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Functional assessment [6 weeks]

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

  2. Pain assessment [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 Outcome Measures

  1. Muscle strength assessment [6 weeks]

    Quadriceps strength will be measured using the Lafayette Manual Muscle Tester (Lafayette Instrument-model 01165, USA) handheld dynamometer.

  2. Muscle flexibility assessment [6 weeks]

    The flexibility of the hamstring muscles' length will be measured with the "Sit and Reach Test".

  3. Quality of life assessment [6 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University
  • DUNİYA BAİRAMOVA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Derya Celik, Prof., Istanbul University
ClinicalTrials.gov Identifier:
NCT05811637
Other Study ID Numbers:
  • D2023
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Derya Celik, Prof., Istanbul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2023