Pilates-based Core Strengthening on Patellofemoral Pain Syndrome (Pilates)

Incorporation of Pilates-based Core Strengthening Exercises Into the Rehabilitation Protocol for Adolescents With Patellofemoral Pain Syndrome: a Randomized Clinical Trial

Patellofemoral pain syndrome (PFPS) is one of the most common musculoskeletal pain conditions that tend to become a chronic problem. PFPS is common among young adolescents, particularly in physically active individuals aged 12 to 17 years old with more prevalence among females, as it affects females 1.5 - 3 times when compared to males.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Other: Pilates exercises; Other: Traditional physical therapy program

Detailed Description

Adolescents with PFPS usually complain of retro-patellar pain (behind the kneecap) or peripatellar pain (around the kneecap) and crepitation in the knee joint, and also there is discomfort while sitting with a flexed knee for a long time. Symptoms are usually exacerbated by activities that increase the load on patellofemoral joints such as weight-bearing activities, squatting, walking up or downstairs, and running.

PFPS takes place whenever the muscles around the knee fail to keep the kneecap properly aligned, leading to abnormal lateral tracking of the patella.Overuse such as running and jumping sports, the trauma of kneecaps such as fracture, dislocation, or knee surgery may also predispose to PFPS.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al-Kharj, Riyadh, Saudi Arabia
      • Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pain felt anterior to knee joint.
• Pain felt retro-patellar.
• Pain felt during rest and increased with activities like prolonged sitting, squatting, running, and stair climbing.
• Insidious onset lasting for more than 6 weeks.
• Without any traumatic incidence.
• Not participating in a physical therapy program for the past three months.

Exclusion Criteria:

• If they had a meniscal tear.
• Cruciate/collateral ligaments involvement.
• Knee osteoarthritis.
• Rheumatoid arthritis.
• A history of knee or hip surgery.
• Patellar dislocation/subluxation.
• Traction apophysitis encompassing the patellofemoral complex.
• Any pathology in the patellar tendon.
• Spinal referred pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; Patients in the study group received Pilates exercises (25 minutes/ session). There are different types of equipment to be used in Pilates exercises to achieve different purposes; mat, Pilates band or elastic bands, and Pilate's ball were used.	Other: Pilates exercises; Side kick internal/ external rotation with Pilate's band; Other Names: Pilates band
Experimental: control group; Participants in control group received the traditional physical therapy program program (60 minutes/session, three sessions /week for three months).	Other: Traditional physical therapy program; strength, flexibility; Other Names: strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	assessed by using a visual analog scale, 10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation	at baseline
Pain assessment	assessed by using a visual analog scale,10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation	after 12 weeks
Muscle strength assessment	assessed using a calibrated handheld dynamometer	at baseline
Muscle strength assessment	assessed using a calibrated handheld dynamometer	after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	evaluated using the Arabic version of the Anterior Knee pain Questionnaire, The score ranges from 0 to 100, with 0 indicating complete functional limitation and 100 indicating no pain and no functional limitation.	at baseline
Functional status	evaluated using the Arabic version of the Anterior Knee pain Questionnaire, The score ranges from 0 to 100, with 0 indicating complete functional limitation and 100 indicating no pain and no functional limitation.	after 12 weeks
health-related quality of life	assessed by using the self-report Pediatric Quality of Life Inventory, it includes 23 items distributed among 4 domains [physical (8 items), emotional (5 items), social (5 items), and school functions (3 items)]. Each item is rated on a 5- points scale (0 means never, and 4 means almost always). Items are transformed linearly to 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).	at baseline
health-related quality of life	assessed by using the self-report Pediatric Quality of Life Inventory, it includes 23 items distributed among 4 domains [physical (8 items), emotional (5 items), social (5 items), and school functions (3 items)]. Each item is rated on a 5- points scale (0 means never, and 4 means almost always). Items are transformed linearly to 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).	after 12 weeks

Collaborators and Investigators

• Sponsor: Qassim University
• Collaborators: Cairo University; Prince Sattam Bin Abdulaziz University

Publications and helpful links

General Publications

• Park SK, Stefanyshyn DJ. Greater Q angle may not be a risk factor of patellofemoral pain syndrome. Clin Biomech (Bristol, Avon). 2011 May;26(4):392-6. doi: 10.1016/j.clinbiomech.2010.11.015. Epub 2010 Dec 21.
• Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157.
• Van Der Heijden RA, Lankhorst NE, Van Linschoten R, Bierma-Zeinstra SM, Van Middelkoop M. Exercise for treating patellofemoral pain syndrome: an abridged version of Cochrane systematic review. Eur J Phys Rehabil Med. 2016 Feb;52(1):110-33. Epub 2015 Jul 9.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: functional status; Pilates exercises; patellofemoral pain syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: RHPT/20/0049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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