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

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Pilates exercises
Traditional physical therapy program
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring patellofemoral pain syndrome, Pilates exercises, functional status

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

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.

Participants in control group received the traditional physical therapy program program (60 minutes/session, three sessions /week for three months).

Outcomes

Primary Outcome Measures

Pain assessment
assessed by using a visual analog scale, 10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Pain assessment
assessed by using a visual analog scale,10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Muscle strength assessment
assessed using a calibrated handheld dynamometer
Muscle strength assessment
assessed using a calibrated handheld dynamometer

Secondary Outcome Measures

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.
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.
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).
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).

Full Information

First Posted
November 3, 2021
Last Updated
November 13, 2021
Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05120583
Brief Title
Pilates-based Core Strengthening on Patellofemoral Pain Syndrome
Acronym
Pilates
Official Title
Incorporation of Pilates-based Core Strengthening Exercises Into the Rehabilitation Protocol for Adolescents With Patellofemoral Pain Syndrome: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
patellofemoral pain syndrome, Pilates exercises, functional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Experimental
Arm Description
Participants in control group received the traditional physical therapy program program (60 minutes/session, three sessions /week for three months).
Intervention Type
Other
Intervention Name(s)
Pilates exercises
Other Intervention Name(s)
Pilates band
Intervention Description
Side kick internal/ external rotation with Pilate's band
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy program
Other Intervention Name(s)
strengthening exercises
Intervention Description
strength, flexibility
Primary Outcome Measure Information:
Title
Pain assessment
Description
assessed by using a visual analog scale, 10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Time Frame
at baseline
Title
Pain assessment
Description
assessed by using a visual analog scale,10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation
Time Frame
after 12 weeks
Title
Muscle strength assessment
Description
assessed using a calibrated handheld dynamometer
Time Frame
at baseline
Title
Muscle strength assessment
Description
assessed using a calibrated handheld dynamometer
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Functional status
Description
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.
Time Frame
at baseline
Title
Functional status
Description
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.
Time Frame
after 12 weeks
Title
health-related quality of life
Description
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).
Time Frame
at baseline
Title
health-related quality of life
Description
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).
Time Frame
after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
City
Al-Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
21177007
Citation
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.
Results Reference
background
PubMed Identifier
24884455
Citation
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.
Results Reference
background
PubMed Identifier
26158920
Citation
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.
Results Reference
result

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Pilates-based Core Strengthening on Patellofemoral Pain Syndrome

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