Pilates-based Core Strengthening on Patellofemoral Pain Syndrome

Sponsor

Qassim University (Other)

Overall Status

Completed

CT.gov ID

NCT05120583

Collaborator

Cairo University (Other), Prince Sattam Bin Abdulaziz University (Other)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Pain Syndrome	Other: Pilates exercises Other: Traditional physical therapy program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Aug 20, 2021

Actual Study Completion Date :

Oct 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Functional status [at baseline]
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 [after 12 weeks]
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 [at baseline]
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 [after 12 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University	Al-Kharj	Riyadh	Saudi Arabia

Sponsors and Collaborators

Qassim University
Cairo University
Prince Sattam Bin Abdulaziz University

Investigators

Study Director: Alshimaa Azab, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Maged Basha, Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt., Qassim University

ClinicalTrials.gov Identifier:

NCT05120583

Other Study ID Numbers:

RHPT/20/0049

First Posted:

Nov 15, 2021

Last Update Posted:

Nov 22, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maged Basha, Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt., Qassim University

patellofemoral pain syndrome

Pilates exercises

functional status

Additional relevant MeSH terms:

Patellofemoral Pain Syndrome

Syndrome

Somatoform Disorders

Study Results

No Results Posted as of Nov 22, 2021