NCT05120583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

November 3, 2021

Last Update Submit

November 13, 2021

Conditions

Keywords

patellofemoral pain syndromePilates exercisesfunctional status

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Functional status

    at baseline

  • Functional status

    after 12 weeks

  • health-related quality of life

    at baseline

  • health-related quality of life

    after 12 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

control group

EXPERIMENTAL

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

Interventions

Side kick internal/ external rotation with Pilate's band

Also known as: Pilates band
study group

strength, flexibility

Also known as: strengthening exercises
control group

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Al Kharj, Riyadh Region, Saudi Arabia

Location

Related Publications (3)

  • Park SK, Stefanyshyn DJ. Greater Q angle may not be a risk factor of patellofemoral pain syndrome. Clin Biomech (Bristol). 2011 May;26(4):392-6. doi: 10.1016/j.clinbiomech.2010.11.015. Epub 2010 Dec 21.

    PMID: 21177007BACKGROUND
  • 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.

    PMID: 24884455BACKGROUND
  • 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.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Alshimaa Azab, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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.

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 15, 2021

Study Start

November 1, 2020

Primary Completion

August 20, 2021

Study Completion

October 30, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations