NCT06758050

Brief Summary

the goal of this interventional study is to Investigate the effect of core strengthening exercises on pain, strength, function, and balance in patients with PFPS.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 26, 2024

Last Update Submit

December 26, 2024

Conditions

Keywords

core strengthening exercises, hip and knee-focused exercises, patellofemoral pain syndrome

Outcome Measures

Primary Outcomes (2)

  • Pain

    by Visual analog scale

    6 weeks

  • knee function

    by Anterior knee pain scale ( AKPS) ( Kujala )

    6 weeks

Secondary Outcomes (2)

  • Muscle strength

    6 weeks

  • Balance

    6 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Group B (study group) (core strengthening exercises added to evidence-based approaches group) The core muscle strength training program The core muscle strength training program will last for 6 weeks and comprise of two training sessions per week, with a total of 12 sessions for the study group. During the main part of the training, the "big 3" exercises as described by McGill will be conducted. These include the curl-up, side bridge, and quadruped position.

Other: Core strengthening exercisesOther: Traditional treatment

Control group

ACTIVE COMPARATOR

Group A (control group) (evidence-based approaches group): The participants in the control group will receive only a hip and knee- focused exercise program. 1. Hip-focused exercise: Based on previous studies, hip-focused exercises will consist of side- lying hip abduction, hip external rotation (clamshell), and prone hip extension. 2. Knee-focused exercise The knee-focused exercise regime will be based on previous studies and consist of supine straight leg raises, supine terminal knee extensions (from 10° flexion to full extension), and a mini squat (45° flexion) with the back supported against the wall (to reduce stabilizing requirements from the hip muscles).

Other: Traditional treatment

Interventions

By core strengthening exercise, could be improved pain, balance, and function in patients with patellofemoral pain syndrome. In that case, this will not only improve their postural stability and neuromuscular control, but we believe it will improve their overall functional, performance, and quality of life. Currently, limited evidence exists about the effectiveness of core strengthening exercises on pain, function and dynamic balance in patellofemoral pain syndrome. By addressing core strengthening exercise, physical therapists can advise new treatment methods for patellofemoral pain syndrome (Chevidikunnan et al., 2016)

Study group

hip and knee-focused exercises

Control groupStudy group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both genders with an age range of 18- 35 years old.
  • Gradual development of pain in the front of the knee lasting more than 12 weeks.
  • Patients with body mass index 18- 25 kg m2.
  • Pain is aggravated by at least 2 of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting.
  • Positive patellar grinding test.
  • Insidious onset of symptoms, unrelated to a traumatic damage.

You may not qualify if:

  • Traumatic patellar subluxation or dislocation.
  • A history of any of the following conditions: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.
  • Any lower limb bony or congenital deformities.
  • Previous knee and hip joint surgeries.
  • Osteoarthritis in the ankle, knee, or hip joints.
  • Conditions that affect muscle strength such as diabetes mellitus or rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • rana ibrahim ahmed, Bachelor Physical Therapy-MUST

    Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR
  • Nasr Awad Abd Elkader, Assistant Professor

    Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo University

    STUDY CHAIR
  • Abdelgalil Allam Abdelgalil, Lecturer of Physical Therapy

    Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo University

    STUDY DIRECTOR
  • Mohammed Safwat Hamza, Associate Professor

    Faculty of Medicine Misr University for Science and Technology

    STUDY DIRECTOR

Central Study Contacts

Rana Ibrahim Ahmed, Bachelor Physical Therapy-MUST

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rana Ibrahim Ahmed Mahmoud

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

August 4, 2024

Primary Completion

January 15, 2025

Study Completion

January 30, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Locations