NCT07531550

Brief Summary

Study Purpose: The purpose of this study is to investigate the effect of adding core muscle strengthening exercises to a hip- and knee-focused exercise program on pain intensity, dynamic knee valgus (DKV), and functional outcomes in female patients with patellofemoral pain syndrome (PFPS). Research Question: Does adding core muscle strengthening exercises to a hip- and knee-focused exercise program have an effect on pain intensity, dynamic knee valgus (DKV), and functional outcomes in female patients with PFPS?

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable pain

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 29, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2026

Last Updated

April 15, 2026

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

March 29, 2026

Last Update Submit

April 12, 2026

Conditions

Keywords

Dynamic knee valgus (DKV)

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity During Motion

    Pain intensity during movement will be assessed using the Visual Analog Scale (VAS). The VAS is a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

    Baseline (pre-intervention) and at 6 weeks (post-intervention)

  • Knee Function

    Knee function will be assessed using the Knee Outcome Survey (KOS). The KOS score ranges from 0 to 100, where higher scores indicate better knee function.

    Baseline (pre-intervention) and at 6 weeks (post-intervention)

  • Pain Intensity at Rest

    Pain intensity at rest will be assessed using the Visual Analog Scale (VAS). The VAS is a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

    Baseline (pre-intervention) and at 6 weeks (post-intervention)

  • Dynamic Knee Valgus (DKV)

    Dynamic knee valgus will be assessed by measuring the knee valgus angle in degrees during functional tasks. Higher values indicate greater valgus deviation and poorer knee alignment.

    Baseline (pre-intervention) and at 6 weeks (post-intervention)

Study Arms (2)

control group hip and knee focused exercises program

ACTIVE COMPARATOR

Open kinetic chain exercises including side-lying hip abduction, hip external rotation (clamshell), prone hip extension, short arc quadriceps, and straight leg raises 1. Closed kinetic chain exercises including mini wall squats and terminal knee extensions 2. Flexibility exercises targeting tight lower extremity soft tissues, including a seated hamstring stretch, standing quadriceps stretch, and standing wall stretch for the gastrocnemius

Behavioral: hip and knee-focused exercise program

Study group hip and knee focused exercises program in addition to core muscle training exercises

EXPERIMENTAL

participants who will received the same exercise program as control group, in addition to core muscle training exercises, including the front plank, side plank, and dead bug exercises

Behavioral: Core Muscle Stability Exercise Program

Interventions

Open kinetic chain exercises including side-lying hip abduction, hip external rotation (clamshell), prone hip extension, short arc quadriceps, and straight leg raises (Khayambashi et al., 2012) ( Dolak et al., 2011). 1. Closed kinetic chain exercises including mini wall squats and terminal knee extensions (Hott et al., 2020). 2. Flexibility exercises targeting tight lower extremity soft tissues, including a seated hamstring stretch, standing quadriceps stretch, and standing wall stretch for the gastrocnemius

control group hip and knee focused exercises program

core muscle training exercises, including the front plank, side plank, and dead bug exercises

Study group hip and knee focused exercises program in addition to core muscle training exercises

Eligibility Criteria

Age19 Weeks - 35 Weeks
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale participants diagnosed and referred with PFPS (retropatellar knee pain lasting more than 6 weeks
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Thirty-six female participants diagnosed and referred with patellofemoral pain syndrome (PFPS) (retropatellar knee pain lasting more than 6 weeks).
  • Age range between 19-35 years.
  • Body Mass Index (BMI) up to 25 kg/m².

You may not qualify if:

  • History of previous surgeries of the lower limb.
  • Clinical evidence of knee joint complex disorders, including meniscus lesions, 3-patellar tendinopathy, chondral lesions, or knee osteoarthritis.
  • Presence of pronated foot.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University - Faculty of Physical Therapy

Giza, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Papaverine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Radwa M Hussien, Pt, PhD

    Cairo University - Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Radwa M Hussien, PT, PhD

CONTACT

Dina S Abdallah, PT, PhD, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double-blinded study in which both participants and physiotherapists are unaware of group allocation due to the similarity of intervention protocols.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a parallel assignment interventional model in which participants are allocated into two groups. The intervention group receives a core muscle stability exercise program, while the control group receives conventional physiotherapy. Both groups are treated concurrently throughout the study period, and outcomes are assessed before and after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 15, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 4, 2026

Study Completion (Estimated)

December 4, 2026

Last Updated

April 15, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) from this study. All collected data will remain confidential and will not be made publicly available in order to protect participant privacy and comply with ethical regulations. Access Criteria: Not applicable, as individual participant data will not be shared.

Locations