NCT05665452

Brief Summary

Patellofemoral pain syndrome is a common source of anterior knee pain. The causes of PFPS may be multifactorial such as biomechanical disorders, muscle weakness which affect the dynamic stability of lower limb and alter patellar tracking in trochlear groove. Moreover, the syndrome associated with muscular tightness of iliotibial band, gastrocnemius, soleus, hamstring and quadriceps. Strengthening and stretching exercises are effective in improving patient's symptoms. However, they do not sufficient in correction of kinematic changes associated with PFPS. Patellar mobilization is effective in improving patient'symptoms in cases with PFPS. However, studies that conducted patellar mobilization were either low quality studies or no study combined patellar mobilization with hip and knee exercises. Therefore, APTA guidelines recommended for conducting high quality study to investigate the effect of adding patellar mobilization to exercise therapy to support the definite recommendation delivered to therapists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

First Submitted

Initial submission to the registry

October 26, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

October 26, 2022

Last Update Submit

August 19, 2024

Conditions

Keywords

patellofemoral pain syndromestrengthstretchmobilizationreleasedeep friction messageretinacula

Outcome Measures

Primary Outcomes (2)

  • Changes in pain that felt during ascending, descending, squatting and prolonged sitting

    Pain during ascending, descending, squatting and prolonged sitting will be assessed using visual analogue scale, it is a horizontal line from 0 to 10, where 0 no pain and 10 maximum pain.

    It will be assessed one week before and after treatment

  • Changes in functional disability

    Functional disability will be assessed using Kujala questionnaire.The scale ranges from 0 to 100 score where 100 represents no functional limitation.

    It will be assessed one week before and after treatment

Secondary Outcomes (8)

  • Changes in hip abductors strength

    It will be assessed one week before and after treatment

  • Changes in hip external rotators strength

    It will be assessed one week before and after treatment

  • changes in quadriceps strength

    It will be assessed one week before and after treatment

  • changes in functional performance

    It will be assessed one week before and after treatment

  • changes in hamstring flexibility

    It will be assessed one week before and after treatment

  • +3 more secondary outcomes

Study Arms (2)

Group (1)

ACTIVE COMPARATOR

patients will receive stretch and strength exercises

Procedure: Patellar mobilization, retinacula release, deep friction message, stretch and strength

Group (2)

EXPERIMENTAL

patients will receive stretch, strength, patellar mobilization, retinacula release and deep friction message

Procedure: Patellar mobilization, retinacula release, deep friction message, stretch and strength

Interventions

All exercises will be performed for 30 to 45 minutes per session, 3 times per week for 4 weeks (12 sessions). Group (1): stretch exercises are performed for calf, hamstring, iliotibial band and quadriceps. strength exercises consist from open kinetic chain (hip abductors, hip external rotators and quadriceps) and closed kinetic chain exercises (mini wall squat exercise, forward step up exercise, lateral step up exercise and terminal knee extension exercise). Group (2): stretch exercises are performed for calf, hamstring, iliotibial band and quadriceps. strength exercises consist from open kinetic chain (hip abductors, hip external rotators and quadriceps) and closed kinetic chain exercises (mini wall squat exercise, forward step up exercise, lateral step up exercise and terminal knee extension exercise). manual therapy consists from iliotibial band release, deep friction message for lateral retinacula and medial patella mobilization.

Group (1)Group (2)

Eligibility Criteria

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

You may qualify if:

  • Age ranging between 18 and 35 years
  • Tenderness of medial and lateral borders of patella
  • Retropatellar pain
  • Duration of symptoms of patellofemoral pain syndrome is greater than 4 weeks
  • Positive patellar compression test
  • Pain intensity is more than 3 at visual analogue scale
  • Had a history of insidious onset
  • Had anterior knee pain during 2 or more of provocative activities that include stair ascent or descent, kneeling, prolonged sitting, or squatting

You may not qualify if:

  • Previous patellar realignment surgery or patellar fracture
  • Had a history of traumatic patellar dislocation
  • Had a history of previous knee surgery
  • Had any form of inflammatory arthritis that include osteoarthritis or rheumatoid arthritis
  • Had a history of knee menisci, ligaments, bursae, or synovial plica syndrome dysfunction
  • Taking corticosteroids or nonsteroidal anti-inflammatory medication
  • Inability to attend treatment program to the end of sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

Related Publications (1)

  • Abdo N, Youssef EF, Ibrahim MM. Efficacy of adding manual therapy to hip and knee exercises in patients with patellofemoral pain syndrome: a double-blinded randomized controlled clinical trial. Sci Rep. 2025 Sep 23;15(1):32655. doi: 10.1038/s41598-025-17453-9.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Nadia A Mohamed, Msc

    Assistant lecturer at orthopedic department of faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at orthopedic department of faculty of physical therapy

Study Record Dates

First Submitted

October 26, 2022

First Posted

December 27, 2022

Study Start

January 15, 2023

Primary Completion

December 11, 2023

Study Completion

March 18, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations