NCT06017778

Brief Summary

Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform to functional activities, such as walking, running, climbing stairs, and sitting for prolonged periods. PFPS is often associated with pain and discomfort in the front of the knee, which can limit an individual's range of motion and cause difficulty with weight-bearing activities. The pain may also be exacerbated by activities that involve bending the knee, such as squatting or kneeling. Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance, and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may help reduce pain and improve functional abilities in individuals with PFPS However, the evidence for the effectiveness of WBV as an intervention for PFPS is still limited, and more research is needed to fully understand its potential benefits and limitations. It is important to note that WBV may not be suitable for all individuals with PFPS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 19, 2023

Last Update Submit

August 28, 2023

Conditions

Keywords

Patellofemoral pain syndromevibrationPlanter/Dorsi ratiopain

Outcome Measures

Primary Outcomes (3)

  • Dorsi/planter torque ratio

    dorsi/planter torque ratio will be measured through the Biodex System 4-Pro Isokinetic Strength Dynamometer for assessment of muscle torque

    one month

  • functional activities

    Kujala Anterior Knee Pain Scale, which includes questions related to functional activities.

    one month

  • Pain intensity

    10 cm Visual Analogue Scale (VAS) was used to assess pain intensity during activity in patients with patellofemoral pain (PFP). The scale ranged from 0, indicating "no pain," to 100, representing the "worst pain imaginable.

    one month

Study Arms (2)

whole body viberation group

EXPERIMENTAL
Device: whole body vibrationOther: traditional exercise group

control group

ACTIVE COMPARATOR
Other: traditional exercise group

Interventions

patients will receive WBV training in addition to traditional training will be performed on a tri-planar (mostly vertical, Z axis) oscillating vibration platform (Power PlateR pro5™; Power Plate North America, Inc., Northbrook, IL,USA) for 20-30 minutes per session. WBV training will be supervised and performed in a clinic three days a week with at least one day between each session for four weeks (total of 12 sessions).

whole body viberation group

10 minutes warm-up (lower extremity stretching exercises), 20-30 minutes period of strength exercises with three sets of 10-15 repetitions (isometric quadriceps setting, knee extensions, double-legged wall squat), and 5 minutes cool-down (lower extremity stretching exercises). Lower extremity stretching exercises consisted of quadriceps, hamstring, gastrocnemius and iliotibial band stretching with 3 repetitions for 30 s each muscle.

control groupwhole body viberation group

Eligibility Criteria

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

You may qualify if:

  • Age: Adults aged 18 -35 years
  • Symptoms: Pain in the anterior or retro patellar knee region during activities such as running, jumping, squatting, or prolonged sitting
  • Duration: Pain lasting at least 6 weeks

You may not qualify if:

  • Presence of other knee conditions: Individuals with PFPS who also have other knee conditions such as ligament or meniscal injuries, osteoarthritis, or patellar tendinopathy may be excluded.
  • History of knee surgery: Patients who have undergone any knee surgery may be excluded as this may affect the outcomes of the study.
  • Systemic conditions: Patients with systemic conditions that may affect the musculoskeletal system such as rheumatoid arthritis or lupus may be excluded.
  • Pregnancy: Pregnant women with PFPS may be excluded as pregnancy may affect the outcomes of the study.
  • Inability to comply with study requirements: Patients who are unable to comply with the study requirements such as attending follow-up appointments or completing questionnaires may be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy , cairo university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 19, 2023

First Posted

August 30, 2023

Study Start

August 30, 2023

Primary Completion

October 30, 2023

Study Completion

November 30, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
6 months after publication
Access Criteria
study protocol

Locations