NCT04589702

Brief Summary

Objective: To compare the temporal muscle activation between females with PF OA and normal controls during stair ascent. Methods: An observational comparative study was conducted with thirty-one females with PF OA and 11 healthy ones. The onset times of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles were measured by quantitative Electromyography during stair ascent task. hypothesis: Investigators hypothesized that there won't be a significant difference between females with PF OA and their matched healthy group regarding the onset times of vastus medialis obliqus (VMO), vastus lateralis (VL), gluteus medius (GM), multifidus, and transversus abdominus (TrA), during stair ascent task.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

October 5, 2020

Last Update Submit

October 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The EMG onset of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles

    investigators collected the EMG activity of VMO, VL, GM, multifidus, and TrA using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    from admission to discharge, up to two weeks

Study Arms (2)

females with isolated patellofemoral arthritis

those with anterior knee pain

healthy females

those without anterior knee pain

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients were recruited from the Outpatient Clinic of Kasr Al-Ainy Hospital and the Faculty of Physical Therapy, Cairo University as well. However, control subjects were recruited via advertising in the local community.

You may qualify if:

  • Anterior- or retro-patellar knee pain aggravated by at least two activities that load the PFJ (eg; stair ambulation, squatting and/or rising from sitting) .
  • Pain during these activities presented on most days during the past month and their pain severity was ≥ 4 on an 11 point numerical pain scale during aggravating activities .,
  • A grade less than (2) from postero-anterior views on the Kellgren - Lawrence (KL) grading scale.
  • \. no history of knee pathology or pain with any of the provocative activities which were mentioned above.

You may not qualify if:

  • \. concomitant pain from tibiofemoral joint or other knee structures .
  • current or previous pain in the hip, lumbar spine or foot that had lasted longer than 3 months and/or required intervention.
  • a history of lower extremity, pelvis or spine fractures; spine, hip, knee or foot surgeries; hip or patellar subluxation/ dislocation.
  • injury to any of knee ligaments or meniscus.
  • systemic diseases (e.g. rheumatoid arthritis), neurological conditions or fibromyalgia . 5.The professional athletes; people who exercise more than two hours a day or every other day, were also excluded .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Chondromalacia Patellae

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aladdin A. balbaa, professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 19, 2020

Study Start

March 1, 2019

Primary Completion

October 10, 2019

Study Completion

September 30, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations