NCT05597670

Brief Summary

Purpose: to investigate the effect of proximal stability on PF OA. Methods: Thirty patients with PF OA will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional physical therapy treatment, but group (B) will receive additional proximal stability exercise. All patients will be evaluated for muscular recruitment strategies (onset and duration) of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti measured by quantitative Electromyography during stair descent. pre and post-treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

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

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

October 25, 2022

Last Update Submit

June 1, 2024

Conditions

Outcome Measures

Primary Outcomes (10)

  • The change of EMG onset of multifidus

    investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG duration of multifidus

    investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG duration of vastus medialis obliqus

    investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG onset of vastus medialis obliqus

    investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG onset of vastus lateralis

    investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG duration of vastus lateralis

    investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG duration of gluteus medius

    investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG onset of gluteus medius

    investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG onset of transversus abdominus

    investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes

    baseline and six weeks

  • The change of EMG duration of transversus abdominus

    investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes

    baseline and six weeks

Secondary Outcomes (1)

  • kinesiophobia

    baseline and six weeks

Study Arms (2)

group A

OTHER

Patients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degree knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators

Other: traditional knee rehabilitation program

group B

EXPERIMENTAL

Patients in this group will receive the same program as group (A) plus proximal stabilization exercise

Other: traditional knee rehabilitation programOther: proximal stabilization

Interventions

Patients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degree knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators

group Agroup B

the principles of proximal stability will be explained to patients before initiation of treatment and patients will be asked to comply with these principles during exercise. These principles include learning how to activate transversus abdominus by abdominal bracing without allowing pelvis tilting and ensure neutral spine and diaphragmatic breathing during exercise.

group B

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

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 .
  • The professional athletes; people who exercise more than two hours a day or every other day, will be 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional physical therapy treatment, but group (B) will receive additional proximal stability exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

November 29, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations