NCT02854774

Brief Summary

This is a randomized controlled trial of knee muscle versus hip muscle strengthening for Patellofemoral Pain Syndrome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

June 7, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

August 30, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2016

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

June 7, 2016

Last Update Submit

April 30, 2020

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pain reduction measured using a visual analog scale (VAS) for knee pain

    Compared to baseline

    4 weeks and 6 months

Secondary Outcomes (3)

  • Brain function measured using fMRI

    4 weeks

  • Muscle activation assessed with electromyographic (EMG) recordings

    4 weeks

  • Knee kinematics assessed with 3-dimensional motion capture

    4 weeks

Study Arms (2)

Knee muscle activation/strengthening

ACTIVE COMPARATOR

4 weeks of exercises focused on activation and strengthening of knee extensor muscles.

Behavioral: Muscle activation exercises

Hip muscle activation/strengthening

ACTIVE COMPARATOR

4 weeks of exercises focused on activation and strengthening of hip extensor muscles.

Behavioral: Muscle activation exercises

Interventions

Muscle activation exercisesBEHAVIORAL

Activation of either muscles activating the knee or hip.

Hip muscle activation/strengtheningKnee muscle activation/strengthening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain located specifically around the patellofemoral articulation (vague or localized).
  • Readily reproducible pain (3 out of 10 on a visual analog scale) with at least 2 of the following functional activities commonly associated with PFP: stair ascent or descent, squatting, kneeling, prolonged sitting, or isometric quadriceps contraction.
  • Reports of pain greater than 3 months duration.

You may not qualify if:

  • Previous history of knee surgery.
  • History of traumatic patellar dislocation.
  • Neurological involvement that would influence gait.
  • Contraindications to MR imaging: implanted electronic devices (i.e. pacemaker), or metallic implants (i.e. aneurysm clips, fixation screws).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90049, United States

Location

Related Publications (2)

  • Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.

    PMID: 22027216RESULT

  • Khayambashi K, Fallah A, Movahedi A, Bagwell J, Powers C. Posterolateral hip muscle strengthening versus quadriceps strengthening for patellofemoral pain: a comparative control trial. Arch Phys Med Rehabil. 2014 May;95(5):900-7. doi: 10.1016/j.apmr.2013.12.022. Epub 2014 Jan 16.

    PMID: 24440362RESULT

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 7, 2016

First Posted

August 3, 2016

Study Start

August 30, 2016

Primary Completion

November 11, 2016

Study Completion

November 11, 2016

Last Updated

May 5, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)