NCT02914574

Brief Summary

This study primarily aims to investigate arthrogenic muscle inhibition (AMI), an underlying mechanism in patellofemoral pain (PFP), which remain to date understudied. Although, studies have revealed that AMI needs to be eliminated before improvements in muscle strength can be achieved, to date quadriceps muscle inhibition in patients with PFP remains understudied. To date the influence of AMI on functional performance and the direct link to pain in patients with PFP remain unclear. This study aims to investigate the link between AMI to pain, functional performance and how an acute treatment can affect functional performance and pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

September 22, 2016

Last Update Submit

March 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Influence of Powers strap

    The influence of the Powers strap on functional performance will be investigated by analysing hip and knee kinematics and kinetics with and without the Powers strap in participants with PFP

    1 day

Study Arms (1)

healthy control

OTHER

Healthy control group will attend one visit and functional performance, muscle strength and flexibility, quadriceps AMI, patellar position and posture will be measured. No intervention will be applied.

Other: PowersTM strap

Interventions

The powers strap aims to decrease knee varus through supporting femoral abduction and external rotation. Participants will wear the Powers strap while performing functional tasks (running, squatting, single leg step down).

healthy control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Reproducible pain with at least two of these activities: ascending or descending stairs or ramps, squatting, kneeling, prolonged sitting, hopping/ jumping, isometric quadriceps contraction or running
  • Clearly defined pain location in the peripatellar region
  • Reports of pain greater than 1 month duration.
  • They are able to perform squatting, running and MVC task- Participant response
  • Age range: 18-45 years old
  • Healthy and without any previous lower limb injuries
  • The participant is able to perform squatting, running and MVC task

You may not qualify if:

  • Previous history of knee surgery
  • Previous history of (traumatic) patella dislocation or instability
  • Previous history of ligamentous instabilities
  • Previous history of traumatic, inflammatory or infectious pathology in the lower extremity
  • Previous history of internal derangement or other causes
  • Previous diagnosed degenerative conditions in the knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salford

Salford, Greater Manchester, M66PU, United Kingdom

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, Principal Investigator

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations