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The Patellofemoral Pain Functional Performance Study (PFP-FP)

Primary Purpose

Patellofemoral Pain, Anterior Knee Pain

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PowersTM strap
Sponsored by
University of Salford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for patients with PFP:

  1. 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
  2. Clearly defined pain location in the peripatellar region
  3. Reports of pain greater than 1 month duration.
  4. They are able to perform squatting, running and MVC task- Participant response
  5. Age range: 18-45 years old

Inclusion criteria for healthy volunteers:

  1. Healthy and without any previous lower limb injuries
  2. The participant is able to perform squatting, running and MVC task

Exclusion Criteria:

  1. Previous history of knee surgery
  2. Previous history of (traumatic) patella dislocation or instability
  3. Previous history of ligamentous instabilities
  4. Previous history of traumatic, inflammatory or infectious pathology in the lower extremity
  5. Previous history of internal derangement or other causes
  6. Previous diagnosed degenerative conditions in the knee
  7. Exclusion if patients cannot perform running, step down, or MVC task.
  8. Exclusion criteria for the healthy control group are: clinical evidence of other knee injury or knee pain, and current significant injury affecting other lower extremity joints.

Sites / Locations

  • University of Salford

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

healthy control

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 22, 2016
Last Updated
March 15, 2018
Sponsor
University of Salford
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1. Study Identification

Unique Protocol Identification Number
NCT02914574
Brief Title
The Patellofemoral Pain Functional Performance Study
Acronym
PFP-FP
Official Title
The Patellofemoral Pain Functional Performance and Arthrogenic Muscle Inhibition Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salford

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patellofemoral pain (PFP) is one of the most frequently diagnosed conditions in patients with knee complaints. Studies investigating the therapeutic effect on PFP revealed that the majority of patients with PFP were still suffering of knee pain after 5 to 8 years, despite initially received treatment and education, indicating that the current treatments fail to prevent the chronicity of symptoms. Considering that current treatment-strategies of patients with PFP seem to be unable to avoid the development of chronic symptoms, the question arises if the underlying factors of PFP are understood sufficiently. In contrary to the current broad body of literature on weakness, potentially underlying factors which might influence or even lead to PFP, such arthrogenic muscle inhibition (AMI) or the break phenomenon remain understudied. Pain in PFP has been proven to be linked to quadriceps strength deficit, gluteal strength deficits, knee stability, irregularities in the quadriceps torque curve, and functional performance. Bazett et al. (2011) described that pain "is more than a symptom and might play a role in the etiology or progression of PFP". Furthermore, pain seems to play a crucial role in AMI. However, the correlation between pain and AMI in patients with PFP has not been investigated currently. No assessment in isolation can provide a full picture of the problem. The combination of AMI, the break phenomenon with a biomechanical analysis might enable the determination of the impact of inhibition and strength on biomechanical changes. In addition, it might provide an answer to whether AMI or weakness cause biomechanical alterations, which would help to optimise treatment approaches in PFP. The PowersTM strap strap was developed with the aim of assisting lower limb kinematics, decreasing knee varus through supporting femoral abduction and external rotation. This treatment may potentially also directly improve functional performance. As the functional performance in participants with PFP after the application of the PowersTM strap has not been investigated, this study aims to analyse if there is a direct link between the application of the PowersTM strap to functional performance and pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain, Anterior Knee Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PowersTM strap
Intervention Description
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).
Primary Outcome Measure Information:
Title
Influence of Powers strap
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients with PFP: 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 Inclusion criteria for healthy volunteers: Healthy and without any previous lower limb injuries The participant is able to perform squatting, running and MVC task Exclusion Criteria: 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 Exclusion if patients cannot perform running, step down, or MVC task. Exclusion criteria for the healthy control group are: clinical evidence of other knee injury or knee pain, and current significant injury affecting other lower extremity joints.
Facility Information:
Facility Name
University of Salford
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M66PU
Country
United Kingdom

12. IPD Sharing Statement

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The Patellofemoral Pain Functional Performance Study

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