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CompletedNCT02914574PFP-FPUpdated Mar 19, 2018

The Patellofemoral Pain Functional Performance Study

An interventional study of PowersTM strap in Patellofemoral Pain and Anterior Knee Pain, sponsored by University of Salford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-19.

Sponsored by University of Salford · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patellofemoral Pain
  • Anterior Knee Pain
03

In context

Patellofemoral Pain Syndrome

295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.

This study's enrollment of 21 is below the median of 45 across 242 interventional studies indexed under Patellofemoral Pain Syndrome.

Browse Patellofemoral Pain Syndrome studies →

Lead sponsor

University of Salford is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Other
    healthy control

    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

  • OtherPowersTM strap

    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).

06

What researchers measure

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

    Time frame: 1 day

07

Study locations

1 site
  • University of Salford
    Salford, Greater Manchester M66PU, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02914574
Lead sponsor
University of Salford
Responsible party
Henrike Greuel (PhD student, Principal Investigator, University of Salford) — Principal investigator
First posted
Sep 26, 2016
Start date
Jun 2016
Primary completion
Sep 2017
Completion
Oct 2017
Last update
Mar 19, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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