The Patellofemoral Pain Functional Performance Study

NCT ID: NCT02914574

Last Updated: 2018-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patellofemoral Pain Anterior Knee Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

PowersTM strap

Intervention Type OTHER

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PowersTM 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Salford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Henrike Greuel

PhD student, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Salford

Salford, Greater Manchester, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSCR15-143

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.