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Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

Supervised Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02441712
Acronym
PENS for PFP
Enrollment
21
Registered
2015-05-12
Start date
2015-03-31
Completion date
2017-12-31
Last updated
2017-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral Pain Syndrome

Brief summary

This is a Randomized Controlled Trial (RCT) regarding the conservative treatment of patellofemoral pain (PFP) with an impairment based rehabilitation program. Those with PFP can have a variety of impairments, such as knee and hip muscle weakness, poor movement patterns, weak core activation and muscle tightness. Several recent RCT trials have looked at treating single impairments, but to date no RCT have address individualized patient impairments during a rehabilitation program. Abnormal muscle firing patterns have also been identified during functional tasks; such as jogging, stair climbing, and performing a single leg squat. Conflicting studies have produced changes to the quadriceps and hip muscle firing patterns with those with PFP. The abnormal activation patterns has been suggested to be why strengthening programs alone do not improve movement patterns during functional tasks for those with PFP. Patterned electrical neuromuscular stimulation (PENS) is a novel form of electrical stimulation that replicates proper firing patterns based off healthy electromyography patterns. The purpose of the study is to investigate the benefits of PENS with a impairment based rehabilitation program for the treatment of PFP. The rationale for this investigation is to assess the benefits of PENS with therapeutic exercise at improving altered firing patterns of the lower extremity muscles during functional tasks.

Interventions

DEVICEPENS

Sponsors

Accelerated Care Plus
CollaboratorINDUSTRY
Mid-Atlantic Athletic Trainers' Association
CollaboratorUNKNOWN
University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Insidious onset of symptoms * Presence of peri- or retro patellar knee pain during at least two of the following functional activities: Stair ascent or descent, Running, Kneeling, Squatting, Prolonged sitting, Jumping * Pain for more than 3 months * Pain \>3/10 on VAS * 85 or less on the Anterior Knee Pain Scale

Exclusion criteria

* Previous knee surgery * Internal Derangement * Ligamentous instability * Other sources of anterior knee pain(patella tendonitis, osgood schlatter, knee plica, etc) * Neurological Involvement * Any biomedical device * Muscular abnormalities * Currently pregnant * Hypersensitivity to electrical stimulation * Active infection over the site of the electrode placement

Design outcomes

Primary

MeasureTime frameDescription
Changes in Pain Assessed by Visual Analog Scale (VAS)Pain recorded by the VAS will be collected for 4 weeksCurrent and Worse VAS

Secondary

MeasureTime frameDescription
Changes in Patient reported outcomesUp to 4 weeks4 patient reported outcomes on pain and function before and after the intervention. These patient reported outcomes are the Anterior Knee Pain Scale, the Activities of Daily Living Scale, the Godin Leisure Scale, and the Fear Avoidance Belief Questionnaire.
Changes in lower extremity kinematicsUp to 4 weeksTrunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging
Changes in core strengthUp to 4 weeksTrunk endurance will be assessed by front and side plank tasks.
Changes in Quadriceps Muscle StrengthUp to 4 weeksMuscle strength of the quadriceps will be measured by individuals performing a maximum contraction against a small device that will measure force output
Changes in Hamstring Muscle StrengthUp to 4 weeksMuscle strength of the hamstring will be measured by individuals performing a maximum contraction against a small device that will measure force output
Changes in Gluteus Medius Muscle StrengthUp to 4 weeksMuscle strength of the gluteus medius will be measured by individuals performing a maximum contraction against a small device that will measure force output
Changes in core activationUp to 4 weeksCore activation will be assessed by real time ultrasound to examine the size of the core muscles
Changes in Lower Extremity Electromyography during a step down taskUp to 4 weeksEMG activity of six lower extremity muscles during a step down task
Changes in Lower Extremity Electromyography during a single leg squatUp to 4 weeksEMG activity of six lower extremity muscles during a single leg squat
Changes in Lower Extremity Electromyography during a lungeUp to 4 weeksEMG activity of six lower extremity muscles during a lunge
Changes in Lower Extremity Electromyography during walkingUp to 4 weeksEMG activity of six lower extremity muscles during walking
Changes in Lower Extremity Electromyography during joggingUp to 4 weeksEMG activity of six lower extremity muscles during jogging
Changes in Hip Adductor Muscle StrengthUp to 4 weeksMuscle strength of the hip adductors will be measured by individuals performing a maximum contraction against a small device that will measure force output

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026