Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain (PENS for PFP)

University of Virginia

Status: Completed

Conditions: Patellofemoral Pain Syndrome

Treatments: Device: PENS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02441712

17909

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Motor PENS

Experimental group

Description:

Motor PENS will be a strong tri-phasic stimulation pattern to the hip, quadriceps, hamstring, and adductors for strength training (50Hz impulses for 200ms every 1500 ms). The stimulus will be administered for 15-minutes followed by the impairment rehabilitation program.

Treatment:

Device: PENS

Subsensory PENS

Sham Comparator group

Description:

Subsensory PENS will be a sub sensory stimulus also administered by a tri-phasic stimulation pattern to the hip, quadriceps, hamstring, and adductors (50Hz impulses for 200ms every 1500ms). The stimulus will be administered for 15-minutes followed by the impairment rehabilitation program

Treatment:

Device: PENS