Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

NCT ID: NCT02441712

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Motor PENS

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.

Group Type: EXPERIMENTAL

PENS

Intervention Type: DEVICE

Subsensory PENS

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

Group Type: SHAM_COMPARATOR

PENS

Intervention Type: DEVICE

Interventions

PENS

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accelerated Care Plus

INDUSTRY

Sponsor Role: collaborator

Mid-Atlantic Athletic Trainers' Association

UNKNOWN

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Susan Saliba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Saliba, PhD, ATC, PT

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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Other Identifiers

17909

Identifier Type: -

Identifier Source: org_study_id