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

December 15, 2017 updated by: Susan Saliba, University of Virginia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: PENS
Sham Comparator: 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
Device: PENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Pain Assessed by Visual Analog Scale (VAS)
Time Frame: Pain recorded by the VAS will be collected for 4 weeks
Current and Worse VAS
Pain recorded by the VAS will be collected for 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quadriceps Muscle Strength
Time Frame: Up to 4 weeks
Muscle strength of the quadriceps will be measured by individuals performing a maximum contraction against a small device that will measure force output
Up to 4 weeks
Changes in Hamstring Muscle Strength
Time Frame: Up to 4 weeks
Muscle strength of the hamstring will be measured by individuals performing a maximum contraction against a small device that will measure force output
Up to 4 weeks
Changes in Gluteus Medius Muscle Strength
Time Frame: Up to 4 weeks
Muscle strength of the gluteus medius will be measured by individuals performing a maximum contraction against a small device that will measure force output
Up to 4 weeks
Changes in Hip Adductor Muscle Strength
Time Frame: Up to 4 weeks
Muscle strength of the hip adductors will be measured by individuals performing a maximum contraction against a small device that will measure force output
Up to 4 weeks
Changes in Lower Extremity Electromyography during a step down task
Time Frame: Up to 4 weeks
EMG activity of six lower extremity muscles during a step down task
Up to 4 weeks
Changes in Lower Extremity Electromyography during a single leg squat
Time Frame: Up to 4 weeks
EMG activity of six lower extremity muscles during a single leg squat
Up to 4 weeks
Changes in Lower Extremity Electromyography during a lunge
Time Frame: Up to 4 weeks
EMG activity of six lower extremity muscles during a lunge
Up to 4 weeks
Changes in Lower Extremity Electromyography during walking
Time Frame: Up to 4 weeks
EMG activity of six lower extremity muscles during walking
Up to 4 weeks
Changes in Lower Extremity Electromyography during jogging
Time Frame: Up to 4 weeks
EMG activity of six lower extremity muscles during jogging
Up to 4 weeks
Changes in Patient reported outcomes
Time Frame: Up to 4 weeks
4 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.
Up to 4 weeks
Changes in lower extremity kinematics
Time Frame: Up to 4 weeks
Trunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging
Up to 4 weeks
Changes in core strength
Time Frame: Up to 4 weeks
Trunk endurance will be assessed by front and side plank tasks.
Up to 4 weeks
Changes in core activation
Time Frame: Up to 4 weeks
Core activation will be assessed by real time ultrasound to examine the size of the core muscles
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Accelerated Care Plus
Mid-Atlantic Athletic Trainers' Association

Investigators

  • Principal Investigator: Susan Saliba, PhD, ATC, PT, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 15, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patellofemoral Pain Syndrome

Clinical Trials on PENS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe