Skip to main content
OpenTrials
Completed

NCT Number: NCT02441712

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22902, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PENS

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Changes in Lower Extremity Electromyography during a lunge

    Time frame: Up to 4 weeks

    EMG activity of six lower extremity muscles during a lunge

  8. Changes in Lower Extremity Electromyography during walking

    Time frame: Up to 4 weeks

    EMG activity of six lower extremity muscles during walking

  9. Changes in Lower Extremity Electromyography during jogging

    Time frame: Up to 4 weeks

    EMG activity of six lower extremity muscles during jogging

  10. 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.

  11. 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

  12. Changes in core strength

    Time frame: Up to 4 weeks

    Trunk endurance will be assessed by front and side plank tasks.

  13. 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Accelerated Care Plus
  • Mid-Atlantic Athletic Trainers' Association

Registry information

Official study title

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

Acronym: PENS for PFP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 12, 2015
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.