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

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PENS
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Motor PENS

Subsensory PENS

Arm 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.

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

Outcomes

Primary Outcome Measures

Changes in Pain Assessed by Visual Analog Scale (VAS)
Current and Worse VAS

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2015
Last Updated
December 15, 2017
Sponsor
University of Virginia
Collaborators
Accelerated Care Plus, Mid-Atlantic Athletic Trainers' Association
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1. Study Identification

Unique Protocol Identification Number
NCT02441712
Brief Title
Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
Acronym
PENS for PFP
Official Title
Supervised Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Accelerated Care Plus, Mid-Atlantic Athletic Trainers' Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor PENS
Arm Type
Experimental
Arm 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.
Arm Title
Subsensory PENS
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
PENS
Primary Outcome Measure Information:
Title
Changes in Pain Assessed by Visual Analog Scale (VAS)
Description
Current and Worse VAS
Time Frame
Pain recorded by the VAS will be collected for 4 weeks
Secondary Outcome Measure Information:
Title
Changes in Quadriceps Muscle Strength
Description
Muscle strength of the quadriceps will be measured by individuals performing a maximum contraction against a small device that will measure force output
Time Frame
Up to 4 weeks
Title
Changes in Hamstring Muscle Strength
Description
Muscle strength of the hamstring will be measured by individuals performing a maximum contraction against a small device that will measure force output
Time Frame
Up to 4 weeks
Title
Changes in Gluteus Medius Muscle Strength
Description
Muscle strength of the gluteus medius will be measured by individuals performing a maximum contraction against a small device that will measure force output
Time Frame
Up to 4 weeks
Title
Changes in Hip Adductor Muscle Strength
Description
Muscle strength of the hip adductors will be measured by individuals performing a maximum contraction against a small device that will measure force output
Time Frame
Up to 4 weeks
Title
Changes in Lower Extremity Electromyography during a step down task
Description
EMG activity of six lower extremity muscles during a step down task
Time Frame
Up to 4 weeks
Title
Changes in Lower Extremity Electromyography during a single leg squat
Description
EMG activity of six lower extremity muscles during a single leg squat
Time Frame
Up to 4 weeks
Title
Changes in Lower Extremity Electromyography during a lunge
Description
EMG activity of six lower extremity muscles during a lunge
Time Frame
Up to 4 weeks
Title
Changes in Lower Extremity Electromyography during walking
Description
EMG activity of six lower extremity muscles during walking
Time Frame
Up to 4 weeks
Title
Changes in Lower Extremity Electromyography during jogging
Description
EMG activity of six lower extremity muscles during jogging
Time Frame
Up to 4 weeks
Title
Changes in Patient reported outcomes
Description
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.
Time Frame
Up to 4 weeks
Title
Changes in lower extremity kinematics
Description
Trunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging
Time Frame
Up to 4 weeks
Title
Changes in core strength
Description
Trunk endurance will be assessed by front and side plank tasks.
Time Frame
Up to 4 weeks
Title
Changes in core activation
Description
Core activation will be assessed by real time ultrasound to examine the size of the core muscles
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Saliba, PhD, ATC, PT
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22100617
Citation
Macrum E, Bell DR, Boling M, Lewek M, Padua D. Effect of limiting ankle-dorsiflexion range of motion on lower extremity kinematics and muscle-activation patterns during a squat. J Sport Rehabil. 2012 May;21(2):144-50. doi: 10.1123/jsr.21.2.144. Epub 2011 Nov 15.
Results Reference
background
PubMed Identifier
21713229
Citation
Bolgla LA, Boling MC. An update for the conservative management of patellofemoral pain syndrome: a systematic review of the literature from 2000 to 2010. Int J Sports Phys Ther. 2011 Jun;6(2):112-25.
Results Reference
background
PubMed Identifier
19180213
Citation
Boling MC, Padua DA, Alexander Creighton R. Concentric and eccentric torque of the hip musculature in individuals with and without patellofemoral pain. J Athl Train. 2009 Jan-Feb;44(1):7-13. doi: 10.4085/1062-6050-44.1.7.
Results Reference
background
PubMed Identifier
17084115
Citation
Boling MC, Bolgla LA, Mattacola CG, Uhl TL, Hosey RG. Outcomes of a weight-bearing rehabilitation program for patients diagnosed with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2006 Nov;87(11):1428-35. doi: 10.1016/j.apmr.2006.07.264.
Results Reference
background
PubMed Identifier
25365133
Citation
Ferber R, Bolgla L, Earl-Boehm JE, Emery C, Hamstra-Wright K. Strengthening of the hip and core versus knee muscles for the treatment of patellofemoral pain: a multicenter randomized controlled trial. J Athl Train. 2015 Apr;50(4):366-77. doi: 10.4085/1062-6050-49.3.70. Epub 2014 Nov 3.
Results Reference
background
PubMed Identifier
21391799
Citation
Ferber R, Kendall KD, Farr L. Changes in knee biomechanics after a hip-abductor strengthening protocol for runners with patellofemoral pain syndrome. J Athl Train. 2011 Mar-Apr;46(2):142-9. doi: 10.4085/1062-6050-46.2.142.
Results Reference
background
PubMed Identifier
20929936
Citation
Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.
Results Reference
background
PubMed Identifier
11738950
Citation
Earl JE, Schmitz RJ, Arnold BL. Activation of the VMO and VL during dynamic mini-squat exercises with and without isometric hip adduction. J Electromyogr Kinesiol. 2001 Dec;11(6):381-6. doi: 10.1016/s1050-6411(01)00024-4.
Results Reference
background
PubMed Identifier
24569145
Citation
Witvrouw E, Callaghan MJ, Stefanik JJ, Noehren B, Bazett-Jones DM, Willson JD, Earl-Boehm JE, Davis IS, Powers CM, McConnell J, Crossley KM. Patellofemoral pain: consensus statement from the 3rd International Patellofemoral Pain Research Retreat held in Vancouver, September 2013. Br J Sports Med. 2014 Mar;48(6):411-4. doi: 10.1136/bjsports-2014-093450. No abstract available.
Results Reference
background
PubMed Identifier
22948078
Citation
Willson JD, Petrowitz I, Butler RJ, Kernozek TW. Male and female gluteal muscle activity and lower extremity kinematics during running. Clin Biomech (Bristol, Avon). 2012 Dec;27(10):1052-7. doi: 10.1016/j.clinbiomech.2012.08.008. Epub 2012 Sep 1.
Results Reference
background
PubMed Identifier
19321908
Citation
Willson JD, Davis IS. Lower extremity strength and mechanics during jumping in women with patellofemoral pain. J Sport Rehabil. 2009 Feb;18(1):76-90. doi: 10.1123/jsr.18.1.76.
Results Reference
background
PubMed Identifier
25261089
Citation
Nakagawa TH, Maciel CD, Serrao FV. Trunk biomechanics and its association with hip and knee kinematics in patients with and without patellofemoral pain. Man Ther. 2015 Feb;20(1):189-93. doi: 10.1016/j.math.2014.08.013. Epub 2014 Sep 9.
Results Reference
background
PubMed Identifier
23771827
Citation
Nakagawa TH, Serrao FV, Maciel CD, Powers CM. Hip and knee kinematics are associated with pain and self-reported functional status in males and females with patellofemoral pain. Int J Sports Med. 2013 Nov;34(11):997-1002. doi: 10.1055/s-0033-1334966. Epub 2013 Jun 14.
Results Reference
background
PubMed Identifier
22402604
Citation
Nakagawa TH, Moriya ET, Maciel CD, Serrao FV. Trunk, pelvis, hip, and knee kinematics, hip strength, and gluteal muscle activation during a single-leg squat in males and females with and without patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2012 Jun;42(6):491-501. doi: 10.2519/jospt.2012.3987. Epub 2012 Mar 8.
Results Reference
background
PubMed Identifier
21390470
Citation
Nakagawa TH, Muniz TB, Baldon RM, Maciel CD, Amorim CF, Serrao FV. Electromyographic preactivation pattern of the gluteus medius during weight-bearing functional tasks in women with and without anterior knee pain. Rev Bras Fisioter. 2011 Jan-Feb;15(1):59-65. doi: 10.1590/s1413-35552011005000003. Epub 2011 Mar 4.
Results Reference
background
PubMed Identifier
25155651
Citation
Teng HL, Powers CM. Sagittal plane trunk posture influences patellofemoral joint stress during running. J Orthop Sports Phys Ther. 2014 Oct;44(10):785-92. doi: 10.2519/jospt.2014.5249. Epub 2014 Aug 25.
Results Reference
background
PubMed Identifier
30721093
Citation
Glaviano NR, Marshall AN, Mangum LC, Hart JM, Hertel J, Russell S, Saliba SA. Impairment-Based Rehabilitation With Patterned Electrical Neuromuscular Stimulation and Lower Extremity Function in Individuals With Patellofemoral Pain: A Preliminary Study. J Athl Train. 2019 Mar;54(3):255-269. doi: 10.4085/1062-6050-490-17. Epub 2019 Feb 5.
Results Reference
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Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

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