Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

NCT02441712 | Completed DMC

• 1 other identifier: 17909
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in Pain Assessed by Visual Analog Scale (VAS)

  Current and Worse VAS

  Pain recorded by the VAS will be collected for 4 weeks

Secondary Outcomes (13)

• Changes in Quadriceps Muscle Strength

  Up to 4 weeks

• Changes in Hamstring Muscle Strength

  Up to 4 weeks

• Changes in Gluteus Medius Muscle Strength

  Up to 4 weeks

• Changes in Hip Adductor Muscle Strength

  Up to 4 weeks

• Changes in Lower Extremity Electromyography during a step down task

  Up to 4 weeks

Study Arms (2)

Motor PENS

EXPERIMENTAL

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

Subsensory PENS

SHAM COMPARATOR

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

Interventions

PENS DEVICE

Motor PENS; Subsensory PENS

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• or less on the Anterior Knee Pain Scale

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Accelerated Care Plus: collaborator
• Mid-Atlantic Athletic Trainers' Association: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22902, United States

Location

Related Publications (17)

• 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.

  PMID: 22100617 BACKGROUND

• 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.

  PMID: 21713229 BACKGROUND

• 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.

  PMID: 19180213 BACKGROUND

• 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.

  PMID: 17084115 BACKGROUND

• 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.

  PMID: 25365133 BACKGROUND

• 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.

  PMID: 21391799 BACKGROUND

• 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.

  PMID: 20929936 BACKGROUND

• 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.

  PMID: 11738950 BACKGROUND

• 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.

  PMID: 24569145 BACKGROUND

• Willson JD, Petrowitz I, Butler RJ, Kernozek TW. Male and female gluteal muscle activity and lower extremity kinematics during running. Clin Biomech (Bristol). 2012 Dec;27(10):1052-7. doi: 10.1016/j.clinbiomech.2012.08.008. Epub 2012 Sep 1.

  PMID: 22948078 BACKGROUND

• 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.

  PMID: 19321908 BACKGROUND

• 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.

  PMID: 25261089 BACKGROUND

• 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.

  PMID: 23771827 BACKGROUND

• 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.

  PMID: 22402604 BACKGROUND

• 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.

  PMID: 21390470 BACKGROUND

• 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.

  PMID: 25155651 BACKGROUND

• 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.

  PMID: 30721093 DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Susan Saliba, PhD, ATC, PT

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-10

Locations

US (1)