Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

Patellofemoral Pain Syndrome Clinical Trial

— PENS for PFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441712
• Other study ID #: 17909
• Status: Completed
• Phase: N/A
• First received: May 4, 2015
• Last updated: December 15, 2017
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome

Intervention

Device:
• PENS

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	Accelerated Care Plus, Mid-Atlantic Athletic Trainers' Association

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2011 Nov 15. — View Citation

Nakagawa TH, Maciel CD, Serrão 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. — View Citation

Nakagawa TH, Moriya ET, Maciel CD, Serrão 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. — View Citation

Nakagawa TH, Muniz TB, Baldon RM, Maciel CD, Amorim CF, Serrão 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. Epub 2011 Mar 4. — View Citation

Nakagawa TH, Serrão 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to 4 weeks
Secondary	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	Up to 4 weeks
Secondary	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	Up to 4 weeks
Secondary	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	Up to 4 weeks
Secondary	Changes in Lower Extremity Electromyography during a step down task	EMG activity of six lower extremity muscles during a step down task	Up to 4 weeks
Secondary	Changes in Lower Extremity Electromyography during a single leg squat	EMG activity of six lower extremity muscles during a single leg squat	Up to 4 weeks
Secondary	Changes in Lower Extremity Electromyography during a lunge	EMG activity of six lower extremity muscles during a lunge	Up to 4 weeks
Secondary	Changes in Lower Extremity Electromyography during walking	EMG activity of six lower extremity muscles during walking	Up to 4 weeks
Secondary	Changes in Lower Extremity Electromyography during jogging	EMG activity of six lower extremity muscles during jogging	Up to 4 weeks
Secondary	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.	Up to 4 weeks
Secondary	Changes in lower extremity kinematics	Trunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging	Up to 4 weeks
Secondary	Changes in core strength	Trunk endurance will be assessed by front and side plank tasks.	Up to 4 weeks
Secondary	Changes in core activation	Core activation will be assessed by real time ultrasound to examine the size of the core muscles	Up to 4 weeks