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Patellofemoral Pain SyndromePENS for PFPNCT02441712

Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

A study testing PENS in people with Patellofemoral Pain Syndrome, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 40 years
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
PENS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
Mar 2015to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Muscular abnormalities
  • Currently pregnant
  • Hypersensitivity to electrical stimulation
  • Active infection over the site of the electrode placement

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia

    Charlottesville, Virginia, 22902

Other trials in United States

About this study

Official title: 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.

Being tested
PENS
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PENSDevice

Study groups in NCT02441712
Study groupRoleWhat they receive
Motor PENSExperimentalMotor 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.
Receives: Device: PENS
Subsensory PENSSham comparatorSubsensory 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
Receives: Device: PENS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Pain Assessed by Visual Analog Scale (VAS)

    Current and Worse VAS

    Measured: Pain recorded by the VAS will be collected for 4 weeks

Secondary outcomes (13)

  1. 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

    Measured: Up to 4 weeks

  2. 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

    Measured: Up to 4 weeks

  3. 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

    Measured: Up to 4 weeks

  4. 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

    Measured: Up to 4 weeks

  5. Changes in Lower Extremity Electromyography during a step down task

    EMG activity of six lower extremity muscles during a step down task

    Measured: Up to 4 weeks

  6. Changes in Lower Extremity Electromyography during a single leg squat

    EMG activity of six lower extremity muscles during a single leg squat

    Measured: Up to 4 weeks

  7. Changes in Lower Extremity Electromyography during a lunge

    EMG activity of six lower extremity muscles during a lunge

    Measured: Up to 4 weeks

  8. Changes in Lower Extremity Electromyography during walking

    EMG activity of six lower extremity muscles during walking

    Measured: Up to 4 weeks

  9. Changes in Lower Extremity Electromyography during jogging

    EMG activity of six lower extremity muscles during jogging

    Measured: Up to 4 weeks

  10. 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.

    Measured: Up to 4 weeks

  11. Changes in lower extremity kinematics

    Trunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging

    Measured: Up to 4 weeks

  12. Changes in core strength

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

    Measured: Up to 4 weeks

  13. Changes in core activation

    Core activation will be assessed by real time ultrasound to examine the size of the core muscles

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441712
Sponsor's protocol ID
17909
Acronym
PENS for PFP
Status last verified
Oct 2017
First submitted
4 May 2015
Last updated
19 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22100617

  • 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.

    PubMed 21713229

  • 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.

    PubMed 19180213

  • 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.

    PubMed 17084115

  • 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.

    PubMed 25365133

  • 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.

    PubMed 21391799

  • 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.

    PubMed 20929936

  • 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.

    PubMed 11738950

  • 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.

    PubMed 24569145

  • 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.

    PubMed 22948078

  • 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.

    PubMed 19321908

  • 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.

    PubMed 25261089

  • 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.

    PubMed 23771827

  • 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.

    PubMed 22402604

  • 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.

    PubMed 21390470

Questions about this trial

What is this clinical trial studying?

A study testing PENS in people with Patellofemoral Pain Syndrome, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Pain Assessed by Visual Analog Scale (VAS) (time frame: Pain recorded by the VAS will be collected for 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441712, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.

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