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Neuromuscular Electrical Stimulation on Patellofemoral Pain

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ClinicalTrials.gov Identifier: NCT03918863
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

Brief Summary:
Objective this study is to analyze the effects of an intervention protocol with neuromuscular electrical stimulation in the vastus medialis obliquus and gluteus medius (GM) associated with exercises on electromyographic activity, muscle performance, self-reported functionality and pain of women with patellofemoral pain.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Neuromuscular electrical stimulation Other: Exercise Not Applicable

Detailed Description:
This is a randomized, blinded trial in which 40 women, aged 18-30 years, will be randomized into 2 groups: Stimulation and Exercise Group (SEG) - will perform an exercise protocol associated with stimulation in the vastus medialis (VM) and gluteus medius (GM) muscles. Exercises Group (ExG) - will perform the same protocol of exercises of the previous group, however, without association with neuromuscular electrical stimulation. The intervention will occur twice a week for eight weeks. All volunteers will be submitted to the evaluation of the electromyographic activity of the VM, the GM and the vastus lateralis, the dynamometric parameters, the intensity of the pain and the functionality, in four moments: 72h hours before the beginning of the intervention; after 4 weeks of intervention; after 8 weeks of intervention; after 16 weeks from the start of the intervention (eight weeks after the end of the protocol). In this way, the investigators will investigate the applicability of the proposed trial with the use of neuromuscular electrical stimulation and identify the effects of this resource in the treatment of PFP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Neuromuscular Electrical Stimulation Protocol in Women With Patellofemoral Pain
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neuromuscular electrical stimulation
8-week exercise program, twice a week, with neuromuscular eletrical stimulation on vastus medialis and gluteus medius.
Other: Neuromuscular electrical stimulation
Exercise protocol associated with neuromuscular electrical stimulation on vastus medialis and gluteus medius. Parameters: rectangular pulse shape, biphasic, symmetrical, pulse duration of 200μs, interbust interval of 10ms and frequency of 2.500Hz modulated in 50 bursts.
Other Name: Muscular eletrical stimulation

Active Comparator: Exercise
8-week exercise program, twice a week.
Other: Exercise
Same protocol of exercises of the other group, without association of electrical stimulation.




Primary Outcome Measures :
  1. Knee pain [ Time Frame: Change from baseline in knee pain at 8 weeks. ]
    Evaluation of pain level in the knee using the Numerical Pain Scale, graded from 0 to 10, where 0 indicates absence of pain and 10 indicates the worst pain imaginable.

  2. Knee function [ Time Frame: Change from baseline in knee function at 8 weeks. ]
    Evaluation of knee function using the Anterior Knee Pain Scale, that is a questionnaire encompassing 13 items related to different levels of knee function, with scores ranging from zero (representing the highest possible deficit) to 100 (meaning that the subject does not present any deficit).


Secondary Outcome Measures :
  1. Root Mean Square (RMS) [ Time Frame: Change from baseline in RMS at 8 weeks. ]
    Evaluation of the amplitude oh the electromyographic sinal (RMS) of vastus medialis, vastus lateralis and gluteus medius.

  2. Time of muscle activation (Onset) [ Time Frame: Change from baseline in onset of the electromyographic at 8 weeks. ]
    Evaluation of time of muscle activation electromyographic (onset) of vastus medialis, vastus lateralis and gluteus medius.

  3. Isokinetic performance [ Time Frame: Change from baseline in peak torque normalized for body weight at 8 weeks. ]
    Evaluation of isokinetic variable peak torque normalized for body weight (%) of knee extensors and hip abductors.

  4. Isokinetic performance [ Time Frame: Change from baseline in average peak torque at 8 weeks. ]
    Evaluation of isokinetic variable average peak torque (Nm) of knee extensors and hip abductors.

  5. Isokinetic performance [ Time Frame: Change from baseline in average power at 8 weeks. ]
    Evaluation of isokinetic variable average power (W) of knee extensors and hip abductors.

  6. Isokinetic performance [ Time Frame: Change from baseline in total work at 8 weeks. ]
    Evaluation of isokinetic variable total work (J) of knee extensors and hip abductors.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present anterior or retropatellar pain during at least two of the following functional activities: sitting for long periods, going up or down stairs, running, kneeling down, crouching or jumping;
  • A minimum pain score of three on the numerical pain scale, at the last 24 hours, with insidious and non-traumatic onset of symptoms for at least one month.

Exclusion Criteria:

  • History of surgery, trauma or an osteomioarticular system injury in the lower limbs in the last six months;
  • Other pathology associated with the knee joint and could not have performed physical therapy treatment in the last twelve weeks;
  • Body mass index greater than 30;
  • Pregnancy or breastfeeding;
  • Contraindications for the application of neuromuscular electrical stimulation;
  • Intolerance or non-acceptance of electric current;
  • Missing more than two intervention sessions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918863


Contacts
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Contact: Jamilson S Brasileiro, PhD 55+848433422008 brasileiro@ufrnet.br

Locations
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Brazil
Federal University of Rio Grande do Norte
Natal, RN, Brazil, 59140-840
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
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Principal Investigator: Jamilson S Brasileiro, PhD Universidade Federal do Rio Grande do Norte

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Responsible Party: Jamilson Simões Brasileiro, Professor, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03918863     History of Changes
Other Study ID Numbers: SAM2019
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte:
electromyography
physiotherapy
knee
quadriceps muscle
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases