Neuromuscular Electrical Stimulation on Patellofemoral Pain

Sponsor
Universidade Federal do Rio Grande do Norte (Other)
Overall Status
Unknown status
CT.gov ID
NCT03918863
Collaborator
(none)
40
2
2
17.3
20
1.2

Study Details

Study Description

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
  • Other: Neuromuscular electrical stimulation
  • Other: Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jun 24, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Knee pain [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 [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) [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) [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 [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 [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 [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 [Change from baseline in total work at 8 weeks.]

      Evaluation of isokinetic variable total work (J) of knee extensors and hip abductors.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade Federal do Rio Grande do Norte Natal Rio Grande Do Norte Brazil 59078-970
    2 Federal University of Rio Grande do Norte Natal RN Brazil 59140-840

    Sponsors and Collaborators

    • Universidade Federal do Rio Grande do Norte

    Investigators

    • Principal Investigator: Jamilson S Brasileiro, PhD, Universidade Federal do Rio Grande do Norte

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jamilson Simões Brasileiro, Professor, Universidade Federal do Rio Grande do Norte
    ClinicalTrials.gov Identifier:
    NCT03918863
    Other Study ID Numbers:
    • SAM2019
    First Posted:
    Apr 18, 2019
    Last Update Posted:
    Oct 22, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jamilson Simões Brasileiro, Professor, Universidade Federal do Rio Grande do Norte
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 22, 2019