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Neuromuscular Electrical Stimulation on Patellofemoral Pain

Primary Purpose

Patellofemoral Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Exercise
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring electromyography, physiotherapy, knee, quadriceps muscle

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do NorteRecruiting
  • Federal University of Rio Grande do NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular electrical stimulation

Exercise

Arm Description

8-week exercise program, twice a week, with neuromuscular eletrical stimulation on vastus medialis and gluteus medius.

8-week exercise program, twice a week.

Outcomes

Primary Outcome Measures

Knee pain
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.
Knee function
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

Root Mean Square (RMS)
Evaluation of the amplitude oh the electromyographic sinal (RMS) of vastus medialis, vastus lateralis and gluteus medius.
Time of muscle activation (Onset)
Evaluation of time of muscle activation electromyographic (onset) of vastus medialis, vastus lateralis and gluteus medius.
Isokinetic performance
Evaluation of isokinetic variable peak torque normalized for body weight (%) of knee extensors and hip abductors.
Isokinetic performance
Evaluation of isokinetic variable average peak torque (Nm) of knee extensors and hip abductors.
Isokinetic performance
Evaluation of isokinetic variable average power (W) of knee extensors and hip abductors.
Isokinetic performance
Evaluation of isokinetic variable total work (J) of knee extensors and hip abductors.

Full Information

First Posted
April 2, 2019
Last Updated
October 19, 2019
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03918863
Brief Title
Neuromuscular Electrical Stimulation on Patellofemoral Pain
Official Title
Effects of a Neuromuscular Electrical Stimulation Protocol in Women With Patellofemoral Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
electromyography, physiotherapy, knee, quadriceps muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
8-week exercise program, twice a week, with neuromuscular eletrical stimulation on vastus medialis and gluteus medius.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
8-week exercise program, twice a week.
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation
Other Intervention Name(s)
Muscular eletrical stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Same protocol of exercises of the other group, without association of electrical stimulation.
Primary Outcome Measure Information:
Title
Knee pain
Description
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.
Time Frame
Change from baseline in knee pain at 8 weeks.
Title
Knee function
Description
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).
Time Frame
Change from baseline in knee function at 8 weeks.
Secondary Outcome Measure Information:
Title
Root Mean Square (RMS)
Description
Evaluation of the amplitude oh the electromyographic sinal (RMS) of vastus medialis, vastus lateralis and gluteus medius.
Time Frame
Change from baseline in RMS at 8 weeks.
Title
Time of muscle activation (Onset)
Description
Evaluation of time of muscle activation electromyographic (onset) of vastus medialis, vastus lateralis and gluteus medius.
Time Frame
Change from baseline in onset of the electromyographic at 8 weeks.
Title
Isokinetic performance
Description
Evaluation of isokinetic variable peak torque normalized for body weight (%) of knee extensors and hip abductors.
Time Frame
Change from baseline in peak torque normalized for body weight at 8 weeks.
Title
Isokinetic performance
Description
Evaluation of isokinetic variable average peak torque (Nm) of knee extensors and hip abductors.
Time Frame
Change from baseline in average peak torque at 8 weeks.
Title
Isokinetic performance
Description
Evaluation of isokinetic variable average power (W) of knee extensors and hip abductors.
Time Frame
Change from baseline in average power at 8 weeks.
Title
Isokinetic performance
Description
Evaluation of isokinetic variable total work (J) of knee extensors and hip abductors.
Time Frame
Change from baseline in total work at 8 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamilson S Brasileiro, PhD
Phone
55+848433422008
Email
brasileiro@ufrnet.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamilson S Brasileiro, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Norte
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59078-970
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamilson Simões Brasileiro, PhD
Phone
+55 84 3342-2008
Email
brasileiro@ufrnet.br
Facility Name
Federal University of Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59140-840
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamilson S Brasileiro, PhD
Phone
+55 84 3342-2008
Email
brasileiro@ufrnet.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuromuscular Electrical Stimulation on Patellofemoral Pain

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