Neuromuscular Electrical Stimulation on Patellofemoral Pain

Effects of a Neuromuscular Electrical Stimulation Protocol in Women With Patellofemoral Pain

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.

Study Overview

• Status: Unknown
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Other: Neuromuscular electrical stimulation; Other: Exercise

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RN
    • Natal, RN, Brazil, 59140-840
      • Recruiting
      • Federal University of Rio Grande do Norte
      • Contact: Jamilson S Brasileiro, PhD; Phone Number: +55 84 3342-2008; Email: brasileiro@ufrnet.br
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59078-970
      • Recruiting
      • Universidade Federal do Rio Grande do Norte
      • Contact: Jamilson Simões Brasileiro, PhD; Phone Number: +55 84 3342-2008; Email: brasileiro@ufrnet.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline in knee pain at 8 weeks.
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).	Change from baseline in knee function at 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root Mean Square (RMS)	Evaluation of the amplitude oh the electromyographic sinal (RMS) of vastus medialis, vastus lateralis and gluteus medius.	Change from baseline in RMS at 8 weeks.
Time of muscle activation (Onset)	Evaluation of time of muscle activation electromyographic (onset) of vastus medialis, vastus lateralis and gluteus medius.	Change from baseline in onset of the electromyographic at 8 weeks.
Isokinetic performance	Evaluation of isokinetic variable peak torque normalized for body weight (%) of knee extensors and hip abductors.	Change from baseline in peak torque normalized for body weight at 8 weeks.
Isokinetic performance	Evaluation of isokinetic variable average peak torque (Nm) of knee extensors and hip abductors.	Change from baseline in average peak torque at 8 weeks.
Isokinetic performance	Evaluation of isokinetic variable average power (W) of knee extensors and hip abductors.	Change from baseline in average power at 8 weeks.
Isokinetic performance	Evaluation of isokinetic variable total work (J) of knee extensors and hip abductors.	Change from baseline in total work at 8 weeks.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: knee; physiotherapy; electromyography; quadriceps muscle
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: SAM2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No