Clinical trial NCT03918863: Neuromuscular Electrical Stimulation on Patellofemoral Pain
Official title: Effects of a Neuromuscular Electrical Stimulation Protocol in Women With Patellofemoral Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: electromyography
physiotherapy
knee
quadriceps muscle
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Knee pain
timeFrame: Change from baseline in knee pain at 8 weeks.
measure: Knee function
timeFrame: Change from baseline in knee function at 8 weeks.
Secondary outcomes:
measure: Root Mean Square (RMS)
timeFrame: Change from baseline in RMS at 8 weeks.
measure: Time of muscle activation (Onset)
timeFrame: Change from baseline in onset of the electromyographic at 8 weeks.
measure: Isokinetic performance
timeFrame: Change from baseline in peak torque normalized for body weight at 8 weeks.
measure: Isokinetic performance
timeFrame: Change from baseline in average peak torque at 8 weeks.
measure: Isokinetic performance
timeFrame: Change from baseline in average power at 8 weeks.
measure: Isokinetic performance
timeFrame: Change from baseline in total work at 8 weeks.
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte
state: Rio Grande Do Norte
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Jamilson S Brasileiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: