NCT03918863

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 22, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

April 2, 2019

Last Update Submit

October 19, 2019

Conditions

Keywords

electromyographyphysiotherapykneequadriceps muscle

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Root Mean Square (RMS)

    Change from baseline in RMS at 8 weeks.

  • Time of muscle activation (Onset)

    Change from baseline in onset of the electromyographic at 8 weeks.

  • Isokinetic performance

    Change from baseline in peak torque normalized for body weight at 8 weeks.

  • Isokinetic performance

    Change from baseline in average peak torque at 8 weeks.

  • Isokinetic performance

    Change from baseline in average power at 8 weeks.

  • +1 more secondary outcomes

Study Arms (2)

Neuromuscular electrical stimulation

EXPERIMENTAL

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

Other: Neuromuscular electrical stimulation

Exercise

ACTIVE COMPARATOR

8-week exercise program, twice a week.

Other: Exercise

Interventions

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.

Also known as: Muscular eletrical stimulation
Neuromuscular electrical stimulation

Same protocol of exercises of the other group, without association of electrical stimulation.

Exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, 59078-970, Brazil

RECRUITING

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59140-840, Brazil

RECRUITING

Related Publications (1)

  • Melo SA, Macedo LB, Bullhoes LCC, Cavalcanti RL, Azevedo Rodolfo JI, Brasileiro JS. Effects of neuromuscular electrical stimulation on patellofemoral pain: A randomized controlled trial. J Bodyw Mov Ther. 2024 Jul;39:390-397. doi: 10.1016/j.jbmt.2024.03.022. Epub 2024 Mar 19.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jamilson S Brasileiro, PhD

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamilson S Brasileiro, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 18, 2019

Study Start

June 24, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 22, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations