Patellofemoral Pain SyndromeNCT03918863
Neuromuscular Electrical Stimulation on Patellofemoral Pain
A study testing Neuromuscular electrical stimulation and Exercise in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Rio Grande do Norte at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Neuromuscular electrical stimulation and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 24 Jun 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte, 59078-970
Jamilson Simões Brasileiro, PhD, +55 84 3342-2008, brasileiro@ufrnet.br
- Recruiting
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59140-840
Jamilson S Brasileiro, PhD, +55 84 3342-2008, brasileiro@ufrnet.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Neuromuscular electrical stimulation, Exercise
- Keywords
- electromyography, physiotherapy, knee, quadriceps muscle
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationOther
Also called Muscular eletrical 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.
ExerciseOther
Same protocol of exercises of the other group, without association of electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | 8-week exercise program, twice a week, with neuromuscular eletrical stimulation on vastus medialis and gluteus medius. Receives: Other: Neuromuscular electrical stimulation |
| Exercise | Active comparator | 8-week exercise program, twice a week. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Change from baseline in knee function at 8 weeks.
Secondary outcomes (6)
Root Mean Square (RMS)
Evaluation of the amplitude oh the electromyographic sinal (RMS) of vastus medialis, vastus lateralis and gluteus medius.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline in average power at 8 weeks.
Isokinetic performance
Evaluation of isokinetic variable total work (J) of knee extensors and hip abductors.
Measured: Change from baseline in total work at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start24 Jun 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
- Investigators
- Jamilson S Brasileiro, PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918863
- Sponsor's protocol ID
- SAM2019
- Status last verified
- May 2019
- First submitted
- 2 Apr 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38876657
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Neuromuscular Electrical Stimulation Protocol in Women With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT03918863
- Acronym / sponsor ID
- SAM2019
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- electromyography, physiotherapy, knee, quadriceps muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | Other: Neuromuscular electrical stimulation8-week exercise program, twice a week, with neuromuscular eletrical stimulation on vastus medialis and gluteus medius. |
| Exercise | Active comparator | Other: Exercise8-week exercise program, twice a week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationAlso: Muscular eletrical stimulationExercise 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 | Neuromuscular electrical stimulation |
| ExerciseSame protocol of exercises of the other group, without association of electrical stimulation. | Other | Exercise |
Primary outcome
Knee pain
Time frame: 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.
Knee function
Time frame: 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).
6 secondary outcomes
Root Mean Square (RMS)
Time frame: Change from baseline in RMS at 8 weeks.
Time of muscle activation (Onset)
Time frame: Change from baseline in onset of the electromyographic at 8 weeks.
Isokinetic performance
Time frame: Change from baseline in peak torque normalized for body weight at 8 weeks.
Isokinetic performance
Time frame: Change from baseline in average peak torque at 8 weeks.
Isokinetic performance
Time frame: Change from baseline in average power at 8 weeks.
Isokinetic performance
Time frame: Change from baseline in total work at 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 38876657Melo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamilson S Brasileiro, PhD principal investigator
Universidade Federal do Rio Grande do Norte
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation and Exercise in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Rio Grande do Norte at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamilson S Brasileiro, PhD (55+848433422008, brasileiro@ufrnet.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain (time frame: Change from baseline in knee pain at 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.