Patellofemoral Pain SyndromeNCT02548988
Selective Neuromuscular Electrical Stimulation on VMO
A study testing Neuromuscular Electrical Stimulation in people with Patellofemoral Pain Syndrome and Electric Stimulation, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is analyze the immediate effect of selective neuromuscular electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, Electric Stimulation
- What is being tested?
- Neuromuscular Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Dec 2015
- 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 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Healthy group:
- with no history of osteomyoarticular lesion or surgery in the lower limbs in the previous six months
- non-corrected neurological, vestibular, visual and/or hearing impairment
- For Patellofemoral pain syndrome group:
- clinical diagnosis of patellofemoral pain syndrome
- absence of other disorders in the knee
- refer pain at leafs two of the following activities: when remain seated for a long period, squat, kneel and go up or down stairs.
Who cannot join
- Individuals experiencing pain during collection procedures
- do not perform exercises as instructed by the researches
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte, 59078-970
About this study
Official title: Immediate Effect of Selective Neuromuscular Electrical Stimulation of Vastus Medialis Obliquus in Women With Patellofemoral Pain Syndrome
The purpose of this study is analyze the immediate effect of selective neuromuscular electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral pain syndrome.
- Conditions
- Patellofemoral Pain Syndrome, Electric Stimulation
- Being tested
- Neuromuscular Electrical Stimulation
- 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
Selective Neuromuscular Electrical Stimulation on VMO
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Healthy women are submitted to selective neuromuscular electrical stimulation on VMO. Receives: Other: Neuromuscular Electrical Stimulation |
| Patellofemoral pain syndrome | Experimental | Women with patellofemoral pain syndrome are submitted to selective neuromuscular electrical stimulation on VMO. Receives: Other: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity (root mean square - RMS) of vastus medialis obliquus
The immediate effect of neuromuscular electrical stimulation will be measured through surface electromyography and the variable analyzed will be root mean square (RMS).
Measured: Change from baseline in Electromyographic activity at 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548988
- Sponsor's protocol ID
- 056711/2015
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Selective Neuromuscular Electrical Stimulation of Vastus Medialis Obliquus in Women With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT02548988
- Acronym / sponsor ID
- 056711/2015
- Conditions
- Patellofemoral Pain Syndrome, Electric Stimulation
- 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
- Oct 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Sep 2015 (estimated)
- 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.
The purpose of this study is analyze the immediate effect of selective neuromuscular electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Other: Neuromuscular Electrical StimulationHealthy women are submitted to selective neuromuscular electrical stimulation on VMO. |
| Patellofemoral pain syndrome | Experimental | Other: Neuromuscular Electrical StimulationWomen with patellofemoral pain syndrome are submitted to selective neuromuscular electrical stimulation on VMO. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- For Healthy group:
- with no history of osteomyoarticular lesion or surgery in the lower limbs in the previous six months
- non-corrected neurological, vestibular, visual and/or hearing impairment
- For Patellofemoral pain syndrome group:
- clinical diagnosis of patellofemoral pain syndrome
Key exclusion criteria (2 listed)
- Individuals experiencing pain during collection procedures
- do not perform exercises as instructed by the researches
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 StimulationSelective Neuromuscular Electrical Stimulation on VMO | Other | Healthy, Patellofemoral pain syndrome |
Primary outcome
Electromyographic activity (root mean square - RMS) of vastus medialis obliquus
Time frame: Change from baseline in Electromyographic activity at 30 minutes
The immediate effect of neuromuscular electrical stimulation will be measured through surface electromyography and the variable analyzed will be root mean square (RMS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with Patellofemoral Pain Syndrome and Electric Stimulation, run by Universidade Federal do Rio Grande do Norte at 1 site 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 7 inclusion and 2 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 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic activity (root mean square - RMS) of vastus medialis obliquus (time frame: Change from baseline in Electromyographic activity at 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2015.