TorqueNCT01862393
Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris
A study testing 400 microseconds, 700 microseconds and 1000 microseconds in people with Torque and Pain Perception, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Torque, Pain Perception
- What is being tested?
- 400 microseconds, 700 microseconds and 1000 microseconds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Dec 2008
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sedentary healthy university students.
Who cannot join
- history of knee surgery or injury,
- musculoskeletal, cardiovascular or neurological disease including impaired sensation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris
This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.
- Conditions
- Torque, Pain Perception
- Being tested
- 400 microseconds, 700 microseconds, 1000 microseconds
- Keywords
- electrical stimulation, torque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 microsecondsDevice
Neuromuscular electrical stimulation with stimulus phase duration of 400 microseconds
700 microsecondsDevice
Neuromuscular electrical stimulation with stimulus phase duration of 700 microseconds
1000 microsecondsDevice
Neuromuscular electrical stimulation with stimulus phase duration of 1000 microseconds
| Study group | Role | What they receive |
|---|---|---|
| 400 microseconds | Experimental | Electrically-induced torque generated with stimulus phase duration set at 400 microseconds. Receives: Device: 400 microseconds |
| 700 microseconds | Experimental | Electrically-induced torque generated with stimulus phase duration set at 700 microseconds. Receives: Device: 700 microseconds |
| 1000 microseconds | Experimental | Electrically-induced torque generated with stimulus phase duration set at 1000 microseconds. Receives: Device: 1000 microseconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Torque
Torque will be measured using an isokinetic dynamometer. Torque will be registered in Newton meter [N.m]
Measured: During 4 seconds of electrical stimulation
Secondary outcomes (1)
Discomfort
Discomfort will be measured using a 10 cm visual analogue scale (VAS) ranging from zero (no discomfort) to 10 (worst discomfort imaginable).
Measured: During 6 seconds of electrical stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TorqueStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Eloin Liebano, Universidade Cidade de Sao Paulo
- Investigators
- Richard E Liebano, PhD, Principal investigator, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862393
- Sponsor's protocol ID
- CAAE - 0081.0.186.000-07
- Status last verified
- Aug 2016
- First submitted
- 17 May 2013
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris
- ClinicalTrials.gov ID
- NCT01862393
- Acronym / sponsor ID
- CAAE - 0081.0.186.000-07
- Conditions
- Torque, Pain Perception
- Keywords
- electrical stimulation, torque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 May 2013 (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.
This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 microseconds | Experimental | Device: 400 microsecondsElectrically-induced torque generated with stimulus phase duration set at 400 microseconds. |
| 700 microseconds | Experimental | Device: 700 microsecondsElectrically-induced torque generated with stimulus phase duration set at 700 microseconds. |
| 1000 microseconds | Experimental | Device: 1000 microsecondsElectrically-induced torque generated with stimulus phase duration set at 1000 microseconds. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- sedentary healthy university students.
Key exclusion criteria (2 listed)
- history of knee surgery or injury,
- musculoskeletal, cardiovascular or neurological disease including impaired sensation.
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 |
|---|---|---|
| 400 microsecondsNeuromuscular electrical stimulation with stimulus phase duration of 400 microseconds | Device | 400 microseconds |
| 700 microsecondsNeuromuscular electrical stimulation with stimulus phase duration of 700 microseconds | Device | 700 microseconds |
| 1000 microsecondsNeuromuscular electrical stimulation with stimulus phase duration of 1000 microseconds | Device | 1000 microseconds |
Primary outcome
Torque
Time frame: During 4 seconds of electrical stimulation
Torque will be measured using an isokinetic dynamometer. Torque will be registered in Newton meter [N.m]
1 secondary outcome
Discomfort
Time frame: During 6 seconds of electrical stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Richard E Liebano, PhD principal investigator
Universidade Cidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400 microseconds, 700 microseconds and 1000 microseconds in people with Torque and Pain Perception, run by Universidade Cidade de Sao Paulo 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 1 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: finished, as of the sponsor's last update on 1 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Torque (time frame: During 4 seconds of electrical stimulation). 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 1 Sep 2016.