HealthyNCT01950728
Electrical Currents on Hypoalgesia
A study testing Interferential current, Aussie Current and TENS in people with Healthy, run by Fabio Massao Matuzawa at 1 site in Brazil.
Trial summary
The objective of this study is to compare the hypoalgesic effects of TENS, Interferential current and Aussie current in pressure pain threshold and sensory discomfort in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Interferential current, Aussie Current and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2017to 23 Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- health adults
Who cannot join
- injury to nerves of the upper limbs, pain, pregnancy, chronic diseases, cardiac pacemaker, epilepsy, allergy to the electrode used, use of pain medication, skin lesions or lack of sensitivity in the areas of electrode placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoalgesic Effect of Low Frequency and Burst Modulated Alternating Currents on Healthy Individuals.
The objective of this study is to compare the hypoalgesic effects of TENS, Interferential current and Aussie current in pressure pain threshold and sensory discomfort in healthy subjects.
- Conditions
- Healthy
- Being tested
- Interferential current, Aussie Current, TENS
- Keywords
- volunteers, 18 to 65 years, Males and Females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential currentDevice
Interferential current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kilohertz (kHz) and modulated frequency will be set at 100 Hz.
Aussie CurrentDevice
Aussie current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kHz and modulated frequency will be set at 100 Hz.
TENSDevice
TENS will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Pulse duration will be set at 125 microseconds and frequency will be set at 100 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group will not receive electrical stimulation. Volunteers will rest during 30 minutes. |
| Interferential current group | Active comparator | Interferential current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia. Receives: Device: Interferential current |
| TENS Group | Active comparator | TENS will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia. Receives: Device: TENS |
| Aussie current group | Active comparator | Aussie current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia. Receives: Device: Aussie Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
Pressure Pain Threshold will be measured using a digital pressure algometer SOMEDIC type II. The applied force will be measured in Newton (N).
Measured: Baseline, 15 minutes after the beginning of electrical stimulation, 30 minutes after the beginning of electrical stimulation, and 20 minutes after electrical stimulation.
Secondary outcomes (1)
Sensory Discomfort
Sensory Discomfort will be measured using a 10 cm visual analogue scale (VAS). The degree of discomfort will be measured in centimeters (cm).
Measured: 15 and 30 minutes after the beginning 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 posted25 Sep 2013 (estimated)
- Study start25 Sep 2017
- Primary completion18 Dec 2017
- Study completion23 Jan 2018
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 HealthyStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio Massao Matuzawa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabio Massao Matuzawa, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950728
- Sponsor's protocol ID
- 14571013.1.0000.5512
- Status last verified
- Jan 2018
- First submitted
- 23 Sep 2013
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rampazo da Silva EP, da Silva VR, Bernardes AS, Matuzawa FM, Liebano RE. Study protocol of hypoalgesic effects of low frequency and burst-modulated alternating currents on healthy individuals. Pain Manag. 2018 Mar;8(2):71-77. doi: 10.2217/pmt-2017-0058. Epub 2018 Feb 16.
PubMed 29451431
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoalgesic Effect of Low Frequency and Burst Modulated Alternating Currents on Healthy Individuals.
- ClinicalTrials.gov ID
- NCT01950728
- Acronym / sponsor ID
- 14571013.1.0000.5512
- Conditions
- Healthy
- Keywords
- volunteers, 18 to 65 years, Males and Females
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fabio Massao MatuzawaUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 25 Sep 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.
The objective of this study is to compare the hypoalgesic effects of TENS, Interferential current and Aussie current in pressure pain threshold and sensory discomfort in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group will not receive electrical stimulation. Volunteers will rest during 30 minutes. |
| Interferential current group | Active comparator | Device: Interferential currentInterferential current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia. |
| TENS Group | Active comparator | Device: TENSTENS will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia. |
| Aussie current group | Active comparator | Device: Aussie CurrentAussie current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- health adults
Key exclusion criteria (1 listed)
- injury to nerves of the upper limbs, pain, pregnancy, chronic diseases, cardiac pacemaker, epilepsy, allergy to the electrode used, use of pain medication, skin lesions or lack of sensitivity in the areas of electrode placement
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 |
|---|---|---|
| Interferential currentInterferential current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kilohertz (kHz) and modulated frequency will be set at 100 Hz. | Device | Interferential current group |
| Aussie CurrentAussie current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kHz and modulated frequency will be set at 100 Hz. | Device | Aussie current group |
| TENSTENS will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Pulse duration will be set at 125 microseconds and frequency will be set at 100 Hz. | Device | TENS Group |
Primary outcome
Pressure Pain Threshold
Time frame: Baseline, 15 minutes after the beginning of electrical stimulation, 30 minutes after the beginning of electrical stimulation, and 20 minutes after electrical stimulation.
Pressure Pain Threshold will be measured using a digital pressure algometer SOMEDIC type II. The applied force will be measured in Newton (N).
1 secondary outcome
Sensory Discomfort
Time frame: 15 and 30 minutes after the beginning 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 24 Jan 2018.
- Derived from this study: PubMed 29451431Rampazo da Silva EP, da Silva VR, Bernardes AS, Matuzawa FM, Liebano RE. Study protocol of hypoalgesic effects of low frequency and burst-modulated alternating currents on healthy individuals. Pain Manag. 2018 Mar;8(2):71-77. doi: 10.2217/pmt-2017-0058. Epub 2018 Feb 16.
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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 Interferential current, Aussie Current and TENS in people with Healthy, run by Fabio Massao Matuzawa 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 1 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 24 Jan 2018. 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?
Pressure Pain Threshold (time frame: Baseline, 15 minutes after the beginning of electrical stimulation, 30 minutes after the beginning of electrical stimulation, and 20 minutes after electrical stimulation.). 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 NCT01950728, 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 24 Jan 2018.