Effects of TENS on Sympathetic Skin ResponseNCT01696149
Effects of High and Low Frequency TENS on Sympathetic Skin Response and Skin Temperature
A study testing transcutaneous electrical nerve stimulation in people with Effects of TENS on Sympathetic Skin Response, run by Shiraz University of Medical Sciences.
Trial summary
The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic skin response (SSR) and skin temperature. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Effects of TENS on Sympathetic Skin Response
- What is being tested?
- transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jun 2011
- 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 18 to 30 years
Who cannot join
- History of cardiovascular, neurologic or musculoskeletal disease
- Taking medication at the time of the study
About this study
Official title: The Effects of High and Low Frequency Transcutaneous Electrical Nerve Stimulation on Sympathetic Skin Response and Skin Temperature
The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic skin response (SSR) and skin temperature.
Read the detailed description
15 healthy subjects (8 females, 7 males) with a mean age of 22.6 ± 3.7 years participated in this study.
All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.
Outcome measures: Sympathetic skin response from the simulated (Right) hand and skin temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.
- Being tested
- transcutaneous electrical nerve stimulation
- Keywords
- TENS, sympathetic skin response, skin temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulationDevice
Also called TENS
All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.
| Study group | Role | What they receive |
|---|---|---|
| electrical nerve stimulation | Experimental | All subjects participated, randomly, in a 4 Hz transcutaneous electrical nerve stimulation session, a 110 Hz transcutaneous electrical nerve stimulation session, and a control (off-transcutaneous electrical nerve stimulation) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period Receives: Device: transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of sympathetic skin response
Sympathetic skin response from the simulated (Right) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.
Measured: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
Secondary outcomes (1)
Changes of skin temperature
skin temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
Measured: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of TENS on Sympathetic Skin ResponseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samaneh ebrahimi, Shiraz University of Medical Sciences
- Investigators
- Farzaneh Dehghan, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696149
- Sponsor's protocol ID
- 87-4520
- Status last verified
- Sep 2012
- First submitted
- 18 Sep 2012
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High and Low Frequency Transcutaneous Electrical Nerve Stimulation on Sympathetic Skin Response and Skin Temperature
- ClinicalTrials.gov ID
- NCT01696149
- Acronym / sponsor ID
- 87-4520
- Keywords
- TENS, sympathetic skin response, skin temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Sep 2012 (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 aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic skin response (SSR) and skin temperature.
Detailed description
15 healthy subjects (8 females, 7 males) with a mean age of 22.6 ± 3.7 years participated in this study.
All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.
Outcome measures: Sympathetic skin response from the simulated (Right) hand and skin temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrical nerve stimulation | Experimental | Device: transcutaneous electrical nerve stimulationAll subjects participated, randomly, in a 4 Hz transcutaneous electrical nerve stimulation session, a 110 Hz transcutaneous electrical nerve stimulation session, and a control (off-transcutaneous electrical nerve stimulation) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women aged 18 to 30 years
Key exclusion criteria (2 listed)
- History of cardiovascular, neurologic or musculoskeletal disease
- Taking medication at the time of the study
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 |
|---|---|---|
| transcutaneous electrical nerve stimulationAlso: TENSAll subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period. | Device | electrical nerve stimulation |
Primary outcome
Changes of sympathetic skin response
Time frame: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
Sympathetic skin response from the simulated (Right) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.
1 secondary outcome
Changes of skin temperature
Time frame: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
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 28 Sep 2012.
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.
Farzaneh Dehghan principal investigator
Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation in people with Effects of TENS on Sympathetic Skin Response, run by Shiraz University of Medical Sciences.
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 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes of sympathetic skin response (time frame: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions). 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 28 Sep 2012.