Cold ExposurePhase 1/2NCT01483885
Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain
A Phase 1/2 study testing Transcutaneous Electric Nerve Stimulation, Interferential Current and Manual Acupuncture in people with Cold Exposure, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
Physiotherapy offers a range of therapeutic modalities for pain management including Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS, CI and Acupuncture in a cold-induced pain model. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Exposure
- What is being tested?
- Transcutaneous Electric Nerve Stimulation, Interferential Current and Manual Acupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Oct 2011
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
Who cannot join
- Subjects with no history of any kind of disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain.
Physiotherapy offers a range of therapeutic modalities for pain management including Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS, CI and Acupuncture in a cold-induced pain model.
- Conditions
- Cold Exposure
- Being tested
- Transcutaneous Electric Nerve Stimulation, Interferential Current, Manual Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electric Nerve StimulationDevice
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
Interferential CurrentDevice
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
Manual AcupunctureProcedure or surgery
Manual acupuncture will be delivered with sterile needles for each subject in the acupoint TA5 and CS6 localized in the dominant forearm.
| Study group | Role | What they receive |
|---|---|---|
| TENS 4Hz | Experimental | Not described Receives: Device: Transcutaneous Electric Nerve Stimulation |
| Interferential Current 4Hz | Experimental | Not described Receives: Device: Interferential Current |
| TENS | Placebo comparator | Not described Receives: Device: Transcutaneous Electric Nerve Stimulation |
| Interferential Current | Placebo comparator | Not described Receives: Device: Interferential Current |
| Manual Acupuncture | Experimental | Not described Receives: Procedure: Manual Acupuncture |
| TENS 100 Hz | Experimental | Not described Receives: Device: Transcutaneous Electric Nerve Stimulation |
| Interferential Current 100Hz | Experimental | Not described Receives: Device: Interferential Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold Pain threshold
Cold pain threshold is recorded as the time from immersing the hand in the cold water to pain using a digital timer.
Measured: 24 hours
Secondary outcomes (1)
Pain Tolerance threshold
Cold Tolerance threshodl is recorded as the time from immersing the hand in the cold water to maximal pain tolerance using a digital timer.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold ExposureStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuad Ahmad Hazime, Universidade Federal do Piauí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483885
- Sponsor's protocol ID
- 0208.0.045.000-11
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain.
- ClinicalTrials.gov ID
- NCT01483885
- Acronym / sponsor ID
- 0208.0.045.000-11
- Conditions
- Cold Exposure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Dec 2011 (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.
Physiotherapy offers a range of therapeutic modalities for pain management including Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS, CI and Acupuncture in a cold-induced pain model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| TENS 4Hz | Experimental | Device: Transcutaneous Electric Nerve Stimulation |
| Interferential Current 4Hz | Experimental | Device: Interferential Current |
| TENS | Placebo comparator | Device: Transcutaneous Electric Nerve Stimulation |
| Interferential Current | Placebo comparator | Device: Interferential Current |
| Manual Acupuncture | Experimental | Procedure: Manual Acupuncture |
| TENS 100 Hz | Experimental | Device: Transcutaneous Electric Nerve Stimulation |
| Interferential Current 100Hz | Experimental | Device: Interferential Current |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (1 listed)
- Subjects with no history of any kind of disease
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 Electric Nerve StimulationTens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil) | Device | TENS, TENS 100 Hz, TENS 4Hz |
| Interferential CurrentInterferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil) | Device | Interferential Current, Interferential Current 100Hz, Interferential Current 4Hz |
| Manual AcupunctureManual acupuncture will be delivered with sterile needles for each subject in the acupoint TA5 and CS6 localized in the dominant forearm. | Procedure or surgery | Manual Acupuncture |
Primary outcome
Cold Pain threshold
Time frame: 24 hours
Cold pain threshold is recorded as the time from immersing the hand in the cold water to pain using a digital timer.
1 secondary outcome
Pain Tolerance threshold
Time frame: 24 hours
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 2 Dec 2011.
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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 Phase 1/2 study testing Transcutaneous Electric Nerve Stimulation, Interferential Current and Manual Acupuncture in people with Cold Exposure, run by Universidade Federal do Piauí 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 2 Dec 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cold Pain threshold (time frame: 24 hours). 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 2 Dec 2011.