ThermographyNCT05586893
Acupuncture and Skin Temperature Behavior
A study testing Acupuncture therapy and Electroacupuncture in people with Thermography and Acupuncture Therapy, run by University of Sao Paulo.
Trial summary
Objective: Evaluating the behavior of skin temperature through infrared thermography after application of acupuncture and electroacupuncture in Weizhong (B40) and Kunlun (B60) acupunctures points. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Thermography, Acupuncture Therapy, Electroacupuncture
- What is being tested?
- Acupuncture therapy and Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2017
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both sexes;
- Aged between 18-30 years;
- Good general health;
Who cannot join
- Pregnant women;
- Hemophiliacs;
- Smokers;
- Patients with severe cardiovascular diseases.
About this study
Official title: Skin Temperature Behavior by Infrared Thermography After Application of Electroacupuncture and Acupuncture
Objective: Evaluating the behavior of skin temperature through infrared thermography after application of acupuncture and electroacupuncture in Weizhong (B40) and Kunlun (B60) acupunctures points. Methods: A single-blind randomized clinical trial was performed with 54 participants of both sexes, mean of 21.88±2.53 years, randomized into three groups (n=18): electroacupuncture (EAG), acupuncture (AG) and control (CG). The application was bilateral in the acupoints (B60 and B40), for 20 minutes. The skin temperature of the lower limbs was measured at the following times: before application, 10 minutes of application, 20 minutes of application and 10 minutes after needle removal.
- Conditions
- Thermography, Acupuncture Therapy, Electroacupuncture
- Being tested
- Acupuncture therapy and Electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture therapy and ElectroacupunctureDevice
We used the following Bladder acupuncture points, Weizong (B40) in the middle of the popliteal fossa and Kunlun (B60) located in a depression between the lateral malleolus and the Achilles tendon. The subjects were instructed to report the "De Qi" perception (paresthesia or numbness) that was the advice to the researchers that the point was right punctured. After the De qi was reported, the needle remained in the acupuncture point for 20 minutes and was rotated three times more for the preservation of the effect. During this time, all subjects remained in the supine laying down position on the stretcher.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | The acupuncture electrical stimulation was performed by the EL 608 electroacupuncture device (NKL, Brusque - SC, Brazil, ANVISA 80191680002). For the stimulation of the acupuncture points, we selected a biphasic wave, 2 HZ of frequency, 6 mA of wavelength, and 5 seconds at resting time. The total stimulation time was 20 minutes. Receives: Device: Acupuncture therapy and Electroacupuncture |
| Acupuncture therapy | Experimental | The acupuncture points were bilaterally punctured by a stainless steel acupuncture needle (length 30mm x diameter 0.25) (Dongbang, Boryeong, Chungnam- Korea). We used the following Bladder acupuncture points, Weizong (B40) in the middle of the popliteal fossa and Kunlun (B60) located in a depression between the lateral malleolus and the Achilles tendon. The subjects were instructed to report the "De Qi" perception (paresthesia or numbness) that was the advice to the researchers that the point was right punctured. After the De qi was reported, the needle remained in the acupuncture point for 20 minutes and was rotated three times more for the preservation of the effect. During this time, all subjects remained in the supine laying down position on the stretcher. Receives: Device: Acupuncture therapy and Electroacupuncture |
| Control Group | No intervention | Infrared images were captured at the first assessment (P0), 10 minutes later (P10), 20 minutes later (P20) and 30 minutes after the first assessment (P30). All analyzes were performed using QuickReport software, version 1.2 (FLIR Systems). No application of interventions between assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin temperature
Skin temperature was evaluated by infrared thermography using a thermal camera, brand FLIR® Systems (T300, Wilsonville, OR, USA), and accuracy of up to 0.05º C, with emissivity of 0.98 being established and the instrument stabilized for 10 minutes before the exam. Three infrared images were captured in sequence at a distance of 100 cm from the individual, in order to allow the framing of the evaluated limb [20].
Measured: 30 minutes after the first assessment (P30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermographyStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586893
- Sponsor's protocol ID
- HCFMRP/USP 1332694/2015
- Status last verified
- Oct 2022
- First submitted
- 28 Jun 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Temperature Behavior by Infrared Thermography After Application of Electroacupuncture and Acupuncture
- ClinicalTrials.gov ID
- NCT05586893
- Acronym / sponsor ID
- HCFMRP/USP 1332694/2015
- Conditions
- Thermography, Acupuncture Therapy, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Oct 2022 (actual)
- 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.
Objective: Evaluating the behavior of skin temperature through infrared thermography after application of acupuncture and electroacupuncture in Weizhong (B40) and Kunlun (B60) acupunctures points. Methods: A single-blind randomized clinical trial was performed with 54 participants of both sexes, mean of 21.88±2.53 years, randomized into three groups (n=18): electroacupuncture (EAG), acupuncture (AG) and control (CG). The application was bilateral in the acupoints (B60 and B40), for 20 minutes. The skin temperature of the lower limbs was measured at the following times: before application, 10 minutes of application, 20 minutes of application and 10 minutes after needle removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Device: Acupuncture therapy and ElectroacupunctureThe acupuncture electrical stimulation was performed by the EL 608 electroacupuncture device (NKL, Brusque - SC, Brazil, ANVISA 80191680002). For the stimulation of the acupuncture points, we selected a biphasic wave, 2 HZ of frequency, 6 mA of wavelength, and 5 seconds at resting time. The total stimulation time was 20 minutes. |
| Acupuncture therapy | Experimental | Device: Acupuncture therapy and ElectroacupunctureThe acupuncture points were bilaterally punctured by a stainless steel acupuncture needle (length 30mm x diameter 0.25) (Dongbang, Boryeong, Chungnam- Korea). We used the following Bladder acupuncture points, Weizong (B40) in the middle of the popliteal fossa and Kunlun (B60) located in a depression between the lateral malleolus and the Achilles tendon. The subjects were instructed to report the "De Qi" perception (paresthesia or numbness) that was the advice to the researchers that the point was right punctured. After the De qi was reported, the needle remained in the acupuncture point for 20 minutes and was rotated three times more for the preservation of the effect. During this time, all subjects remained in the supine laying down position on the stretcher. |
| Control Group | No intervention | –Infrared images were captured at the first assessment (P0), 10 minutes later (P10), 20 minutes later (P20) and 30 minutes after the first assessment (P30). All analyzes were performed using QuickReport software, version 1.2 (FLIR Systems). No application of interventions between assessments. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both sexes;
- Aged between 18-30 years;
- Good general health;
Key exclusion criteria (4 listed)
- Pregnant women;
- Hemophiliacs;
- Smokers;
- Patients with severe cardiovascular diseases.
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 |
|---|---|---|
| Acupuncture therapy and ElectroacupunctureWe used the following Bladder acupuncture points, Weizong (B40) in the middle of the popliteal fossa and Kunlun (B60) located in a depression between the lateral malleolus and the Achilles tendon. The subjects were instructed to report the "De Qi" perception (paresthesia or numbness) that was the advice to the researchers that the point was right punctured. After the De qi was reported, the needle remained in the acupuncture point for 20 minutes and was rotated three times more for the preservation of the effect. During this time, all subjects remained in the supine laying down position on the stretcher. | Device | Acupuncture therapy, Electroacupuncture |
Primary outcome
Skin temperature
Time frame: 30 minutes after the first assessment (P30)
Skin temperature was evaluated by infrared thermography using a thermal camera, brand FLIR® Systems (T300, Wilsonville, OR, USA), and accuracy of up to 0.05º C, with emissivity of 0.98 being established and the instrument stabilized for 10 minutes before the exam. Three infrared images were captured in sequence at a distance of 100 cm from the individual, in order to allow the framing of the evaluated limb [20].
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 19 Oct 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture therapy and Electroacupuncture in people with Thermography and Acupuncture Therapy, run by University of Sao Paulo.
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 3 inclusion and 4 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 19 Oct 2022. 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?
Skin temperature (time frame: 30 minutes after the first assessment (P30)). 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 19 Oct 2022.