- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05586893
Acupuncture and Skin Temperature Behavior
October 18, 2022 updated by: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both sexes;
- Aged between 18-30 years;
- Good general health;
Exclusion Criteria:
- Pregnant women;
- Hemophiliacs;
- Smokers;
- Patients with severe cardiovascular diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Electroacupuncture
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.
|
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.
|
|
Experimental: Acupuncture therapy
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.
|
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.
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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].
|
30 minutes after the first assessment (P30)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
June 28, 2022
First Submitted That Met QC Criteria
October 18, 2022
First Posted (Actual)
October 19, 2022
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 18, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HCFMRP/USP 1332694/2015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.