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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05586893
Other study ID # HCFMRP/USP 1332694/2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date January 2017

Study information

Verified date October 2022
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date January 2017
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Both sexes; - Aged between 18-30 years; - Good general health; Exclusion Criteria: - Pregnant women; - Hemophiliacs; - Smokers; - Patients with severe cardiovascular diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Acupuncture therapy and Electroacupuncture
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary 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]. 30 minutes after the first assessment (P30)
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