Acupuncture and Skin Temperature Behavior

NCT ID: NCT05586893

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-01-31

Brief 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.

Conditions

Thermography; Acupuncture Therapy; Electroacupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acupuncture therapy and Electroacupuncture

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Acupuncture therapy and Electroacupuncture

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Both sexes;
• Aged between 18-30 years;
• Good general health;

Exclusion Criteria

• Pregnant women;
• Hemophiliacs;
• Smokers;
• Patients with severe cardiovascular diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Elaine Caldeira de Oliveira Guirro

PhD Elaine Caldeiro de Oliveira Guirro - Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HCFMRP/USP 1332694/2015

Identifier Type: -

Identifier Source: org_study_id