Acupuncture Needle Modified With Supercritical Fluid

NCT04073277 | Completed

• 1 other identifier: CMRPG8G0331
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare the differences in the needling sensation with acupuncture needles surface treated with nitrogen applied supercritical fluid (SCF-N) and stainless steel needles. Materials and Methods: This was a double-blind prospective cohort study. The acupuncture needles were randomly used in this experiment, including the SCF-N-treated needles and the control stainless steel needles. LI 4 (Hegu) and LI 11 (Quchi) acupuncture points in the Yangming Large Intestine Meridian of Hand were treated. Physical electrical resistance , scanning electron microscopy, energy dispersive spectrometry, and visual analog scale score including the sensations of soreness, numbness, distention, and heaviness were assessed.

Conditions

Healthy Participants

Keywords

Acupuncture needle; Supercritical fluid; De-qi; Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Resistance of the meridian

  Electrical resistance was measured by applying a fixed electric current (110 µA) for 1 second and recording the I-V curve. A linear relationship of voltage=current x resistance was expected. The analyzer used in this experiment was Agilent B1500, a semi-conductor analyzer able to measure electrical resistance with high accuracy.

  immediately after acupuncture needling

Secondary Outcomes (1)

• Modified Visual Analog Scale (VAS) Score

  immediately after acupuncture needling

Study Arms (2)

SCF-N-treated needle acupuncture

EXPERIMENTAL

For each participant, one hand was randomly assigned to the experimental group with SCF-N-treated needle acupuncture .

Device: SCF-N-treated needles

untreated needle acupuncture

SHAM COMPARATOR

The other hand of participant in experimental group was assigned to the control group with untreated needle acupuncture.

Device: Untreated needles

Interventions

SCF-N-treated needles DEVICE

The SCF-N-treated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the experimental groups..

SCF-N-treated needle acupuncture

Untreated needles DEVICE

he untreated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the control groups.

untreated needle acupuncture

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer aged 20 to 40 years
• Provided informed consent

You may not qualify if:

• Women with pregnancy or breast feeding
• Bleeding tendencies (platelet counts less than 20000 and/or thrombocytopenic purpura)
• Volunteers with chronic medical conditions and anti-coagulants use
• Volunteers with pacemakers
• Fasting
• Unwilling to provide informed consent

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The gross appearance of the two groups of needles were the same. They could be identified under microscope only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a double-blinded prospective cohort study. The acupuncture needles were first separated into two groups. One group of needles was subjected to SCF-N treatment while the other was not. The needles were then randomly analyzed with scanning electron microscope and energy dispersive X-ray spectroscopy to ensure quality and minimize experimental error. For each participant, one hand was randomly assigned to the treatment group with SCF-N-treated acupuncture needles and the other hand was assigned to the control group with the stainless steel needles. The time interval between the acupuncture treatment of the two groups was about two hours. In order to examine and distinguish the difference between the two groups, de-qi VAS score was recorded by the volunteers during needle insertion and the electrical resistance by electrical measurement.

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 29, 2019
• Study Start: August 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 29, 2019

Record last verified: 2018-07

Locations

TW (1)