Acupuncture Needle Modified With Supercritical Fluid

Study on Improving Acupuncture Needles and Physical Properties of Acupoints With Supercritical Fluid

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Device: SCF-N-treated needles; Device: Untreated needles

Detailed Description

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.

The acupuncture needles used in this experiment, including the SCF-N-treated needles and the control stainless steel needles, were produced under the same conditions, in the same factory (Dong Bang acupuncture Inc.), and on the same day, to minimize experimental error.

The process of SCF treatment:. First, the stainless steel chamber and quartz carrier were sterilized using alcohol and autoclaving. Next, the needles were placed on the quartz carrier with the tip pointing upwards and then placed in the chamber and covered. Carbon dioxide was used to remove atmospheric components from the chamber and required volume of ammonia gas was passed. The pressure was increased up to 3000 pound per square inch(psi) and temperature up to 120℃. An hour later, the pressure was relieved and the process of SCF treatment completed. After completion of the treatment, the needles were then randomly selected for material analysis and electrical measurement. Following this, the needles were stored in a vacuum bag. This was done to reduce the influence of atmospheric contaminants on the needles after treatment, resulting in oxidation and rusting. Finally, there would be heterogeneous contact between the inorganic metal and the acupuncture needle. Hence, nitrogen was selected as the main agent for SCF treatment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCF-N-treated needle acupuncture; For each participant, one hand was randomly assigned to the experimental group with SCF-N-treated needle acupuncture .	Device: SCF-N-treated needles; The SCF-N-treated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the experimental groups..
Sham Comparator: untreated needle acupuncture; The other hand of participant in experimental group was assigned to the control group with untreated needle acupuncture.	Device: Untreated needles; he untreated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the control groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Visual Analog Scale (VAS) Score	The VAS score was used to assess the needling sensations of de-qi, i.e. distension, soreness, heaviness, or numbness. VAS score 0 indicated no sensation, while VAS 10 indicated the strongest sensation.	immediately after acupuncture needling

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Chinese medicine; Acupuncture needle; Supercritical fluid; De-qi
• Other Study ID Numbers: CMRPG8G0331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No