Acupuncture Needle Modified With Supercritical Fluid
Condition: Healthy Participants
Study type: Interventional

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.
    

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.
    

Intervention name(s): SCF-N-treated needles; Untreated needles
Intervention type(s): Device; Device
Intervention description(s): The SCF-N-treated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the experimental groups..; he untreated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the control groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model 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.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture needle; Supercritical fluid; De-qi; Chinese medicine