Healthy ParticipantsNCT04073277
Acupuncture Needle Modified With Supercritical Fluid
A study testing SCF-N-treated needles and Untreated needles in people with Healthy Participants, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SCF-N-treated needles and Untreated needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer aged 20 to 40 years
- Provided informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- SCF-N-treated needles, Untreated needles
- Keywords
- Acupuncture needle, Supercritical fluid, De-qi, Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCF-N-treated needlesDevice
The SCF-N-treated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the experimental groups..
Untreated needlesDevice
he untreated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the control groups.
| Study group | Role | What they receive |
|---|---|---|
| SCF-N-treated needle acupuncture | Experimental | For each participant, one hand was randomly assigned to the experimental group with SCF-N-treated needle acupuncture . Receives: 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. Receives: Device: Untreated needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after acupuncture needling
Secondary outcomes (1)
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.
Measured: immediately after acupuncture needling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Aug 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073277
- Sponsor's protocol ID
- CMRPG8G0331
- Status last verified
- Jul 2018
- First submitted
- 26 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Improving Acupuncture Needles and Physical Properties of Acupoints With Supercritical Fluid
- ClinicalTrials.gov ID
- NCT04073277
- Acronym / sponsor ID
- CMRPG8G0331
- Conditions
- Healthy Participants
- Keywords
- Acupuncture needle, Supercritical fluid, De-qi, Chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SCF-N-treated needle acupuncture | Experimental | Device: SCF-N-treated needlesFor each participant, one hand was randomly assigned to the experimental group with SCF-N-treated needle acupuncture . |
| untreated needle acupuncture | Sham comparator | Device: Untreated needlesThe other hand of participant in experimental group was assigned to the control group with untreated needle acupuncture. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteer aged 20 to 40 years
- Provided informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCF-N-treated needlesThe SCF-N-treated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the experimental groups.. | Device | SCF-N-treated needle acupuncture |
| Untreated needleshe untreated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the control groups. | Device | untreated needle acupuncture |
Primary outcome
Resistance of the meridian
Time frame: immediately after acupuncture needling
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.
1 secondary outcome
Modified Visual Analog Scale (VAS) Score
Time frame: immediately after acupuncture needling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCF-N-treated needles and Untreated needles in people with Healthy Participants, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resistance of the meridian (time frame: immediately after acupuncture needling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.