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HealthyNCT03157024

Validation of a Newly Developed Sham Press Needle

A study testing Real Needle (RN) in people with Healthy, run by Kyunghee University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single blind randomised controlled trial involving healthy volunteers to determine feasibility and blinding property of two types of sham press needles. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Real Needle (RN)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteSouth Korea
Study dates
4 Apr 2016to 2 Jun 2016
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age over 18
  • not participating in other clinical studies at the time of study participation
  • voluntary participation

Who cannot join

  • not satisfying the inclusion criteria
  • pregnancy or breast-feeding at the time of study participation
  • open sores or skin diseases on the non-dominant elbow or ear where needles would be placed
  • having taken analgesics in 24 hours before participation
  • any other diseases or conditions that might prevent the participant from receiving acupuncture

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Acupuncture & Meridian Science Research Centre, Kyung Hee University

    Seoul, 02447

Other trials in South Korea

About this study

This is a single blind randomised controlled trial involving healthy volunteers to determine feasibility and blinding property of two types of sham press needles.

Read the detailed description

A total of 84 healthy volunteers will be recruited and randomly allocated to receive real needles (RN), previously validated Kim Sham needles (KS), or newly developed Ring Sham needles (RS) at a 1:1:1 ratio. Acupuncture sensation, blinding, and feasibility in a future clinical trial will be measured along with other physiological measurements including tactile sensitivity, interoceptive sensitivity, and electrodermal activity.

Conditions
Healthy
Being tested
Ring Sham (RS), Real Needle (RN), Kim Sham (KS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ring Sham (RS)Device

  • Real Needle (RN)Device

  • Kim Sham (KS)Device

Study groups in NCT03157024
Study groupRoleWhat they receive
Sham Press Needle - Ring Sham (RS)ExperimentalA sterilised stainless steel press needle that only has the ring-shaped head of needle without needle body has three layers of adhesive tape. Between the first and second layer is the head of needle to support needle body while maintaining identical appearance and the third layer is attached to skin. RS will be placed on 1 cm medial to acupoint LI11 and ear wrist, a non-specific control auricular acupoint used in the previous literature of the non-dominant side. An acupoint detector (personal TENS electronic acupuncture, Hammtek Korea, Seoul, Korea) will be used to locate points with lower skin impedance than those nearby.
Receives: Device: Ring Sham (RS)
Real Needle (RN)Active comparatorA sterilised stainless steel press needle (diameter 0.18 mm X length 1.5 mm, Dongbang Acupuncture Inc., Boryeong, Chungcheongnam-do, Korea) has three layers of adhesive tape. Between the first and second layer is the head of needle to support needle body and the third layer is attached to skin. RN will be placed on acupoint LI11 and ear shenmen of the non-dominant side. An acupoint detector (personal TENS electronic acupuncture, Hammtek Korea, Seoul, Korea) will be used to locate points with lower skin impedance than those nearby.
Receives: Device: Real Needle (RN)
Kim Sham (KS)Sham comparatorA sterilised stainless steel press needle (diameter 0.18 mm X length 1.5 mm, Dongbang Acupuncture Inc., Boryeong, Chungcheongnam-do, Korea) with a blunted tip has three layers of adhesive tape. Between the first and second layer is the head of needle to support needle body while maintaining identical appearance and the third layer is attached to skin. KS will be placed on 1 cm medial to acupoint LI11 and ear wrist, a non-specific control auricular acupoint used in the previous literature of the non-dominant side. An acupoint detector (personal TENS electronic acupuncture, Hammtek Korea, Seoul, Korea) will be used to locate points with lower skin impedance than those nearby.
Receives: Device: Kim Sham (KS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blinding property

    Blinding property will be evaluated: the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know.

    Measured: After needling on the 1st day visit

Secondary outcomes (4)

  1. Adhesive power

    It will be assessed whether sham press needle remains in place for at least 2 days (yes/no).

    Measured: On the next day visit (1 day after needling)

  2. Acupuncture sensation measured by De-qi questionnaire

    De-qi questionnaire (Kim et al.) will be used to evaluate acupuncture sensation.

    Measured: After needling on the 1st day visit

  3. Acupuncture sensation measured by De-qi questionnaire

    De-qi questionnaire (Kim et al.) will be used to evaluate acupuncture sensation.

    Measured: After needle removal on the next day visit (1 day after needling)

  4. Blinding property

    Blinding property will be evaluated: the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know.

    Measured: After needle removal on the next day visit (1 day after needling)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start4 Apr 2016
  3. Primary completion2 Jun 2016
  4. Study completion2 Jun 2016

Resources

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
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03157024
Sponsor's protocol ID
KHSIRB-16-009
Status last verified
May 2017
First submitted
15 May 2017
Last updated
17 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim S. Creating an instrument for a successful double-blind acupuncture placebo. J Acupunct Meridian Stud. 2008 Sep;1(1):36-41. doi: 10.1016/S2005-2901(09)60005-4. Epub 2009 Mar 24.

    PubMed 20633453

  • Lee H, Bang H, Kim Y, Park J, Lee S, Lee H, Park HJ. Non-penetrating sham needle, is it an adequate sham control in acupuncture research? Complement Ther Med. 2011 Jan;19 Suppl 1:S41-8. doi: 10.1016/j.ctim.2010.12.002. Epub 2010 Dec 23.

    PubMed 21195294

  • Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.

    PubMed 15020033

  • Moroz A, Freed B, Tiedemann L, Bang H, Howell M, Park JJ. Blinding measured: a systematic review of randomized controlled trials of acupuncture. Evid Based Complement Alternat Med. 2013;2013:708251. doi: 10.1155/2013/708251. Epub 2013 Mar 3.

    PubMed 23533515

  • Kim Y, Park J, Lee H, Bang H, Park HJ. Content validity of an acupuncture sensation questionnaire. J Altern Complement Med. 2008 Oct;14(8):957-63. doi: 10.1089/acm.2007.0565.

    PubMed 18925869

  • Kim S, Lee S, Choi S, Park J, Kim S. Discrimination accuracy between real and sham press needles in the hands. Acupunct Med. 2015 Aug;33(4):293-8. doi: 10.1136/acupmed-2014-010678. Epub 2015 Jun 4.

    PubMed 26044714

  • Wang SM, Maranets I, Weinberg ME, Caldwell-Andrews AA, Kain ZN. Parental auricular acupuncture as an adjunct for parental presence during induction of anesthesia. Anesthesiology. 2004 Jun;100(6):1399-404. doi: 10.1097/00000542-200406000-00011.

    PubMed 15166558

  • Wang SM, Dezinno P, Lin EC, Lin H, Yue JJ, Berman MR, Braveman F, Kain ZN. Auricular acupuncture as a treatment for pregnant women who have low back and posterior pelvic pain: a pilot study. Am J Obstet Gynecol. 2009 Sep;201(3):271.e1-9. doi: 10.1016/j.ajog.2009.04.028. Epub 2009 Jun 26.

    PubMed 19560110

  • Schandry R. Heart beat perception and emotional experience. Psychophysiology. 1981 Jul;18(4):483-8. doi: 10.1111/j.1469-8986.1981.tb02486.x. No abstract available.

    PubMed 7267933

  • Vincent C, Lewith G. Placebo controls for acupuncture studies. J R Soc Med. 1995 Apr;88(4):199-202.

    PubMed 7745565

Questions about this trial

What is this clinical trial studying?

A study testing Real Needle (RN) in people with Healthy, run by Kyunghee University at 1 site in South Korea.

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 3 inclusion and 5 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 17 May 2017. 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 South Korea. 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?

Blinding property (time frame: After needling on the 1st day visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03157024, which also lists 10 linked publications.

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 17 May 2017.

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