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OpenTrials
Completed

NCT Number: NCT03157024

Validation of a Newly Developed Sham Press Needle

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

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acupuncture & Meridian Science Research Centre, Kyung Hee University

Seoul, 02447, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ring Sham (RS)

Device

Real Needle (RN)

Device

Kim Sham (KS)

Device

Primary outcomes

  1. Blinding property

    Time frame: After needling on the 1st day visit

    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.

Secondary outcomes

  1. Adhesive power

    Time frame: On the next day visit (1 day after needling)

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

  2. Acupuncture sensation measured by De-qi questionnaire

    Time frame: After needling on the 1st day visit

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

  3. Acupuncture sensation measured by De-qi questionnaire

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

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

  4. Blinding property

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

    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.

Other outcomes

  1. Acupuncture Belief Scale (ABS)

    Time frame: After needling on the 1st day visit

    A Korean version of Acupuncture Belief Scale (ABS), a 36-item self-report on a 5-point Likert scale will be used to evaluate acupuncture experiences and beliefs.

  2. Tactile sensitivity

    Time frame: On the 1st day visit

    Tactile sensitivity will be measured using von Frey filament.

  3. Interoceptive sensitivity

    Time frame: On the 1st day visit

    Using a modified method by Schandry, the participants will be asked to count their own heartbeats with eyes closed during the three counting phases that vary in length randomly, i.e. 25, 35, and 45 seconds. Beginning and end of a phase will be given verbally by the experimenter. Information on the length of the three counting phases will not be open to participants. Heart rate will also be recorded and analysed by a computer-based data acquisition system (MP150 data acquisition system, version 4.3.0, Biopac® Systems, Inc., Goleta, CA, USA).

  4. Electrodermal activity (EDA)

    Time frame: On the 1st day visit

    EDA data will be obtained to evaluate autonomic response following acupuncture needling (MP150 data acquisition system, version 4.3.0, Biopac® Systems, Inc., Goleta, CA, USA).

  5. Acupuncture credibility

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

    Credibility of the acupuncture treatment will be evaluated using a credibility test by Vincent et al.

Sponsors and collaborators

Lead sponsor

Kyunghee University

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 17, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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