Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Research for effects of acupuncture stimulation on somatosensory function and somatic nerve reflex
Acronym
Study hypothesis
In our previous study (http://www.ncbi.nlm.nih.gov/pubmed/17925042) we demonstrated that the penetrating and non-penetrating needles that we have developed can successfully be used to conduct a practitioner-blinded acupuncture trial. However, it is possible that the penetrating needle occasionally elicits pain in the patient, and the reaction of the patient can reveal the authenticity of the needle to the practitioner. In the current study, we aimed to determine the frequency in which the pain elicited by the penetrating needle and the reaction of the patient reveal authenticity of the needle to the practitioner.
Ethics approval
Ethics approval received from the Ethics Committee of Showa University, School of Medicine on the 24th December 1999 (ref: 65).
Study design
Double-blind, placebo-controlled, single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Healthy subjects
Intervention
24 men and 6 women were recruited, mean (SD) age = 31.0 (9.8) years.
This study was conducted to determine the frequency in which the penetrating needle elicits pain in the participant, and whether the participant reaction to the pain serves as a significant clue in revealing the authenticity of the needle in a practitioner-blinded acupuncture trial.
In this trial, although only penetrating needles were actually provided, the acupuncturist was told that he was provided with a mixture of penetrating and non-penetrating needles. The acupuncturist then applied a pair of needles at the bilateral TE-5 points, one needle on each side, in the 30 subjects using the alternating twirling technique. Following each needle application, the acupuncturist recorded whether he thought the needle was a penetrating or non-penetrating needle, and the clues that led him to his decision (e.g., the participant's facial expression, body movement, verbal expression) and the level of confidence in his decision.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The practitoner recorded the following after each needle application:
1. Clues that led to acupuncturist's identification of authenticity of the needle, these included facial expression, body movement, verbal expression, bleeding, and no bleeding, in addition to the feeling of needle insertion and feeling of needle removal.
2. Acupuncturist's confidence in identification of needle authenticity (i.e., the degree of certainty about his judgment) on a numerical rating scale (0 for no confidence and 100 for complete confidence)
Secondary outcome measures
Subjects' identification of the authenticity of the needles.
Overall trial start date
01/09/2002
Overall trial end date
25/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females
2. Healthy volunteers
3. Age range: 18 - 55 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
Unhealthy volunteers
Recruitment start date
01/09/2002
Recruitment end date
25/12/2002
Locations
Countries of recruitment
Japan
Trial participating centre
20-1 Sakuragaoka-Machi
Tokyo
150-0031
Japan
Sponsor information
Organisation
Hanada College (Japan)
Sponsor details
20-1 Sakuragaoka-Machi
Shibuya-ku
Tokyo
150-0031
Japan
+81 (0)3 3461 4787
m-hanada@hanada.ac.jp
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Hanada College (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list