Condition category
Not Applicable
Date applied
15/05/2008
Date assigned
03/07/2008
Last edited
03/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nobuari Takakura

ORCID ID

Contact details

20-1 Sakuragaoka-Machi
Shibuya-ku
Tokyo
150-0031
Japan

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 measures

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

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

http://www.hanada.ac.jp

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes