Double-blind (practitioner-patient masking) trial of acupuncture needles: does patient reaction reveal needle authenticity?

ISRCTN	ISRCTN81864187
DOI	https://doi.org/10.1186/ISRCTN81864187
Protocol serial number	N/A
Sponsor	Hanada College (Japan)
Funder	Hanada College (Japan)

Submission date: 15/05/2008
Registration date: 03/07/2008
Last edited: 03/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nobuari Takakura
Scientific

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

Study information

Primary study design	Interventional
Study design	Double-blind, placebo-controlled, single-centre study
Secondary study design	Randomised controlled trial
Scientific title	Research for effects of acupuncture stimulation on somatosensory function and somatic nerve reflex
Study objectives	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(s)	Ethics approval received from the Ethics Committee of Showa University, School of Medicine on the 24th December 1999 (ref: 65).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	Subjects' identification of the authenticity of the needles.
Completion date	25/12/2002

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Both males and females 2. Healthy volunteers 3. Age range: 18 - 55 years
Key exclusion criteria	Unhealthy volunteers
Date of first enrolment	01/09/2002
Date of final enrolment	25/12/2002

Locations

Countries of recruitment

Japan

Study participating centre

20-1 Sakuragaoka-Machi

Tokyo
150-0031
Japan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan