An inert and active control acupuncture needle with potential for randomised, double-blind (practitioner-patient blinding), placebo controlled trial - a validation study

ISRCTN	ISRCTN34405634
DOI	https://doi.org/10.1186/ISRCTN34405634
Secondary identifying numbers	N/A

Submission date: 28/08/2009
Registration date: 11/09/2009
Last edited: 11/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

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

Prof Nobuari Takakura
Scientific

2-9-1 Ariake Koto-ku
Tokyo
135-0063
Japan

Phone	+81 3 6703 7016
Email	takakura@t-ariake.ac.jp

Study information

Study design	Randomised double-blind placebo-controlled single-centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	The double-blind placebo needle could be effective in a randomised clinical acupuncture trial in which multiple placebo needles are administered as treatment.
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 with stiff neck
Intervention	Mean age: 32.1 ± 9.9 years, 31 males, 25 females Aim: To assess whether the double-blind placebo needle is effective in a randomised clinical acupuncture trial in which multiple placebo needles are administered as treatment. Interventions: Non-penetrating control needles which the needle tip did not reach the skin (control), non-penetrating placebo needles which the needle tip pressed against the skin (placebo) and the penetrating (verum) needles. In this trial, each of 6 acupuncturists (mean +/- SD year: 12.5 ± 11.8 years) applied acupuncture treatment to 20 patients. For each treatment, the acupuncturist applied 4 needles to the subject's shoulder. After completion of treatment with 4 needles, the practitioner and subject were asked to record whether the treatment was "non-penetrating control," "non-penetrating placebo", "penetrating", or "unidentifiable." After the treatment, the subjects were asked on their improvement in intensity of stiff neck on a Visual Analogue Scale (VAS) ranging from -100 (the most intense stiff neck in the past) to 0 (no improvement) to 100 (no stiff neck). One treatment and no follow-up.
Intervention type	Other
Primary outcome measure	Numbers of correctly, incorrectly and unidentified treatments by practitioners and subjects.
Secondary outcome measures	Improvement of stiff neck on a VAS (0-100) immediately after treatment.
Overall study start date	26/01/2009
Completion date	24/02/2009

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Both
Target number of participants	120
Key inclusion criteria	1. Both males and females 2. Healthy volunteers 3. Age range: 18-70 years
Key exclusion criteria	Unhealthy volunteers
Date of first enrolment	26/01/2009
Date of final enrolment	24/02/2009

Locations

Countries of recruitment

Japan

Study participating centre

2-9-1 Ariake Koto-ku

Tokyo
135-0063
Japan

Sponsor information

Hanada College (Japan)
University/education

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

Phone	+81 3 3461 4787
Email	m-hanada@hanada.ac.jp
Website	http://www.hanada.ac.jp/
"ROR"	https://ror.org/0373a6k33

Funders

Funder type

University/education

Hanada College (Japan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan