Needle penetration versus placebo device: Double-Blind Acupuncture trial

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

Dr Nobuari Takakura
Scientific

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

Phone	+81 (0)3 3461 4787
Email	takakura@hanada.ac.jp

Primary study design	Interventional
Study design	A crossover design with real-acupuncture and placebo-acupuncture.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DBAS
Study objectives	Needle penetration of acupuncture has specific analgesic effect over placebo acupuncture.
Ethics approval(s)	Approval received from The Showa University Ethics Committee on the 24 December 1999 (ref: 65).
Health condition(s) or problem(s) studied	Healthy volunteers, no disease
Intervention	A placebo needle, which cannot penetrate the skin, and a real needle, which can penetrate the skin.
Intervention type	Device
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Amount of pain eliciting painful electrical stimulation on a Visual Analogue Scale (VAS).
Key secondary outcome measure(s)	Intensity of needle sensations on a VAS.
Completion date	01/07/2005

Participant type(s)	Healthy volunteer
Age group	Not Specified
Sex	All
Target sample size at registration	50
Key inclusion criteria	Healthy volunteers familiar with acupuncture treatment.
Key exclusion criteria	1. Unhealty volunteers 2. Healthy volunteers unfamiliar with acupuncture treatment
Date of first enrolment	01/07/2000
Date of final enrolment	01/07/2005

20-1 Sakuragaoka-Machi

Tokyo
150-0031
Japan

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