Needle penetration versus placebo device: Double-Blind Acupuncture trial
| ISRCTN | ISRCTN50179298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50179298 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/12/2006
- Registration date
- 26/01/2007
- Last edited
- 12/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Scientific
20-1 Sakuragaoka-Machi
Shibuya-ku
Tokyo
150-0031
Japan
| Phone | +81 (0)3 3461 4787 |
|---|---|
| takakura@hanada.ac.jp |
Study information
| Study design | A crossover design with real-acupuncture and placebo-acupuncture. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Amount of pain eliciting painful electrical stimulation on a Visual Analogue Scale (VAS). |
| Secondary outcome measures | Intensity of needle sensations on a VAS. |
| Overall study start date | 01/07/2000 |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Japan
Study participating centre
20-1 Sakuragaoka-Machi
Tokyo
150-0031
Japan
150-0031
Japan
Sponsor information
Hanada College (Japan)
University/education
University/education
20-1 Sakuragaoka-Machi
Shibuya-ku
Tokyo
150-0031
Japan
| Phone | +81 (0)3 3461 4787 |
|---|---|
| takakura@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 |
