Condition category
Signs and Symptoms
Date applied
08/12/2006
Date assigned
26/01/2007
Last edited
12/09/2011
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
+81 (0)3 3461 4787
takakura@hanada.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DBAS

Study hypothesis

Needle penetration of acupuncture has specific analgesic effect over placebo acupuncture.

Ethics approval

Approval received from The Showa University Ethics Committee on the 24 December 1999 (ref: 65).

Study design

A crossover design with real-acupuncture and placebo-acupuncture.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Primary outcome measures

Amount of pain eliciting painful electrical stimulation on a Visual Analogue Scale (VAS).

Secondary outcome measures

Intensity of needle sensations on a VAS.

Overall trial start date

01/07/2000

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers familiar with acupuncture treatment.

Participant type

Healthy volunteer

Age group

Not Specified

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Unhealty volunteers
2. Healthy volunteers unfamiliar with acupuncture treatment

Recruitment start date

01/07/2000

Recruitment end date

01/07/2005

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
takakura@hanada.ac.jp

Sponsor type

University/education

Website

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