Contact information
Type
Scientific
Primary contact
Prof Nobuari Takakura
ORCID ID
Contact details
2-9-1 Ariake Koto-ku
Tokyo
135-0063
Japan
+81 3 6703 7016
takakura@t-ariake.ac.jp
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the Ethics Committee of Showa University, School of Medicine on the 24th December 1999 (ref: 65).
Study design
Randomised double-blind placebo-controlled single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
26/01/2009
Overall trial end date
24/02/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females
2. Healthy volunteers
3. Age range: 18-70 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
Unhealthy volunteers
Recruitment start date
26/01/2009
Recruitment end date
24/02/2009
Locations
Countries of recruitment
Japan
Trial participating centre
2-9-1 Ariake Koto-ku
Tokyo
135-0063
Japan
Sponsor information
Organisation
Hanada College (Japan)
Sponsor details
20-1 Sakuragaoka-machi Shibuya-ku
Tokyo
150-0031
Japan
+81 3 3461 4787
m-hanada@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