Condition category
Musculoskeletal Diseases
Date applied
28/08/2009
Date assigned
11/09/2009
Last edited
11/09/2009
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

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

http://www.hanada.ac.jp/

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