Double-blind (practitioner-patient masking) trial of acupuncture needles: does patient reaction reveal needle authenticity?
| ISRCTN | ISRCTN81864187 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81864187 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/05/2008
- Registration date
- 03/07/2008
- Last edited
- 03/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Study information
| Study design | Double-blind, placebo-controlled, single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Research for effects of acupuncture stimulation on somatosensory function and somatic nerve reflex |
| Study objectives | In our previous study (http://www.ncbi.nlm.nih.gov/pubmed/17925042) we demonstrated that the penetrating and non-penetrating needles that we have developed can successfully be used to conduct a practitioner-blinded acupuncture trial. However, it is possible that the penetrating needle occasionally elicits pain in the patient, and the reaction of the patient can reveal the authenticity of the needle to the practitioner. In the current study, we aimed to determine the frequency in which the pain elicited by the penetrating needle and the reaction of the patient reveal authenticity of the needle to the practitioner. |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of Showa University, School of Medicine on the 24th December 1999 (ref: 65). |
| Health condition(s) or problem(s) studied | Healthy subjects |
| Intervention | 24 men and 6 women were recruited, mean (SD) age = 31.0 (9.8) years. This study was conducted to determine the frequency in which the penetrating needle elicits pain in the participant, and whether the participant reaction to the pain serves as a significant clue in revealing the authenticity of the needle in a practitioner-blinded acupuncture trial. In this trial, although only penetrating needles were actually provided, the acupuncturist was told that he was provided with a mixture of penetrating and non-penetrating needles. The acupuncturist then applied a pair of needles at the bilateral TE-5 points, one needle on each side, in the 30 subjects using the alternating twirling technique. Following each needle application, the acupuncturist recorded whether he thought the needle was a penetrating or non-penetrating needle, and the clues that led him to his decision (e.g., the participant's facial expression, body movement, verbal expression) and the level of confidence in his decision. |
| Intervention type | Other |
| Primary outcome measure | The practitoner recorded the following after each needle application: 1. Clues that led to acupuncturist's identification of authenticity of the needle, these included facial expression, body movement, verbal expression, bleeding, and no bleeding, in addition to the feeling of needle insertion and feeling of needle removal. 2. Acupuncturist's confidence in identification of needle authenticity (i.e., the degree of certainty about his judgment) on a numerical rating scale (0 for no confidence and 100 for complete confidence) |
| Secondary outcome measures | Subjects' identification of the authenticity of the needles. |
| Overall study start date | 01/09/2002 |
| Completion date | 25/12/2002 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Both males and females 2. Healthy volunteers 3. Age range: 18 - 55 years |
| Key exclusion criteria | Unhealthy volunteers |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 25/12/2002 |
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 |
|---|---|
| m-hanada@hanada.ac.jp | |
| Website | http://www.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 |
