N/A
N=60
A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle
Device Ineffective
Bottom Line
View on ClinicalTrials.gov: NCT01948375 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. — 1; 0; 29; 30 participants — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- real needle- placebo needle (Device); placebo needle - real needle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. |
1; 0; 29; 30; 0; 0 | >0.05 |
| SECONDARY Southampton Needle Sensation Questionnaire-Type of Needle Sensation |
8; 6; 20; 17; 2; 7 | — |
| SECONDARY Southampton Needle Sensation Questionnaire-Degree of Needle Sensation |
1; 3; 14; 17; 15; 9 | 0.007 sig |
| SECONDARY Degree of Acupuncture Pain |
3.02; 2.73; 3.70; 3.46 | =0.006 sig |
| SECONDARY Acceptability of the Acupuncture Needle |
0; 0; 0; 1; 15; 11 | =0.048 sig |
Summary
Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have applied a new kind of placebo needle in large scale acupuncture clinical trials, which named as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials, this pragmatic placebo needle shows several advantages: the outlook closer to traditional acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and more economical. However, its blinding effect is not yet validated. The primary objective of this trial is to validate the blinding effect of the new pragmatic placebo needle; the secondary objective is to explore factors influencing the blinding effect of the placebo needles.
Eligibility Criteria
Inclusion Criteria
- 18-74 years old;
- with a basic capacity of listening, speaking, reading and writing in Chinese;
- volunteer to join this research and sign the informed consent.
Exclusion Criteria
- with acute or chronic pain;
- taking analgesics or drugs inducing abnormal sensation;
- with diseases of sensory disturbance or sensory loss;
- with alcohol or drug abuse history;
- serious cardiovascular, cerebral, hepatic, renal, hematopoietic, hemorrhagic or psychiatric diseases;
- diabetes mellitus or dermatological disease;
- women in pregnancy or lactation period;
- cardiac pacemaker carrier, metal allergy or severe needle phobia.
Data sourced from ClinicalTrials.gov (NCT01948375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.