NCT01948375

A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle

Effect of Blinding With a New Pragmatic Placebo Needle: a Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed description

blinding refers to subject blinding

Conditions

• Device Ineffective

Interventions

Type	Name	Description
DEVICE	real needle- placebo needle	All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.
DEVICE	placebo needle - real needle	All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-09-23
• Last updated: 2018-01-09
• Results posted: 2014-07-08

Locations

1 site across 1 country: China