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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Device Ineffective

Treatments: Device: real needle- placebo needle; Device: placebo needle - real needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01948375

2012BAI24B01-0

Details and patient eligibility

About

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.

Full description

blinding refers to subject blinding

Enrollment: 60 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

real needle- placebo needle

Experimental group

Description:

Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.

Treatment:

Device: real needle- placebo needle

placebo needle - real needle

Experimental group

Description:

Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.

Treatment:

Device: placebo needle - real needle