ClinicalTrials.Veeva

Menu

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

G

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems