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

NCT ID: NCT01948375

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

real needle- placebo needle

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

Group Type: EXPERIMENTAL

real needle- placebo needle

Intervention Type: DEVICE

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.

placebo needle - real needle

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

Group Type: EXPERIMENTAL

placebo needle - real needle

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhishun

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhishun Liu

Role: STUDY_DIRECTOR

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Locations

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2012BAI24B01-0

Identifier Type: -

Identifier Source: org_study_id