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

NCT01948375 | Completed Results DMC

• 1 other identifier: 2012BAI24B01-0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Ineffective

Keywords

subject blinding; placebo needle

Outcome Measures

Primary Outcomes (1)

• Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.

  The primary outcome was the proportion of volunteers'perception of needle penetration between the placebo needle and the real needle in the third acupuncture session in each period. LI4, on the dorsum of the hand, between the first and second metacarpal bones, approximately in the center of the second metacarpal bone; RN12, on the upper abdomen,4 cun above the umbilicus,on the anterior midline; BL36, on the back of the thigh,on the midpoint of the inferior gluteal crease; BL25, on the loin, 1.5 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra.

  in the third acupuncture session in each period

Secondary Outcomes (4)

• Southampton Needle Sensation Questionnaire-Type of Needle Sensation

  in the third acupuncture session in each period

• Southampton Needle Sensation Questionnaire-Degree of Needle Sensation

  in the third acupuncture session in each period

• Degree of Acupuncture Pain

  in the third acupuncture session in each period

• Acceptability of the Acupuncture Needle

  in the third acupuncture session in each period

Study Arms (2)

real needle- placebo needle

EXPERIMENTAL

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

Device: real needle- placebo needle

placebo needle - real needle

EXPERIMENTAL

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

Device: placebo needle - real needle

Interventions

real needle- placebo needle 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.

real needle- placebo needle

placebo needle - real needle 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

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• with a basic capacity of listening, speaking, reading and writing in Chinese;
• volunteer to join this research and sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100053, China

Location

Results Point of Contact

• Title: Zhishun Liu, Director of the study
• Organization: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

liuzhishun@aliyun.com.cn

8610-010-88001124

Study Officials

• Zhishun Liu

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 8, 2013
• First Posted: September 23, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 9, 2018
• Results First Posted: July 8, 2014

Record last verified: 2017-12

Locations

CN (1)