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

Device Ineffective Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948375
• Other study ID #: 2012BAI24B01-0
• Status: Completed
• Phase: N/A
• First received: September 8, 2013
• Last updated: December 23, 2017
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

blinding refers to subject blinding

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Device Ineffective

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Southampton Needle Sensation Questionnaire—Type of Needle Sensation	This questionnaire is used to collect the types and degree of needle sensation experienced by participants. Information is collected after the third acupuncture session in each period. The difference between two kinds of needles is to be analyzed.	in the third acupuncture session in each period
Secondary	Southampton Needle Sensation Questionnaire—Degree of Needle Sensation	The degree of needle sensation between the placebo needle and the real needle were compared.; The data of degree of needle sensation of the placebo needle included rows 1-4,i.e,, rows of "placebo needle:no", "placebo needle: mild", "placebo needle: moderate" and "placebo needle: severe".; The data of degree of needle sensation of the real needle included rows 5-8, i.e., rows of "real needle: no", 'real needle: mild", "real needle: moderate", and "real needle: severe".	in the third acupuncture session in each period
Secondary	Degree of Acupuncture Pain	The pain of acupuncture is assessed using visual analogue scale (VAS), where 0 means no pain, and 10 means the imaginable severest pain. The VAS value of each period is used to compare the difference of acupuncture pain between the placebo needle and the real needle.; A lower value represented a better outcome, which indicated that needles used induced less pain.	in the third acupuncture session in each period
Secondary	Acceptability of the Acupuncture Needle	After the third acupuncture of each period, participants are asked to show their acceptance toward the needles with a 5-point scale: very difficult to accept, a little difficult to accept, acceptable, easy to accept, very easy to accept.; The needle acceptability between the placebo needle and real needle are compared.; Data of the acceptability of the placebo needle included rows 1-5, i.e., rows of "placebo needle: very difficult to accept", "placebo needle: a little difficult to accept", "placebo needle: acceptable", "placebo needle: easy to accept" and "placebo needle: very easy to accept".; Data of the acceptability of the real needle included rows 6-10, i.e., rows of "real needle: very difficult to accept", "real needle: a little difficult to accept", "real needle: acceptable", "real needle: easy to accept" and "real needle: very easy to accept".	in the third acupuncture session in each period