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

Study Overview
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Brief Summary
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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
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blinding refers to subject blinding

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

Conditions
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Device Ineffective

Intervention / Treatment
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* Device: real needle- placebo needle
* Device: placebo needle - real needle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real needle- placebo needle<br>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<br>* 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.<br>|
| Experimental: placebo needle - real needle<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subject blinding, placebo needle