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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.
blinding refers to subject blinding
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu | Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100053 | China |
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Volunteers were recruited from Guang'anmen Hospital of China Academy of Chinese Medical Sciences via poster advertisements between August 2013 and December 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Real Needle- Placebo Needle | Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial. real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. 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 will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions. |
| FG001 | Placebo Needle - Real Needle | Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial. placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture 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 will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Needle - Real Needle | Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | in the third acupuncture session in each period |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Needle- Placebo Needle | Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial. real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. 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 will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu, Director of the study | Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | 8610-010-88001124 | liuzhishun@aliyun.com.cn |
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| 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. |
|
| 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 |
| BG001 | Real Needle - Placebo Needle | Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Educational level | Number | participants |
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| Acupuncture experience | Number | participants |
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| Nervousness of acupuncture | Number | participants |
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| Acupuncture discomfort (vas) | The discomfort of acupuncture is assessed using visual analogue scale (VAS), where 0 means no discomfort, and 10 means the severest discomfort. A lower value represented a better outcome, which indicated that needles used induced less pain. | Median | Inter-Quartile Range | score |
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| Familiarity with needle sensation | Number | participants |
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| Type of needle sensation ever experienced | Number | participants |
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| Acceptability of acupuncture | Number | participants |
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| Preference of acupuncture | Number | participants |
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| OG001 | Real Needle- Placebo Needle | Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period. 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. |
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| 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. | Posted | Number | participants | in the third acupuncture session in each period |
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| 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". | Posted | Number | participants | in the third acupuncture session in each period |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | in the third acupuncture session in each period |
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| 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". | Posted | Number | participants | in the third acupuncture session in each period |
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| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo Needle - Real Needle | Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial. placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture 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 will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions. | 0 | 30 | 0 | 30 |
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| Pricking：Preferred period 2 |
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| Distending：Preferred period 1 |
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| Distending：No preference |
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| Distending：Preferred period 2 |
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| Soreness：Preferred period 1 |
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| Soreness：No preference |
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| Soreness：Preferred period 2 |
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| Spreading：Preferred period 1 |
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| Spreading：No preference |
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| Spreading：Preferred period 2 |
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| Placebo needle: Moderate |
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| Placebo needle: Severe |
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| Real needle: No |
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| Real needle: Mild |
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| Real needle: Moderate |
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| Real needle: Severe |
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| Placebo needle: acceptable |
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| Placebo needle: easy to accept |
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| Placebo needle: very easy to accept |
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| Real needle: very difficult to accept |
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| Real needle: a little difficult to accept |
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| Real needle: acceptable |
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| Real needle: easy to accept |
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| Real needle: very easy to accept |
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