Trial Outcomes & Findings for A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle (NCT NCT01948375)
NCT ID: NCT01948375
Last Updated: 2018-01-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
in the third acupuncture session in each period
Results posted on
2018-01-09
Participant Flow
Volunteers were recruited from Guang'anmen Hospital of China Academy of Chinese Medical Sciences via poster advertisements between August 2013 and December 2013.
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle
Baseline characteristics by cohort
| Measure |
Placebo Needle - Real Needle
n=30 Participants
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.
|
Real Needle - Placebo Needle
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.47 years
STANDARD_DEVIATION 14.54 • n=5 Participants
|
48.90 years
STANDARD_DEVIATION 16.74 • n=7 Participants
|
49.18 years
STANDARD_DEVIATION 15.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Educational level
Secondary education and the below
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Educational level
Tertiary education
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Acupuncture experience
None
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Acupuncture experience
1-5 sessions
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Acupuncture experience
6-10 sessions
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Acupuncture experience
>10 sessions
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Nervousness of acupuncture
No nervous
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Nervousness of acupuncture
A little nervous
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Nervousness of acupuncture
Very nervous
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Nervousness of acupuncture
no report
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Acupuncture discomfort (vas)
|
0.9 score
n=5 Participants
|
0 score
n=7 Participants
|
0 score
n=5 Participants
|
|
Familiarity with needle sensation
yes
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Familiarity with needle sensation
no
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Familiarity with needle sensation
no response
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Type of needle sensation ever experienced
Distention
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Type of needle sensation ever experienced
Soreness
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Type of needle sensation ever experienced
Pricking
|
10 participants
n=5 Participants
|
19 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Type of needle sensation ever experienced
Numbness
|
9 participants
n=5 Participants
|
17 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Acceptability of acupuncture
Very difficult to accept
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Acceptability of acupuncture
A little difficult to accept
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Acceptability of acupuncture
Acceptable
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Acceptability of acupuncture
Easy to accept
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Acceptability of acupuncture
Very easy to accept
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Acceptability of acupuncture
no response
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Preference of acupuncture
Yes
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Preference of acupuncture
Not sure
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Preference of acupuncture
no response
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: in the third acupuncture session in each periodThe 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.
Outcome measures
| Measure |
Placebo Needle - Real Needle
n=30 Participants
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.
|
Real Needle- Placebo Needle
n=30 Participants
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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|---|---|---|
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Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
LI4: No preference
|
29 participants
|
30 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
LI4: Preferred period 2
|
0 participants
|
0 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
RN12: Preferred period 1
|
0 participants
|
2 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
RN12: No preference
|
26 participants
|
26 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
RN12: Preferred period 2
|
4 participants
|
2 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
BL25: Preferred period 1
|
2 participants
|
4 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
BL25: No preference
|
26 participants
|
26 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
BL25: Preferred period 2
|
2 participants
|
0 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
BL36: Preferred period 1
|
1 participants
|
2 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
BL36: No preference
|
29 participants
|
27 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
BL36: Preferred period 2
|
0 participants
|
1 participants
|
|
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
LI4: Preferred period 1
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: in the third acupuncture session in each periodThis 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.
Outcome measures
| Measure |
Placebo Needle - Real Needle
n=30 Participants
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.
|
Real Needle- Placebo Needle
n=30 Participants
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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|---|---|---|
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Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Spreading：Preferred period 2
|
3 participants
|
4 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Pricking：Preferred period 1
|
8 participants
|
6 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Pricking：No preference
|
20 participants
|
17 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Pricking：Preferred period 2
|
2 participants
|
7 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Distending：Preferred period 1
|
1 participants
|
7 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Distending：No preference
|
20 participants
|
21 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Distending：Preferred period 2
|
9 participants
|
2 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Soreness：Preferred period 1
|
4 participants
|
10 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Soreness：No preference
|
18 participants
|
16 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Soreness：Preferred period 2
|
8 participants
|
4 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Spreading：Preferred period 1
|
3 participants
|
6 participants
|
|
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Spreading：No preference
|
24 participants
|
20 participants
|
SECONDARY outcome
Timeframe: in the third acupuncture session in each periodThe 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".
Outcome measures
| Measure |
Placebo Needle - Real Needle
n=30 Participants
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.
|
Real Needle- Placebo Needle
n=30 Participants
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.
|
|---|---|---|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Real needle: Mild
|
11 participants
|
12 participants
|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Placebo needle: No
|
1 participants
|
3 participants
|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Placebo needle: Mild
|
14 participants
|
17 participants
|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Placebo needle: Moderate
|
15 participants
|
9 participants
|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Placebo needle: Severe
|
0 participants
|
1 participants
|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Real needle: No
|
0 participants
|
1 participants
|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Real needle: Moderate
|
16 participants
|
16 participants
|
|
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Real needle: Severe
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: in the third acupuncture session in each periodThe 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.
Outcome measures
| Measure |
Placebo Needle - Real Needle
n=30 Participants
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.
|
Real Needle- Placebo Needle
n=30 Participants
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.
|
|---|---|---|
|
Degree of Acupuncture Pain
placobo needle
|
3.02 units on a scale
Standard Deviation 1.87
|
2.73 units on a scale
Standard Deviation 1.41
|
|
Degree of Acupuncture Pain
real needle
|
3.70 units on a scale
Standard Deviation 2.22
|
3.46 units on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: in the third acupuncture session in each periodAfter 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".
Outcome measures
| Measure |
Placebo Needle - Real Needle
n=30 Participants
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.
|
Real Needle- Placebo Needle
n=30 Participants
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.
|
|---|---|---|
|
Acceptability of the Acupuncture Needle
Placebo needle: very difficult to accept
|
0 participants
|
0 participants
|
|
Acceptability of the Acupuncture Needle
Placebo needle: a little difficult to accept
|
0 participants
|
1 participants
|
|
Acceptability of the Acupuncture Needle
Placebo needle: acceptable
|
15 participants
|
11 participants
|
|
Acceptability of the Acupuncture Needle
Placebo needle: easy to accept
|
5 participants
|
12 participants
|
|
Acceptability of the Acupuncture Needle
Placebo needle: very easy to accept
|
10 participants
|
6 participants
|
|
Acceptability of the Acupuncture Needle
Real needle: very difficult to accept
|
0 participants
|
0 participants
|
|
Acceptability of the Acupuncture Needle
Real needle: a little difficult to accept
|
2 participants
|
2 participants
|
|
Acceptability of the Acupuncture Needle
Real needle: acceptable
|
14 participants
|
15 participants
|
|
Acceptability of the Acupuncture Needle
Real needle: easy to accept
|
8 participants
|
8 participants
|
|
Acceptability of the Acupuncture Needle
Real needle: very easy to accept
|
6 participants
|
5 participants
|
Adverse Events
Real Needle- Placebo Needle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Needle - Real Needle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Zhishun Liu, Director of the study
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Phone: 8610-010-88001124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place