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Trial record 2 of 58450 for:    Placebo

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

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ClinicalTrials.gov Identifier: NCT01948375
Recruitment Status : Completed
First Posted : September 23, 2013
Results First Posted : July 8, 2014
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Device Ineffective
Interventions Device: real needle- placebo needle
Device: placebo needle - real needle
Enrollment 60
Recruitment Details Volunteers were recruited from Guang’anmen Hospital of China Academy of Chinese Medical Sciences via poster advertisements between August 2013 and December 2013.
Pre-assignment Details  
Arm/Group Title Real Needle- Placebo Needle Placebo Needle - Real Needle
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Placebo Needle - Real Needle Real Needle - Placebo Needle Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
49.47  (14.54) 48.90  (16.74) 49.18  (15.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
19
  63.3%
11
  36.7%
30
  50.0%
Male
11
  36.7%
19
  63.3%
30
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 30 participants 30 participants 60 participants
30 30 60
Educational level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Secondary education and the below 14 16 30
Tertiary education 16 14 30
Acupuncture experience  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
None 7 8 15
1-5 sessions 13 7 20
6-10 sessions 0 2 2
>10 sessions 10 13 23
Nervousness of acupuncture  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
No nervous 16 14 30
A little nervous 7 7 14
Very nervous 0 1 1
no report 7 8 15
Acupuncture discomfort (vas)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Score
Number Analyzed 30 participants 30 participants 60 participants
0.9
(0 to 2.0)
0
(0 to 3.5)
0
(0 to 2.0)
[1]
Measure Description:

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.

Familiarity with needle sensation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
yes 20 21 41
no 3 1 4
no response 7 8 15
Type of needle sensation ever experienced  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Distention 18 20 38
Soreness 16 17 33
Pricking 10 19 29
Numbness 9 17 26
Acceptability of acupuncture  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Very difficult to accept 0 1 1
A little difficult to accept 0 1 1
Acceptable 10 10 20
Easy to accept 5 5 10
Very easy to accept 8 5 13
no response 7 8 15
Preference of acupuncture  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Yes 23 21 44
Not sure 0 1 1
no response 7 8 15
1.Primary Outcome
Title Proportion of Volunteers’Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
Hide Description

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.

Time Frame in the third acupuncture session in each period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Needle - Real Needle Real Needle- Placebo Needle
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: participants
LI4: Preferred period 1 1 0
LI4: No preference 29 30
LI4: Preferred period 2 0 0
RN12: Preferred period 1 0 2
RN12: No preference 26 26
RN12: Preferred period 2 4 2
BL25: Preferred period 1 2 4
BL25: No preference 26 26
BL25: Preferred period 2 2 0
BL36: Preferred period 1 1 2
BL36: No preference 29 27
BL36: Preferred period 2 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Needle - Real Needle, Real Needle- Placebo Needle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Southampton Needle Sensation Questionnaire—Type of Needle Sensation
Hide Description 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.
Time Frame in the third acupuncture session in each period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Needle - Real Needle Real Needle- Placebo Needle
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: participants
Pricking:Preferred period 1 8 6
Pricking:No preference 20 17
Pricking:Preferred period 2 2 7
Distending:Preferred period 1 1 7
Distending:No preference 20 21
Distending:Preferred period 2 9 2
Soreness:Preferred period 1 4 10
Soreness:No preference 18 16
Soreness:Preferred period 2 8 4
Spreading:Preferred period 1 3 6
Spreading:No preference 24 20
Spreading:Preferred period 2 3 4
3.Secondary Outcome
Title Southampton Needle Sensation Questionnaire—Degree of Needle Sensation
Hide Description

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".

Time Frame in the third acupuncture session in each period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Needle - Real Needle Real Needle- Placebo Needle
Hide Arm/Group Description:

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

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.

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

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.

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: participants
Placebo needle: No 1 3
Placebo needle: Mild 14 17
Placebo needle: Moderate 15 9
Placebo needle: Severe 0 1
Real needle: No 0 1
Real needle: Mild 11 12
Real needle: Moderate 16 16
Real needle: Severe 3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Needle - Real Needle, Real Needle- Placebo Needle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments For the comparison of direct effect of placebo needle and real needle, p=0.007
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.35
Confidence Interval 95%
1.26 to 4.40
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Degree of Acupuncture Pain
Hide Description

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.

Time Frame in the third acupuncture session in each period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Needle - Real Needle Real Needle- Placebo Needle
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
placobo needle 3.02  (1.87) 2.73  (1.41)
real needle 3.70  (2.22) 3.46  (1.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Needle - Real Needle, Real Needle- Placebo Needle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.006
Comments

for the comparison of difference of acupuncture pain in two periods between the two groups,t=-2.88, p=0.006.

t=-2.88 refers to the t value of t test.

Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Acceptability of the Acupuncture Needle
Hide Description

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".

Time Frame in the third acupuncture session in each period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Needle - Real Needle Real Needle- Placebo Needle
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: participants
Placebo needle: very difficult to accept 0 0
Placebo needle: a little difficult to accept 0 1
Placebo needle: acceptable 15 11
Placebo needle: easy to accept 5 12
Placebo needle: very easy to accept 10 6
Real needle: very difficult to accept 0 0
Real needle: a little difficult to accept 2 2
Real needle: acceptable 14 15
Real needle: easy to accept 8 8
Real needle: very easy to accept 6 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Needle - Real Needle, Real Needle- Placebo Needle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.048
Comments For the comparison of direct effect of placebo needle and real needle, p=0.048
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.63
Confidence Interval 95%
1.01 to 2.64
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Real Needle- Placebo Needle Placebo Needle - Real Needle
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Real Needle- Placebo Needle Placebo Needle - Real Needle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Real Needle- Placebo Needle Placebo Needle - Real Needle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Real Needle- Placebo Needle Placebo Needle - Real Needle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Zhishun Liu, Director of the study
Organization: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Phone: 8610-010-88001124
Responsible Party: Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01948375     History of Changes
Other Study ID Numbers: 2012BAI24B01-0
First Submitted: September 8, 2013
First Posted: September 23, 2013
Results First Submitted: May 5, 2014
Results First Posted: July 8, 2014
Last Update Posted: January 9, 2018