Device Ineffective
Conditions
Keywords
subject blinding, placebo needle
Brief 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.
Detailed description
blinding refers to subject blinding
Interventions
DEVICEreal 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.
DEVICEplacebo 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.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | in the third acupuncture session in each period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Southampton Needle Sensation Questionnaire-Type of Needle Sensation | in the third acupuncture session in each period | 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. |
| Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | in the third acupuncture session in each period | 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. |
| Degree of Acupuncture Pain | in the third acupuncture session in each period | 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. |
| Acceptability of the Acupuncture Needle | in the third acupuncture session in each period | 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. |
Countries
China
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Real Needle - Placebo Needle | Placebo Needle - Real Needle | Total |
|---|---|---|---|
| Acceptability of acupuncture Acceptable | 10 participants | 10 participants | 20 participants |
| Acceptability of acupuncture A little difficult to accept | 1 participants | 0 participants | 1 participants |
| Acceptability of acupuncture Easy to accept | 5 participants | 5 participants | 10 participants |
| Acceptability of acupuncture no response | 8 participants | 7 participants | 15 participants |
| Acceptability of acupuncture Very difficult to accept | 1 participants | 0 participants | 1 participants |
| Acceptability of acupuncture Very easy to accept | 5 participants | 8 participants | 13 participants |
| Acupuncture discomfort (vas) | 0 score | 0.9 score | 0 score |
| Acupuncture experience >10 sessions | 13 participants | 10 participants | 23 participants |
| Acupuncture experience 1-5 sessions | 7 participants | 13 participants | 20 participants |
| Acupuncture experience 6-10 sessions | 2 participants | 0 participants | 2 participants |
| Acupuncture experience None | 8 participants | 7 participants | 15 participants |
| Age, Continuous | 48.90 years STANDARD_DEVIATION 16.74 | 49.47 years STANDARD_DEVIATION 14.54 | 49.18 years STANDARD_DEVIATION 15.55 |
| Educational level Secondary education and the below | 16 participants | 14 participants | 30 participants |
| Educational level Tertiary education | 14 participants | 16 participants | 30 participants |
| Familiarity with needle sensation no | 1 participants | 3 participants | 4 participants |
| Familiarity with needle sensation no response | 8 participants | 7 participants | 15 participants |
| Familiarity with needle sensation yes | 21 participants | 20 participants | 41 participants |
| Nervousness of acupuncture A little nervous | 7 participants | 7 participants | 14 participants |
| Nervousness of acupuncture No nervous | 14 participants | 16 participants | 30 participants |
| Nervousness of acupuncture no report | 8 participants | 7 participants | 15 participants |
| Nervousness of acupuncture Very nervous | 1 participants | 0 participants | 1 participants |
| Preference of acupuncture no response | 8 participants | 7 participants | 15 participants |
| Preference of acupuncture Not sure | 1 participants | 0 participants | 1 participants |
| Preference of acupuncture Yes | 21 participants | 23 participants | 44 participants |
| Region of Enrollment China | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 11 Participants | 19 Participants | 30 Participants |
| Sex: Female, Male Male | 19 Participants | 11 Participants | 30 Participants |
| Type of needle sensation ever experienced Distention | 20 participants | 18 participants | 38 participants |
| Type of needle sensation ever experienced Numbness | 17 participants | 9 participants | 26 participants |
| Type of needle sensation ever experienced Pricking | 19 participants | 10 participants | 29 participants |
| Type of needle sensation ever experienced Soreness | 17 participants | 16 participants | 33 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: in the third acupuncture session in each period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | LI4: Preferred period 1 | 1 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | LI4: No preference | 29 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | LI4: Preferred period 2 | 0 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | RN12: Preferred period 1 | 0 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | RN12: No preference | 26 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | RN12: Preferred period 2 | 4 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL25: Preferred period 1 | 2 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL25: No preference | 26 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL25: Preferred period 2 | 2 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL36: Preferred period 1 | 1 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL36: No preference | 29 participants |
| Placebo Needle - Real Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL36: Preferred period 2 | 0 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL36: No preference | 27 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | LI4: Preferred period 1 | 0 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL25: Preferred period 1 | 4 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | LI4: No preference | 30 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL36: Preferred period 1 | 2 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | LI4: Preferred period 2 | 0 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL25: No preference | 26 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | RN12: Preferred period 1 | 2 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL36: Preferred period 2 | 1 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | RN12: No preference | 26 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | BL25: Preferred period 2 | 0 participants |
| Real Needle- Placebo Needle | Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle. | RN12: Preferred period 2 | 2 participants |
p-value: >0.05Chi-squared
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.
Time frame: in the third acupuncture session in each period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Placebo needle: very difficult to accept | 0 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Placebo needle: a little difficult to accept | 0 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Placebo needle: acceptable | 15 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Placebo needle: easy to accept | 5 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Placebo needle: very easy to accept | 10 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Real needle: very difficult to accept | 0 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Real needle: a little difficult to accept | 2 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Real needle: acceptable | 14 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Real needle: easy to accept | 8 participants |
| Placebo Needle - Real Needle | Acceptability of the Acupuncture Needle | Real needle: very easy to accept | 6 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Real needle: acceptable | 15 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Placebo needle: very difficult to accept | 0 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Real needle: very difficult to accept | 0 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Placebo needle: a little difficult to accept | 1 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Real needle: very easy to accept | 5 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Placebo needle: acceptable | 11 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Real needle: a little difficult to accept | 2 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Placebo needle: easy to accept | 12 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Real needle: easy to accept | 8 participants |
| Real Needle- Placebo Needle | Acceptability of the Acupuncture Needle | Placebo needle: very easy to accept | 6 participants |
p-value: =0.04895% CI: [1.01, 2.64]Generalized Estimating Equation
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.
Time frame: in the third acupuncture session in each period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Needle - Real Needle | Degree of Acupuncture Pain | placobo needle | 3.02 units on a scale | Standard Deviation 1.87 |
| Placebo Needle - Real Needle | Degree of Acupuncture Pain | real needle | 3.70 units on a scale | Standard Deviation 2.22 |
| Real Needle- Placebo Needle | Degree of Acupuncture Pain | placobo needle | 2.73 units on a scale | Standard Deviation 1.41 |
| Real Needle- Placebo Needle | Degree of Acupuncture Pain | real needle | 3.46 units on a scale | Standard Deviation 1.98 |
p-value: =0.006t-test, 2 sided
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.
Time frame: in the third acupuncture session in each period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: No | 0 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: Severe | 0 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: Mild | 11 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: Mild | 14 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: Moderate | 16 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: No | 1 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: Severe | 3 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: Moderate | 15 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: Severe | 1 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: No | 1 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: No | 3 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: Mild | 17 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: Moderate | 9 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: Mild | 12 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Real needle: Moderate | 16 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Degree of Needle Sensation | Placebo needle: Severe | 1 participants |
p-value: 0.00795% CI: [1.26, 4.4]Generalized Estimating Equation
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.
Time frame: in the third acupuncture session in each period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Soreness：Preferred period 2 | 8 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Pricking：Preferred period 2 | 2 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Spreading：No preference | 24 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Distending：Preferred period 1 | 1 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Soreness：No preference | 18 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Distending：No preference | 20 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Pricking：Preferred period 1 | 8 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Spreading：Preferred period 2 | 3 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Pricking：No preference | 20 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Spreading：Preferred period 1 | 3 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Distending：Preferred period 2 | 9 participants |
| Placebo Needle - Real Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Soreness：Preferred period 1 | 4 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Distending：Preferred period 2 | 2 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Soreness：Preferred period 1 | 10 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Soreness：No preference | 16 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Soreness：Preferred period 2 | 4 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Spreading：Preferred period 1 | 6 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Spreading：No preference | 20 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Spreading：Preferred period 2 | 4 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Pricking：No preference | 17 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Pricking：Preferred period 2 | 7 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Distending：Preferred period 1 | 7 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Pricking：Preferred period 1 | 6 participants |
| Real Needle- Placebo Needle | Southampton Needle Sensation Questionnaire-Type of Needle Sensation | Distending：No preference | 21 participants |