Trial Outcomes & Findings for Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST) (NCT NCT01094782)
NCT ID: NCT01094782
Last Updated: 2022-05-02
Results Overview
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
254 participants
Primary outcome timeframe
Start of Week 1
Results posted on
2022-05-02
Participant Flow
254 participants were enrolled in the study and were randomly assigned to one of the 6 study arms at "Visit 1". 6 participants were later found to be ineligible to continue to participate (e.g. drug screen, medical history, no longer interested) further in "Visit 1" and they did not recieve study intervention.
Participant milestones
| Measure |
Healthy - True Acupuncture
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
34
|
56
|
42
|
38
|
|
Overall Study
COMPLETED
|
31
|
29
|
31
|
45
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
3
|
11
|
11
|
8
|
Reasons for withdrawal
| Measure |
Healthy - True Acupuncture
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
1
|
5
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
2
|
1
|
4
|
|
Overall Study
Positive Drug Screen
|
2
|
2
|
1
|
1
|
3
|
2
|
|
Overall Study
Sensory Deficit at Site of QST
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Unable to Complete Questionnaires
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Healthy Subject Had Pain
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Hypertension
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Wrong Pain Condition
|
0
|
0
|
0
|
2
|
1
|
1
|
|
Overall Study
Recent Interventional Injection
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Low Visual Analog Scale (VAS) Score
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Noncompliance With Study Schedule
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)
Baseline characteristics by cohort
| Measure |
Healthy - True Acupuncture
n=39 Participants
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=39 Participants
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=34 Participants
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=56 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=42 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=38 Participants
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
247 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
133 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
115 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
34 participants
n=5 Participants
|
56 participants
n=4 Participants
|
42 participants
n=21 Participants
|
38 participants
n=10 Participants
|
248 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Start of Week 1Population: Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.
Outcome measures
| Measure |
Healthy - True Acupuncture
n=34 Participants
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=30 Participants
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=31 Participants
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=46 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=33 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=30 Participants
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants
|
49.9 Degrees Celcius
Standard Deviation 1.7
|
50.5 Degrees Celcius
Standard Deviation 1.3
|
49.9 Degrees Celcius
Standard Deviation 1.7
|
49.5 Degrees Celcius
Standard Deviation 2.4
|
49.7 Degrees Celcius
Standard Deviation 2.2
|
50.1 Degrees Celcius
Standard Deviation 2
|
PRIMARY outcome
Timeframe: End of Week 2Population: Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.
Outcome measures
| Measure |
Healthy - True Acupuncture
n=34 Participants
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=30 Participants
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=31 Participants
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=46 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=33 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=30 Participants
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants
|
49.8 Degrees Celcius
Standard Deviation 1.6
|
50.3 Degrees Celcius
Standard Deviation 1.6
|
50.2 Degrees Celcius
Standard Deviation 1.6
|
49.6 Degrees Celcius
Standard Deviation 2.8
|
50.3 Degrees Celcius
Standard Deviation 2.1
|
50.0 Degrees Celcius
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: End of Week 4Population: Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.
Outcome measures
| Measure |
Healthy - True Acupuncture
n=34 Participants
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=30 Participants
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=31 Participants
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=46 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=33 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=30 Participants
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants
|
49.9 Degrees Celcius
Standard Deviation 1.6
|
50.3 Degrees Celcius
Standard Deviation 1.7
|
50.1 Degrees Celcius
Standard Deviation 1.3
|
50.1 Degrees Celcius
Standard Deviation 1.9
|
49.8 Degrees Celcius
Standard Deviation 2.9
|
49.2 Degrees Celcius
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: Start of Week 1Population: Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.
Outcome measures
| Measure |
Healthy - True Acupuncture
n=34 Participants
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=30 Participants
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=31 Participants
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=46 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=33 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=30 Participants
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants
|
1.2 Degrees Celcius
Standard Deviation 3
|
0.5 Degrees Celcius
Standard Deviation 1
|
2.1 Degrees Celcius
Standard Deviation 5
|
2.5 Degrees Celcius
Standard Deviation 5.5
|
2.8 Degrees Celcius
Standard Deviation 6.1
|
1.1 Degrees Celcius
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: End of Week 2Population: Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.
Outcome measures
| Measure |
Healthy - True Acupuncture
n=34 Participants
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=30 Participants
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=31 Participants
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=46 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=33 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=30 Participants
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants
|
1.7 Degrees Celcius
Standard Deviation 4.1
|
0.3 Degrees Celcius
Standard Deviation 1.3
|
1.9 Degrees Celcius
Standard Deviation 3.9
|
2.2 Degrees Celcius
Standard Deviation 5.6
|
2.8 Degrees Celcius
Standard Deviation 5.8
|
2.4 Degrees Celcius
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: End of Week 4Population: Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.
Outcome measures
| Measure |
Healthy - True Acupuncture
n=34 Participants
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=30 Participants
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=31 Participants
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=46 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=33 Participants
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=31 Participants
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants
|
1.8 Degrees Celcius
Standard Deviation 4.2
|
0.1 Degrees Celcius
Standard Deviation 0.3
|
2 Degrees Celcius
Standard Deviation 4.5
|
3.7 Degrees Celcius
Standard Deviation 7.4
|
3.3 Degrees Celcius
Standard Deviation 7.1
|
1.9 Degrees Celcius
Standard Deviation 5.7
|
Adverse Events
Healthy - True Acupuncture
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy - Sham Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy - No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pain - True Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pain - Sham Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pain - No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy - True Acupuncture
n=39 participants at risk
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Healthy - Sham Acupuncture
n=39 participants at risk
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Healthy - No Treatment
n=34 participants at risk
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
Pain - True Acupuncture
n=56 participants at risk
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received true acupuncture treatment (the needles punctured the skin).
|
Pain - Sham Acupuncture
n=42 participants at risk
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.
This group received sham acupuncture treatment (the needles did not puncture the skin).
|
Pain - No Treatment
n=38 participants at risk
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Feeling of heaviness and muscle spasm at site of acupuncture
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.
|
0.00%
0/39 • Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.
|
0.00%
0/34 • Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.
|
0.00%
0/56 • Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.
|
0.00%
0/42 • Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.
|
0.00%
0/38 • Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place