Trial Outcomes & Findings for Effect of Acupuncture and Pain Medication on Radicular Pain Using QST (NCT NCT01678586)
NCT ID: NCT01678586
Last Updated: 2024-04-23
Results Overview
Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.
Results posted on
2024-04-23
Participant Flow
Participant milestones
| Measure |
True Acupuncture
Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
Acupuncture: In true acupuncture the needles penetrate the skin.
|
Sham Acupuncture
Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin.
|
Gabapentin
Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
|
Sham Gabapentin
Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
11
|
14
|
|
Overall Study
COMPLETED
|
14
|
15
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
Baseline characteristics by cohort
| Measure |
True Acupuncture
n=15 Participants
Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
Acupuncture: In true acupuncture the needles penetrate the skin.
|
Sham Acupuncture
n=16 Participants
Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin.
|
Gabapentin
n=11 Participants
Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
|
Sham Gabapentin
n=14 Participants
Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
|
Total
n=56 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Continuous
|
55.43 years
STANDARD_DEVIATION 12.33 • n=5 Participants
|
53.07 years
STANDARD_DEVIATION 9.28 • n=7 Participants
|
54.89 years
STANDARD_DEVIATION 13.78 • n=5 Participants
|
55.25 years
STANDARD_DEVIATION 6.08 • n=4 Participants
|
54.66 years
STANDARD_DEVIATION 10.37 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
11 participants
n=5 Participants
|
14 participants
n=4 Participants
|
56 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.Population: Enrolled participants who didn't withdraw, were not withdrawn by the investigator.
Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant.
Outcome measures
| Measure |
True Acupuncture
n=14 Participants
Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
Acupuncture: In true acupuncture the needles penetrate the skin.
|
Sham Acupuncture
n=15 Participants
Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin.
|
Gabapentin
n=9 Participants
Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
|
Sham Gabapentin
n=12 Participants
Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
|
|---|---|---|---|---|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 4 Cold Pain
|
11.01 degree celsius
Standard Deviation 10.22
|
9.55 degree celsius
Standard Deviation 9.66
|
9.09 degree celsius
Standard Deviation 9.89
|
14.13 degree celsius
Standard Deviation 10.79
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 1 Cold Sensation
|
26.41 degree celsius
Standard Deviation 5.01
|
26.54 degree celsius
Standard Deviation 2.44
|
27.92 degree celsius
Standard Deviation 2.22
|
24.25 degree celsius
Standard Deviation 4.27
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 1 Warm Sensation
|
38.43 degree celsius
Standard Deviation 4.03
|
39.57 degree celsius
Standard Deviation 4.63
|
38.49 degree celsius
Standard Deviation 4.89
|
39.90 degree celsius
Standard Deviation 4.61
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 1 Heat Pain
|
45.77 degree celsius
Standard Deviation 5.08
|
47.05 degree celsius
Standard Deviation 3.55
|
46.31 degree celsius
Standard Deviation 4.04
|
46.34 degree celsius
Standard Deviation 4.33
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 1 Cold pain
|
11.11 degree celsius
Standard Deviation 11.77
|
8.20 degree celsius
Standard Deviation 8.76
|
9.65 degree celsius
Standard Deviation 10.87
|
9.87 degree celsius
Standard Deviation 10.53
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 4 Cold Sensation
|
26.04 degree celsius
Standard Deviation 3.99
|
25.11 degree celsius
Standard Deviation 6.73
|
28.38 degree celsius
Standard Deviation 5.78
|
26.35 degree celsius
Standard Deviation 3.90
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 4 Warm Sensation
|
37.56 degree celsius
Standard Deviation 3.91
|
39.15 degree celsius
Standard Deviation 3.65
|
37.11 degree celsius
Standard Deviation 3.45
|
37.50 degree celsius
Standard Deviation 3.40
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 4 Heat Pain
|
46.15 degree celsius
Standard Deviation 3.46
|
47.51 degree celsius
Standard Deviation 2.41
|
45.92 degree celsius
Standard Deviation 4.07
|
45.34 degree celsius
Standard Deviation 4.70
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 7 Cold
|
26.17 degree celsius
Standard Deviation 3.23
|
25.12 degree celsius
Standard Deviation 2.10
|
27.04 degree celsius
Standard Deviation 2.28
|
26.25 degree celsius
Standard Deviation 3.96
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 7 Warm
|
38.38 degree celsius
Standard Deviation 4.34
|
39.09 degree celsius
Standard Deviation 2.94
|
37.59 degree celsius
Standard Deviation 3.64
|
38.33 degree celsius
Standard Deviation 3.94
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 7 Heat Pain
|
46.85 degree celsius
Standard Deviation 2.96
|
47.69 degree celsius
Standard Deviation 2.56
|
46.73 degree celsius
Standard Deviation 1.91
|
44.64 degree celsius
Standard Deviation 4.71
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Visit 7 Cold Pain
|
10.47 degree celsius
Standard Deviation 8.87
|
8.42 degree celsius
Standard Deviation 9.98
|
12.63 degree celsius
Standard Deviation 10.05
|
13.82 degree celsius
Standard Deviation 8.80
|
PRIMARY outcome
Timeframe: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.Population: Enrolled participants who didn't withdraw, were not withdrawn by the investigator.
Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant.
Outcome measures
| Measure |
True Acupuncture
n=14 Participants
Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
Acupuncture: In true acupuncture the needles penetrate the skin.
|
Sham Acupuncture
n=15 Participants
Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin.
|
Gabapentin
n=9 Participants
Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
|
Sham Gabapentin
n=12 Participants
Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
|
|---|---|---|---|---|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
Visit 1 tolerance to 47 celsius heat simulation
|
27.86 Seconds
Standard Deviation 25.39
|
27.56 Seconds
Standard Deviation 24.15
|
29.59 Seconds
Standard Deviation 28.43
|
23.63 Seconds
Standard Deviation 24.40
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
visit 7 heat pain threshold
|
49.57 Seconds
Standard Deviation 2.39
|
50.34 Seconds
Standard Deviation 1.56
|
49.8 Seconds
Standard Deviation 2.01
|
48.40 Seconds
Standard Deviation 3.74
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
visit 1 cold pain threshold
|
5.16 Seconds
Standard Deviation 6.78
|
4.7 Seconds
Standard Deviation 6.82
|
3.89 Seconds
Standard Deviation 8.58
|
6.8 Seconds
Standard Deviation 9.68
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
visit 4 heat pain threshold
|
49.53 Seconds
Standard Deviation 1.96
|
50.39 Seconds
Standard Deviation 1.46
|
48.71 Seconds
Standard Deviation 2.91
|
48.55 Seconds
Standard Deviation 3.79
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
visit 4 cold pain threshold
|
3.72 Seconds
Standard Deviation 6.95
|
2.1 Seconds
Standard Deviation 4.43
|
7.09 Seconds
Standard Deviation 8.53
|
7.05 Seconds
Standard Deviation 9.45
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
Visit 4 tolerance to 47 celsius heat simulation
|
28.36 Seconds
Standard Deviation 26.67
|
29.1 Seconds
Standard Deviation 24.85
|
23.69 Seconds
Standard Deviation 26.44
|
25.23 Seconds
Standard Deviation 26.49
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
visit 7 cold pain threshold
|
2.7 Seconds
Standard Deviation 4.36
|
2.38 Seconds
Standard Deviation 6.42
|
8.18 Seconds
Standard Deviation 9.38
|
5.7 Seconds
Standard Deviation 9.39
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
Visit 7 tolerance to 47 celsius heat simulation
|
29.28 Seconds
Standard Deviation 25.55
|
32.06 Seconds
Standard Deviation 22.43
|
29.07 Seconds
Standard Deviation 29.28
|
24.85 Seconds
Standard Deviation 26.13
|
|
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
visit 1 heat pain threshold
|
48.95 Seconds
Standard Deviation 2.86
|
49.93 Seconds
Standard Deviation 2.39
|
49.59 Seconds
Standard Deviation 2.49
|
48.95 Seconds
Standard Deviation 4.02
|
Adverse Events
True Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Acupuncture
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Gabapentin
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 |
True Acupuncture
n=15 participants at risk
Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
Acupuncture: In true acupuncture the needles penetrate the skin.
|
Sham Acupuncture
n=16 participants at risk
Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin.
|
Gabapentin
n=11 participants at risk
Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
|
Sham Gabapentin
n=14 participants at risk
Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Redness
|
0.00%
0/15 • The PI will monitor study outcomes. A monthly study staff meeting will be held to review the study progress and discuss any adverse event during study conduction. Adverse event were monitored through study completion, an average of 3 months.
Adverse events will be reported to the PHRC in accordance with the PHRC unanticipated problems including adverse events guidelines. \<http://healthcare.partners.org/phsirb/adverse\_events.htm\>.
|
6.2%
1/16 • Number of events 1 • The PI will monitor study outcomes. A monthly study staff meeting will be held to review the study progress and discuss any adverse event during study conduction. Adverse event were monitored through study completion, an average of 3 months.
Adverse events will be reported to the PHRC in accordance with the PHRC unanticipated problems including adverse events guidelines. \<http://healthcare.partners.org/phsirb/adverse\_events.htm\>.
|
0.00%
0/11 • The PI will monitor study outcomes. A monthly study staff meeting will be held to review the study progress and discuss any adverse event during study conduction. Adverse event were monitored through study completion, an average of 3 months.
Adverse events will be reported to the PHRC in accordance with the PHRC unanticipated problems including adverse events guidelines. \<http://healthcare.partners.org/phsirb/adverse\_events.htm\>.
|
0.00%
0/14 • The PI will monitor study outcomes. A monthly study staff meeting will be held to review the study progress and discuss any adverse event during study conduction. Adverse event were monitored through study completion, an average of 3 months.
Adverse events will be reported to the PHRC in accordance with the PHRC unanticipated problems including adverse events guidelines. \<http://healthcare.partners.org/phsirb/adverse\_events.htm\>.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place