Trial Outcomes & Findings for Comparison of Electrotherapies for Chronic Low Back Pain (NCT NCT01658735)
NCT ID: NCT01658735
Last Updated: 2015-03-09
Results Overview
Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
1 week
Results posted on
2015-03-09
Participant Flow
Participant milestones
| Measure |
H-Wave Device
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
36
|
38
|
|
Overall Study
COMPLETED
|
34
|
29
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
4
|
Reasons for withdrawal
| Measure |
H-Wave Device
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
3
|
Baseline Characteristics
Comparison of Electrotherapies for Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
48.5 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 12.0 • n=206 Participants
|
47.6 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
110 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Number of participants currently working at enrollment
Yes
|
29 participants
n=99 Participants
|
28 participants
n=107 Participants
|
31 participants
n=206 Participants
|
88 participants
n=7 Participants
|
|
Number of participants currently working at enrollment
No
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
7 participants
n=206 Participants
|
25 participants
n=7 Participants
|
|
Number of participants who have ever seen a Chiropractor for LBP
Yes
|
23 participants
n=99 Participants
|
23 participants
n=107 Participants
|
25 participants
n=206 Participants
|
71 participants
n=7 Participants
|
|
Number of participants who have ever seen a Chiropractor for LBP
No
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
13 participants
n=206 Participants
|
42 participants
n=7 Participants
|
|
Number of participants who have seen a Physician for their current LBP
Yes
|
23 participants
n=99 Participants
|
28 participants
n=107 Participants
|
27 participants
n=206 Participants
|
78 participants
n=7 Participants
|
|
Number of participants who have seen a Physician for their current LBP
No
|
16 participants
n=99 Participants
|
8 participants
n=107 Participants
|
11 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Number of participants who have been to a chronic pain clinic for their current LBP
Yes
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
1 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Number of participants who have been to a chronic pain clinic for their current LBP
No
|
34 participants
n=99 Participants
|
31 participants
n=107 Participants
|
37 participants
n=206 Participants
|
102 participants
n=7 Participants
|
|
Participants of participants who have ever had a MRI for their current LBP
Yes
|
17 participants
n=99 Participants
|
17 participants
n=107 Participants
|
17 participants
n=206 Participants
|
51 participants
n=7 Participants
|
|
Participants of participants who have ever had a MRI for their current LBP
No
|
22 participants
n=99 Participants
|
19 participants
n=107 Participants
|
21 participants
n=206 Participants
|
62 participants
n=7 Participants
|
|
Number of participants that have ever smoked greater than 100 cigarettes - lifetime
Yes
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
22 participants
n=7 Participants
|
|
Number of participants that have ever smoked greater than 100 cigarettes - lifetime
No
|
30 participants
n=99 Participants
|
32 participants
n=107 Participants
|
29 participants
n=206 Participants
|
91 participants
n=7 Participants
|
|
Number of participants who have ever seen a physical therapist for LBP
Yes
|
17 participants
n=99 Participants
|
18 participants
n=107 Participants
|
22 participants
n=206 Participants
|
57 participants
n=7 Participants
|
|
Number of participants who have ever seen a physical therapist for LBP
NO
|
22 participants
n=99 Participants
|
18 participants
n=107 Participants
|
16 participants
n=206 Participants
|
56 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 weekMeasure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in Oswestry Disability Index at 1 Week
|
-2.507 units on a scale
Interval -4.56 to -0.45
|
-4.725 units on a scale
Interval -6.94 to -2.51
|
-4.752 units on a scale
Interval -6.94 to -2.56
|
PRIMARY outcome
Timeframe: Week 4Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in Oswestry Disability Index at 4 Weeks
|
-5.002 units on a scale
Interval -7.51 to -2.5
|
-5.135 units on a scale
Interval -7.88 to -2.39
|
-4.581 units on a scale
Interval -7.25 to -1.91
|
PRIMARY outcome
Timeframe: Week 8Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in Oswestry Disability Index at 8 Weeks
|
-5.299 units on a scale
Interval -8.19 to -2.41
|
-5.135 units on a scale
Interval -7.88 to -2.39
|
-4.679 units on a scale
Interval -7.41 to -1.89
|
PRIMARY outcome
Timeframe: Week 12Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in Oswestry Disability Index at 12 Weeks
|
-5.388 units on a scale
Interval -8.47 to -2.3
|
-6.907 units on a scale
Interval -10.32 to -3.49
|
-5.612 units on a scale
Interval -8.82 to -2.4
|
SECONDARY outcome
Timeframe: Week 1Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure. The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in VAS Pain Score at 1 Week
|
-1.458 units on a scale
Interval -2.21 to -0.93
|
-1.929 units on a scale
Interval -2.75 to -1.11
|
-2.042 units on a scale
Interval -2.84 to -1.25
|
SECONDARY outcome
Timeframe: Week 4Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure. The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in VAS Pain Score at 4 Weeks
|
-2.017 units on a scale
Interval -2.9 to -1.13
|
-1.691 units on a scale
Interval -2.66 to -0.72
|
-1.843 units on a scale
Interval -2.79 to -0.9
|
SECONDARY outcome
Timeframe: Week 8Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure. The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in VAS Pain Score at 8 Weeks
|
-2.510 units on a scale
Interval -3.53 to -1.49
|
-2.147 units on a scale
Interval -3.28 to -1.02
|
-2.467 units on a scale
Interval -3.41 to -1.52
|
SECONDARY outcome
Timeframe: Week 12Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure. The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.
Outcome measures
| Measure |
H-Wave Device
n=39 Participants
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 Participants
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 Participants
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Change From Baseline in VAS Pain Score at 12 Weeks
|
-2.624 units on a scale
Interval -3.53 to -1.72
|
-1.922 units on a scale
Interval -2.91 to -0.93
|
-2.467 units on a scale
Interval -3.41 to -1.52
|
Adverse Events
H-Wave Device
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TENS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham Electrotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
H-Wave Device
n=39 participants at risk
H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
|
TENS
n=36 participants at risk
Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
|
Sham Electrotherapy
n=38 participants at risk
Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/39 • Within 12 weeks the participant was enrolled
|
2.8%
1/36 • Number of events 1 • Within 12 weeks the participant was enrolled
|
0.00%
0/38 • Within 12 weeks the participant was enrolled
|
|
Nervous system disorders
Increase in Lower Extremity Tingling/Sciatica
|
2.6%
1/39 • Number of events 1 • Within 12 weeks the participant was enrolled
|
0.00%
0/36 • Within 12 weeks the participant was enrolled
|
2.6%
1/38 • Number of events 1 • Within 12 weeks the participant was enrolled
|
|
Gastrointestinal disorders
Exacerbation of Irritable bowel syndrome
|
2.6%
1/39 • Number of events 1 • Within 12 weeks the participant was enrolled
|
0.00%
0/36 • Within 12 weeks the participant was enrolled
|
0.00%
0/38 • Within 12 weeks the participant was enrolled
|
|
Gastrointestinal disorders
Abdominal pain/Flank pain
|
0.00%
0/39 • Within 12 weeks the participant was enrolled
|
2.8%
1/36 • Number of events 1 • Within 12 weeks the participant was enrolled
|
0.00%
0/38 • Within 12 weeks the participant was enrolled
|
Additional Information
Matthew A Hughes, MD, MPH
University of Utah School of Medicine
Phone: 8015814800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place