Trial Outcomes & Findings for A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies (NCT NCT02881112)
NCT ID: NCT02881112
Last Updated: 2020-04-06
Results Overview
Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary.
COMPLETED
NA
180 participants
Pain scores collected daily, up to 20 weeks.
2020-04-06
Participant Flow
Participant milestones
| Measure |
Active Treatment Arm
Treatment with Provant Therapy System
Provant Therapy System: Treatment with the Provant Therapy System
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies
Baseline characteristics by cohort
| Measure |
Active Treatment Arm
n=180 Participants
Treatment with Provant Therapy System
Provant Therapy System: Treatment with the Provant Therapy System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
105 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
75 Participants
n=5 Participants
|
|
Age, Continuous
|
60.48 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
180 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pain scores collected daily, up to 20 weeks.Population: Subjects recording both a Baseline and End of Study score were included in the NPRS analysis.
Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary.
Outcome measures
| Measure |
Active Treatment Arm
n=75 Participants
Treatment with Provant Therapy System
Provant Therapy System: Treatment with the Provant Therapy System
|
|---|---|
|
Pain Intensity Assessment
|
-2.785 score on a scale
Standard Deviation 3.3039
|
Adverse Events
Active Treatment Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication Rights. Independent analysis and/or publication of data generated or arising from the performance of this Agreement is not permitted without the prior written consent of Regenesis. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
- Publication restrictions are in place
Restriction type: OTHER