Trial Outcomes & Findings for ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation (NCT NCT04803214)
NCT ID: NCT04803214
Last Updated: 2025-12-31
Results Overview
Comparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data. ODI is measured on a scale of 0 to 100 where a lower score is a better outcome.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
1 year
Results posted on
2025-12-31
Participant Flow
386 participants were screened across 25 clinical sites. The first participant was enrolled in July 2021 and the last participant was enrolled in July 2023.
Of the 386 participants screened, 203 were randomized and attended at least one follow-up visit. The protocol and analysis plan required randomized patients attend at least one follow-up visit to be included in analyses.
Participant milestones
| Measure |
Treatment (ReActiv8)
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year. Optimal medical management (OMM).
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
104
|
|
Overall Study
1.5 Month Follow up
|
97
|
99
|
|
Overall Study
3 Month Follow up
|
96
|
97
|
|
Overall Study
6 Month Follow up
|
95
|
98
|
|
Overall Study
12 Month Follow up
|
94
|
94
|
|
Overall Study
COMPLETED
|
94
|
94
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Treatment (ReActiv8)
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year. Optimal medical management (OMM).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Missed 12 month visit
|
0
|
3
|
Baseline Characteristics
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Baseline characteristics by cohort
| Measure |
Treatment (ReActiv8)
n=99 Participants
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
n=104 Participants
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 11 • n=1000 Participants
|
48 years
STANDARD_DEVIATION 13 • n=1986 Participants
|
47 years
STANDARD_DEVIATION 12 • n=2008 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=1000 Participants
|
68 Participants
n=1986 Participants
|
126 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=1000 Participants
|
36 Participants
n=1986 Participants
|
77 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=1000 Participants
|
4 Participants
n=1986 Participants
|
8 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=1000 Participants
|
100 Participants
n=1986 Participants
|
195 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=1000 Participants
|
97 Participants
n=1986 Participants
|
189 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
4 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=1000 Participants
|
104 participants
n=1986 Participants
|
203 participants
n=2008 Participants
|
|
Body Mass Index (BMI)
|
29 kg/m^2
STANDARD_DEVIATION 4 • n=1000 Participants
|
28 kg/m^2
STANDARD_DEVIATION 4 • n=1986 Participants
|
29 kg/m^2
STANDARD_DEVIATION 4 • n=2008 Participants
|
|
Pain duration (years from first occurrence)
|
11.8 years
STANDARD_DEVIATION 9.7 • n=1000 Participants
|
11.1 years
STANDARD_DEVIATION 7.5 • n=1986 Participants
|
11.4 years
STANDARD_DEVIATION 8.7 • n=2008 Participants
|
|
Percent of Days with low back pain (LBP) in the last 12 months
|
95 % of days
STANDARD_DEVIATION 13 • n=1000 Participants
|
97 % of days
STANDARD_DEVIATION 8 • n=1986 Participants
|
96 % of days
STANDARD_DEVIATION 11 • n=2008 Participants
|
|
Leg pain
|
31 Participants
n=1000 Participants
|
28 Participants
n=1986 Participants
|
59 Participants
n=2008 Participants
|
|
LBP NRS
|
7.1 units on a scale
STANDARD_DEVIATION 0.8 • n=1000 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 0.9 • n=1986 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 0.9 • n=2008 Participants
|
|
EQ-5D-5L index score
|
0.626 units on a scale
STANDARD_DEVIATION 0.116 • n=1000 Participants
|
0.612 units on a scale
STANDARD_DEVIATION 0.125 • n=1986 Participants
|
0.619 units on a scale
STANDARD_DEVIATION 0.120 • n=2008 Participants
|
|
ODI
|
44 units on a scale
STANDARD_DEVIATION 8 • n=1000 Participants
|
44 units on a scale
STANDARD_DEVIATION 8 • n=1986 Participants
|
44 units on a scale
STANDARD_DEVIATION 8 • n=2008 Participants
|
PRIMARY outcome
Timeframe: 1 yearComparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data. ODI is measured on a scale of 0 to 100 where a lower score is a better outcome.
Outcome measures
| Measure |
Treatment (ReActiv8)
n=99 Participants
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
n=104 Participants
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year
|
|---|---|---|
|
Change in Oswestry Disability Index (ODI)
|
-19.7 units on a scale
Standard Deviation 1.4
|
-2.9 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 1 yearComparison of 1-year change from baseline in LBP NRS between Treatment and Control with MMRM for missing data. NRS is measured on a scale of 0 to 10 where a higher score is a better outcome.
Outcome measures
| Measure |
Treatment (ReActiv8)
n=99 Participants
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
n=104 Participants
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year
|
|---|---|---|
|
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
|
-3.6 score on a scale
Standard Deviation 0.2
|
-0.6 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 1 yearComparison of 1-year change from baseline in EQ-5D between Treatment and Control with MMRM for missing data. EQ-5D is measured on a scale of -0.5 to 1.0 where a higher score is a better outcome.
Outcome measures
| Measure |
Treatment (ReActiv8)
n=99 Participants
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
n=104 Participants
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year
|
|---|---|---|
|
Change in EQ-5D
|
0.155 score on a scale
Standard Deviation 0.012
|
0.008 score on a scale
Standard Deviation 0.012
|
Adverse Events
Treatment (ReActiv8)
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Control (OMM)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (ReActiv8)
n=99 participants at risk
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
n=104 participants at risk
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year
|
|---|---|---|
|
Surgical and medical procedures
Appendectomy
|
1.0%
1/99 • Number of events 1 • 1 year
|
0.00%
0/104 • 1 year
|
|
Nervous system disorders
Aseptic Meningitis
|
0.00%
0/99 • 1 year
|
0.96%
1/104 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hemorrhagic stroke
|
1.0%
1/99 • Number of events 1 • 1 year
|
0.00%
0/104 • 1 year
|
|
Eye disorders
Ophthalmic herpes zoster
|
1.0%
1/99 • Number of events 1 • 1 year
|
0.00%
0/104 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/99 • Number of events 1 • 1 year
|
0.00%
0/104 • 1 year
|
|
Infections and infestations
Pocket infection
|
1.0%
1/99 • Number of events 1 • 1 year
|
0.00%
0/104 • 1 year
|
|
Infections and infestations
Wound infection
|
1.0%
1/99 • Number of events 1 • 1 year
|
0.00%
0/104 • 1 year
|
|
Nervous system disorders
Aneurysm cerebral
|
1.0%
1/99 • Number of events 1 • 1 year
|
0.00%
0/104 • 1 year
|
Other adverse events
| Measure |
Treatment (ReActiv8)
n=99 participants at risk
Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year
Stimulation frequency: 20 Hz
|
Control (OMM)
n=104 participants at risk
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year
|
|---|---|---|
|
Surgical and medical procedures
Implant site pocket pain
|
8.1%
8/99 • Number of events 9 • 1 year
|
0.00%
0/104 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
10.1%
10/99 • Number of events 10 • 1 year
|
9.6%
10/104 • Number of events 11 • 1 year
|
|
Product Issues
Device overstimulation of tissue
|
5.1%
5/99 • Number of events 5 • 1 year
|
0.00%
0/104 • 1 year
|
Additional Information
Jennifer Tinsley, Director of Clinical Affairs
Mainstay Medical
Phone: (877) 702-8488
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place