Chronic Low-back Pain
Conditions
Keywords
Neurostimulation, Stimulation, Multifidus, Restorative neurostimulation, Multifidus muscle control, Neurostimulator
Brief summary
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
Detailed description
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control group).
Interventions
DEVICEReActiv8
Market-approved ReActiv8 device implanted
Sponsors
Mainstay Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥21 years 2. Evidence of lumbar multifidus muscle dysfunction 3. Intractable Chronic Low Back Pain that has persisted \>6 months resulting in pain most of the days in the past 12 months 4. Failed therapy including pain medications and physical therapy 5. Not a candidate for spine surgery 6. Low Back Pain NRS of ≥6 and ≤9 7. Oswestry Disability Index score ≥30 and ≤60 8. Willing and capable of giving Informed Consent 9. Able to comply with this protocol 10. On Optimal Medical Management per the Investigator
Exclusion criteria
1. Contraindicated for the ReActiv8 System 2. BMI \> 35 3. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis 4. An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery 5. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee 6. Any condition unrelated to CLBP which, in the opinion of the Investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy 7. Surgical and other procedure exclusions 8. Psycho-social exclusions 9. Protocol compliance exclusions 10. General exclusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low Back Pain Numerical Rating Scale (LBP NRS) | 1 year | Comparison 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. |
| Change in EQ-5D | 1 year | Comparison 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. |
Countries
United States
Contacts
STUDY_CHAIRFrank Schwab
New York-Presbyterian
STUDY_CHAIRChris Gilligan
Brigham and Women's Hospital
STUDY_CHAIRKiran Patel
Northwell Health
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 99 |
| 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 | 104 |
| Total | 203 |
Baseline characteristics
| Characteristic | Treatment (ReActiv8) | Control (OMM) | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 11 | 48 years STANDARD_DEVIATION 13 | 47 years STANDARD_DEVIATION 12 |
| Body Mass Index (BMI) | 29 kg/m^2 STANDARD_DEVIATION 4 | 28 kg/m^2 STANDARD_DEVIATION 4 | 29 kg/m^2 STANDARD_DEVIATION 4 |
| EQ-5D-5L index score | 0.626 units on a scale STANDARD_DEVIATION 0.116 | 0.612 units on a scale STANDARD_DEVIATION 0.125 | 0.619 units on a scale STANDARD_DEVIATION 0.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants | 100 Participants | 195 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| LBP NRS | 7.1 units on a scale STANDARD_DEVIATION 0.8 | 7.1 units on a scale STANDARD_DEVIATION 0.9 | 7.1 units on a scale STANDARD_DEVIATION 0.9 |
| Leg pain | 31 Participants | 28 Participants | 59 Participants |
| ODI | 44 units on a scale STANDARD_DEVIATION 8 | 44 units on a scale STANDARD_DEVIATION 8 | 44 units on a scale STANDARD_DEVIATION 8 |
| Pain duration (years from first occurrence) | 11.8 years STANDARD_DEVIATION 9.7 | 11.1 years STANDARD_DEVIATION 7.5 | 11.4 years STANDARD_DEVIATION 8.7 |
| Percent of Days with low back pain (LBP) in the last 12 months | 95 % of days STANDARD_DEVIATION 13 | 97 % of days STANDARD_DEVIATION 8 | 96 % of days STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 92 Participants | 97 Participants | 189 Participants |
| Region of Enrollment United States | 99 participants | 104 participants | 203 participants |
| Sex: Female, Male Female | 58 Participants | 68 Participants | 126 Participants |
| Sex: Female, Male Male | 41 Participants | 36 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 104 |
| other Total, other adverse events | 22 / 99 | 10 / 104 |
| serious Total, serious adverse events | 7 / 99 | 1 / 104 |
Outcome results
Primary
Change in Oswestry Disability Index (ODI)
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (ReActiv8) | Change in Oswestry Disability Index (ODI) | -19.7 units on a scale | Standard Deviation 1.4 |
| Control (OMM) | Change in Oswestry Disability Index (ODI) | -2.9 units on a scale | Standard Deviation 1.4 |
p-value: <0.001t-test, 2 sided
Secondary
Change in EQ-5D
Comparison 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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (ReActiv8) | Change in EQ-5D | 0.155 score on a scale | Standard Deviation 0.012 |
| Control (OMM) | Change in EQ-5D | 0.008 score on a scale | Standard Deviation 0.012 |
p-value: <0.001t-test, 2 sided
Secondary
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
Comparison 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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (ReActiv8) | Change in Low Back Pain Numerical Rating Scale (LBP NRS) | -3.6 score on a scale | Standard Deviation 0.2 |
| Control (OMM) | Change in Low Back Pain Numerical Rating Scale (LBP NRS) | -0.6 score on a scale | Standard Deviation 0.2 |
p-value: <0.001t-test, 2 sided