N/A
Completed N=204
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
Source: ClinicalTrials.gov NCT02577354 ↗Enrolled (actual)
204
Serious AEs
3.7%
Results posted
Oct 2020
Primary outcomePrimary: Responder Rate of Low Back Pain With No Increase in Pain Medications — 57.1; 46.6 percentage of responsers — p=0.138
Summary
The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate of Low Back Pain With No Increase in Pain Medications |
57.1; 46.6 | 0.138 |
| PRIMARY Mean Change in Low Back Pain VAS |
-3.3; -2.4 | 0.032 sig |
| PRIMARY Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels |
83.0; 71.3; 78.0; 63.4; 68.0; 50.5 | 0.0499 sig |
| PRIMARY Serious Device and/or Procedure Related Adverse Event Rate |
3; 5 | — |
| SECONDARY Change in Oswestry Disability Index (ODI) |
-17.5; -12.2 | 0.011 sig |
| SECONDARY Change in European Quality of Life Score on Five Dimensions (EQ-5D) |
0.186; 0.115 | 0.009 sig |
| SECONDARY Change in Percent Pain Relief (PPR) |
52; 35 | <0.001 sig |
| SECONDARY Subject Global Impression of Change (SGIC) |
32; 18; 22; 16; 25; 29 | 0.003 sig |
| SECONDARY Resolution of Back Pain (VAS ≤2.5 cm) |
34; 28 | 0.335 |
| SECONDARY LBP VAS Responder Rate at One Year |
58; 57; 115 | — |
| SECONDARY Mean Change in LBP VAS at One Year |
-4.2; -4.3; -4.3 | — |
| SECONDARY Change in Oswestry Disability Index (ODI) at One Year |
-20.1; -19.8; -19.9 | — |
| SECONDARY Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year |
0.210; 0.187; 0.198 | — |
| SECONDARY Percent Pain Relief at One Year |
65; 66; 66 | — |
| SECONDARY Subject Global Impression of Change (SGIC) at One Year |
44; 40; 84; 19; 23; 42 | — |
| SECONDARY Resolution of Back Pain at One Year |
42; 49; 91 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥22 years, ≤75 years
- Chronic Low Back Pain that has persisted >90 days prior to the baseline visit.
- Continuing low back pain despite >90 days of medical management.
- Qualifying pain score.
- Qualifying disability score.
- Evidence of lumbar multifidus muscle dysfunction.
- Be willing and capable of giving Informed Consent.
- Ability to comply with the instructions for use and to operate ReActiv8, and to comply with this Clinical Investigation Plan.
- Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
Exclusion Criteria
- BMI > 35
- Back Pain characteristics:
- Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
- Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in subjects with lower extremity pain.
- Neurological deficit possibly associated with the back pain (e.g. foot drop).
- Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
- Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia).
- Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amenable to surgery.
- Back pain due to vascular causes such as aortic aneurysm and dissection.
- Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
- Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
- Source of pain is the sacroiliac joint as determined by the Investigator.
- Drug use.
- Surgical and other procedures exclusions.
- Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion that is amenable to surgery.
- Planned surgery.
- Co-morbid chronic pain conditions.
- Other clinical conditions.
- Psycho-social exclusions.
- Protocol compliance exclusions.
- General exclusions.
Data sourced from ClinicalTrials.gov (NCT02577354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.