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ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577354
Recruitment Status : Active, not recruiting
First Posted : October 16, 2015
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Mainstay Medical

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation) Device: ReActiv8 Implantable Stimulation System (Low Stimulation) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
Study Start Date : August 2016
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Device: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)
ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.
Experimental: Control Device: ReActiv8 Implantable Stimulation System (Low Stimulation)
ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.


Outcome Measures
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Primary Outcome Measures :
  1. Responder Rate of Low Back Pain With No Increase in Pain Medications [ Time Frame: 120 Days ]

    Comparison of responder rates for low back pain VAS between Treatment and Control groups.

    The Primary Efficacy Endpoint is a comparison of responder rates between Treatment and Control groups, where a "responder" is a participant with ≥30% reduction from baseline in average low back pain VAS, without any increase from baseline in pain medications and/or muscle relaxants for any reason including non low back pain reasons.

    The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, where zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain.

    Any increase in dosage of a pain medication or any new pain medication taken for any reason counts as an increase in medications.


  2. Mean Change in Low Back Pain VAS [ Time Frame: 120 Days ]

    Comparison of change in LBP VAS (120 days from baseline) between the Treatment and Control groups. The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, where zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain.

    A change to a lower score (negative value) indicates improvement.


  3. Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels [ Time Frame: 120 Days ]
    The CPRA, which was prespecified in the clinical protocol and statistical analysis plan prior to the start of the trial, was performed using the same data as used for the primary endpoint analysis and was included as part of the primary endpoint analysis

  4. Serious Device and/or Procedure Related Adverse Event Rate [ Time Frame: 120 Days ]

    The primary safety assessment is of serious device and/or procedure related adverse events in all participants at 120 days.

    The 8 events reported below are 6 implant site pocket infections, 1 intra-operative upper airway obstruction, and 1 non-radicular, focal numbness on the surface of the thigh.



Secondary Outcome Measures :
  1. Change in Oswestry Disability Index (ODI) [ Time Frame: 120 Days ]

    Comparison of change in ODI (120 days from baseline) between Treatment and Control groups. ODI is reported as a score from 0 to 100%, where 0%-20% indicates minimal disability, 21%-40% indicates moderate disability, 41%-60% indicates severe disability, 61%-80% indicates crippled, and 81%-100% indicates bedbound or an exaggeration of symptoms.

    A change to a lower score (negative value) indicates improvement.


  2. Change in European Quality of Life Score on Five Dimensions (EQ-5D) [ Time Frame: 120 Days ]

    Comparison of change in EQ-5D (120 days from baseline) between Treatment and Control groups. The EQ-5D Index is scored on a scale of -0.594 to 1.00, with a score of 1.00 indicating full health.

    A change to a higher score (positive value) indicates improvement.


  3. Change in Percent Pain Relief (PPR) [ Time Frame: 120 Days ]
    PPR is a patient-reported percent of pain relief at 120 days compared to the pain at baseline, where 0% indicates no pain relief compared to baseline, and 100% indicates complete pain relief compared to baseline.

  4. Subject Global Impression of Change (SGIC) [ Time Frame: 120 Days ]
    A questionnaire completed with the following item: Since I enrolled in the study, my overall status is 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse

  5. Resolution of Back Pain (VAS ≤2.5 cm) [ Time Frame: 120 Days ]
    Resolution of back pain (remitter rate) was defined as a participant with 7-day average low back pain VAS ≤2.5 cm on the 10 cm VAS.

  6. LBP VAS Responder Rate at One Year [ Time Frame: 1 Year ]

    A "responder" is a participant with ≥30% reduction from baseline in average low back pain VAS, without any increase from baseline in pain medications and/or muscle relaxants for any reason including non low back pain reasons.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.


  7. Mean Change in LBP VAS at One Year [ Time Frame: 1 Year ]

    Change in LBP VAS at 1 year compared to baseline. The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, one for each symptom extreme for Low Back Pain. Zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.

    A change to a lower score (negative value) indicates improvement.


  8. Change in Oswestry Disability Index (ODI) at One Year [ Time Frame: 1 Year ]

    Change in ODI at 1 year compared to baseline. ODI is reported as a score from 0 to 100%, where 0%-20% indicates minimal disability, 21%-40% indicates moderate disability, 41%-60% indicates severe disability, 61%-80% indicates crippled, and 81%-100% indicates bedbound or an exaggeration of symptoms.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.

    A change to a lower score (negative value) indicates improvement.


  9. Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year [ Time Frame: 1 Year ]

    Change in EQ-5D at 1 year compared to baseline. The EQ-5D Index is scored on a scale of -0.594 to 1.00, with a score of 1.00 indicating full health.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.

    A change to a higher score (positive value) indicates improvement.


  10. Percent Pain Relief at One Year [ Time Frame: 1 Year ]

    PPR is a patient-reported percent of pain relief compared to the pain at baseline, where 0% indicates no pain relief compared to baseline, and 100% indicates complete pain relief compared to baseline.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.


  11. Subject Global Impression of Change (SGIC) at One Year [ Time Frame: 1 Year ]

    A questionnaire with the following item: Since I enrolled in the study, my overall status is 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.


  12. Resolution of Back Pain at One Year [ Time Frame: 1 Year ]

    Resolution of back pain (remitter rate) was defined as a participant with 7-day average low back pain VAS ≤2.5 cm on the 10 cm VAS.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.



Other Outcome Measures:
  1. Supplementary Analysis of Primary Endpoint: Responder Rate of Low Back Pain With No Increase in Low Back Pain Medications [ Time Frame: 120 Days ]

    This pre-specified analysis of the primary endpoint examines the impact of rescue medications taken for acute pain conditions for reasons other than low back pain, by excluding those participants from the analysis who took rescue medications for reasons other than low back pain.

    Nine participants in both groups increased pain medications. In the control group, all nine participants increased pain medications due to low back pain. In the treatment group, three of the nine participants increased pain medications due to low back pain, while six of the nine participants increased pain medications for reasons other than low back pain. Since any increase in pain medications automatically considers a participant a non-responder, these six participants are removed from this analysis to eliminate the confounding factor of increases in pain medications for reasons other than low back pain.


  2. Treatment Satisfaction [ Time Frame: 120 Days ]
    The Treatment Satisfaction Questionnaire asking the participant if they are satisfied with the treatment.

  3. Treatment Satisfaction at One Year [ Time Frame: 1 Year ]

    The Treatment Satisfaction Questionnaire asking the participant if they are satisfied with the outcome of the treatment.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.


  4. Clinical Global Impression of Change [ Time Frame: 120 Days ]
    Clinical Global Impression consists of the following question completed by the Investigator prior to unblinding: In your opinion as a clinician, compared to the patient's situation at baseline, would you say the patient is: 1) Much better, 2) Slightly better, 3) About the same, 4) Slightly worse, 5) Much worse.

  5. Clinical Global Impression of Change at One Year [ Time Frame: 1 Year ]

    Clinical Global Impression consists of the following question completed by the Investigator prior to unblinding: In your opinion as a clinician, compared to the patient's situation at baseline, would you say the patient is: 1) Much better, 2) Slightly better, 3) About the same, 4) Slightly worse, 5) Much worse.

    After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.


  6. Change in Opioid Use for Treatment of Low Back Pain at One-Year [ Time Frame: 1 Year ]
    Any increase or decrease of dosage or frequency of an opioid taken for the treatment of low back pain was considered a change.


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥22 years, ≤75 years
  2. Chronic Low Back Pain that has persisted >90 days prior to the baseline visit.
  3. Continuing low back pain despite >90 days of medical management.
  4. Qualifying pain score.
  5. Qualifying disability score.
  6. Evidence of lumbar multifidus muscle dysfunction.
  7. Be willing and capable of giving Informed Consent.
  8. Ability to comply with the instructions for use and to operate ReActiv8, and to comply with this Clinical Investigation Plan.
  9. Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.

Exclusion Criteria:

  1. BMI > 35

  2. Back Pain characteristics:

    1. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
    2. Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in subjects with lower extremity pain.
    3. Neurological deficit possibly associated with the back pain (e.g. foot drop).
    4. Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
    5. Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia).
    6. Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amenable to surgery.
    7. Back pain due to vascular causes such as aortic aneurysm and dissection.
  3. Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
  4. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
  5. Source of pain is the sacroiliac joint as determined by the Investigator.
  6. Drug use.
  7. Surgical and other procedures exclusions.
  8. Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion that is amenable to surgery.
  9. Planned surgery.
  10. Co-morbid chronic pain conditions.
  11. Other clinical conditions.
  12. Psycho-social exclusions.
  13. Protocol compliance exclusions.
  14. General exclusions.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577354


Locations
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Sponsors and Collaborators
Mainstay Medical
Investigators
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Study Chair: Chris Gilligan, MD, MBA Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Mainstay Medical:
Study Protocol  [PDF] March 25, 2017
Statistical Analysis Plan  [PDF] December 10, 2015

More Information
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Responsible Party: Mainstay Medical
ClinicalTrials.gov Identifier: NCT02577354    
Other Study ID Numbers: 950057
First Posted: October 16, 2015    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations