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

Primary Purpose

Chronic Low Back Pain

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)
ReActiv8 Implantable Stimulation System (Low Stimulation)
Sponsored by
Mainstay Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Diego
  • The Spine Institute
  • University of Colorado Hospital
  • Indiana Spine Group
  • OrthoIndy
  • University of Kansas Medical Center
  • The Brigham and Women's Hospital
  • Beaumont Health
  • Duke University Medical Center
  • Center for Clinical Research
  • Louis Stokes VA Medical Center
  • University Hospitals Cleveland Medical Center
  • Rhode Island Hospital
  • Upstate Clinical Trials
  • Northwest Orthopaedic Specialists
  • Center for Pain Relief
  • Genesis Research Services
  • Sunshine Coast Clinical Research
  • Pain Medicine of South Australia
  • Monash Clinical Research
  • AZ Nikolaas
  • Sint Augustinus
  • Erasmus MC University Medical Center
  • Seacroft Hospital
  • St. Bartholomew's Hospital
  • The James Cook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment

Control

Arm Description

Outcomes

Primary Outcome Measures

Responder Rate of Low Back Pain With No Increase in Pain Medications
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.
Mean Change in Low Back Pain VAS
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.
Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels
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
Serious Device and/or Procedure Related Adverse Event Rate
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

Change in Oswestry Disability Index (ODI)
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.
Change in European Quality of Life Score on Five Dimensions (EQ-5D)
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.
Change in Percent Pain Relief (PPR)
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.
Subject Global Impression of Change (SGIC)
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
Resolution of Back Pain (VAS ≤2.5 cm)
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.
LBP VAS Responder Rate at One 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.
Mean Change in LBP VAS at One 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.
Change in Oswestry Disability Index (ODI) at One 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.
Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One 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.
Percent Pain Relief at One 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.
Subject Global Impression of Change (SGIC) at One 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.
Resolution of Back Pain at One 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.

Full Information

First Posted
October 12, 2015
Last Updated
March 13, 2023
Sponsor
Mainstay Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02577354
Brief Title
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
Acronym
ReActiv8-B
Official Title
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mainstay Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ReActiv8 Implantable Stimulation System (Low Stimulation)
Intervention Description
ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.
Primary Outcome Measure Information:
Title
Responder Rate of Low Back Pain With No Increase in Pain Medications
Description
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.
Time Frame
120 Days
Title
Mean Change in Low Back Pain VAS
Description
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.
Time Frame
120 Days
Title
Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels
Description
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
Time Frame
120 Days
Title
Serious Device and/or Procedure Related Adverse Event Rate
Description
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.
Time Frame
120 Days
Secondary Outcome Measure Information:
Title
Change in Oswestry Disability Index (ODI)
Description
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.
Time Frame
120 Days
Title
Change in European Quality of Life Score on Five Dimensions (EQ-5D)
Description
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.
Time Frame
120 Days
Title
Change in Percent Pain Relief (PPR)
Description
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.
Time Frame
120 Days
Title
Subject Global Impression of Change (SGIC)
Description
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
Time Frame
120 Days
Title
Resolution of Back Pain (VAS ≤2.5 cm)
Description
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.
Time Frame
120 Days
Title
LBP VAS Responder Rate at One Year
Description
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.
Time Frame
1 Year
Title
Mean Change in LBP VAS at One Year
Description
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.
Time Frame
1 Year
Title
Change in Oswestry Disability Index (ODI) at One Year
Description
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.
Time Frame
1 Year
Title
Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year
Description
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.
Time Frame
1 Year
Title
Percent Pain Relief at One Year
Description
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.
Time Frame
1 Year
Title
Subject Global Impression of Change (SGIC) at One Year
Description
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.
Time Frame
1 Year
Title
Resolution of Back Pain at One Year
Description
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.
Time Frame
1 Year
Other Pre-specified Outcome Measures:
Title
Supplementary Analysis of Primary Endpoint: Responder Rate of Low Back Pain With No Increase in Low Back Pain Medications
Description
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.
Time Frame
120 Days
Title
Treatment Satisfaction
Description
The Treatment Satisfaction Questionnaire asking the participant if they are satisfied with the treatment.
Time Frame
120 Days
Title
Treatment Satisfaction at One Year
Description
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.
Time Frame
1 Year
Title
Clinical Global Impression of Change
Description
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.
Time Frame
120 Days
Title
Clinical Global Impression of Change at One Year
Description
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.
Time Frame
1 Year
Title
Change in Opioid Use for Treatment of Low Back Pain at One-Year
Description
Any increase or decrease of dosage or frequency of an opioid taken for the treatment of low back pain was considered a change.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Gilligan, MD, MBA
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
Country
United States
Facility Name
The Spine Institute
City
Santa Monica
State/Province
California
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
Country
United States
Facility Name
OrthoIndy
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
The Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Beaumont Health
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Louis Stokes VA Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Upstate Clinical Trials
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Northwest Orthopaedic Specialists
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Center for Pain Relief
City
Charleston
State/Province
West Virginia
Country
United States
Facility Name
Genesis Research Services
City
Broadmeadow
State/Province
New South Wales
Country
Australia
Facility Name
Sunshine Coast Clinical Research
City
Noosa Heads
State/Province
Queensland
Country
Australia
Facility Name
Pain Medicine of South Australia
City
Welland
State/Province
South Australia
Country
Australia
Facility Name
Monash Clinical Research
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
AZ Nikolaas
City
Sint-Niklaas
Country
Belgium
Facility Name
Sint Augustinus
City
Wilrijk
Country
Belgium
Facility Name
Erasmus MC University Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Seacroft Hospital
City
Leeds
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
The James Cook University Hospital
City
Middlesbrough
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36175320
Citation
Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Sayed D, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Schwab F, Maislin G, Heemels JP, Eldabe S. Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction. Neuromodulation. 2023 Jan;26(1):98-108. doi: 10.1016/j.neurom.2022.08.457. Epub 2022 Sep 27. Erratum In: Neuromodulation. 2023 Aug;26(6):1272-1273.
Results Reference
derived
PubMed Identifier
35088722
Citation
Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Maislin G, Heemels JP, Eldabe S; ReActiv8-B Investigators. Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial. Neuromodulation. 2023 Jan;26(1):87-97. doi: 10.1016/j.neurom.2021.10.011. Epub 2021 Dec 18.
Results Reference
derived
PubMed Identifier
34534176
Citation
Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Levy R, Heemels JP, Eldabe S; ReActiv8-B investigators. An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain. 2021 Oct 1;162(10):2486-2498. doi: 10.1097/j.pain.0000000000002258.
Results Reference
derived

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ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

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