Chronic Low Back PainReActiv8-BNCT02577354

ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

A study testing ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation) and ReActiv8 Implantable Stimulation System (Low Stimulation) in people with Chronic Low Back Pain, run by Mainstay Medical at 26 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 to 75 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation) and ReActiv8 Implantable Stimulation System (Low Stimulation)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 26 sitesin 5 countries
Study dates: Aug 2016to Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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).

Show all 21Show fewer

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.

Trial locations and contacts

26 sites in 5 countries.

Country

City, postcode or hospital

26 sites in 5 countries

United States16 sites

University of Colorado Hospital
Aurora, Colorado
The Brigham and Women's Hospital
Boston, Massachusetts
Indiana Spine Group
Carmel, Indiana
Center for Pain Relief
Charleston, West Virginia
Louis Stokes VA Medical Center
Cleveland, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio
Duke University Medical Center
Durham, North Carolina
OrthoIndy
Indianapolis, Indiana
University of Kansas Medical Center
Kansas City, Kansas
University of California, San Diego
La Jolla, California
Rhode Island Hospital
Providence, Rhode Island
Beaumont Health
Royal Oak, Michigan
The Spine Institute
Santa Monica, California
Upstate Clinical Trials
Spartanburg, South Carolina
Northwest Orthopaedic Specialists
Spokane, Washington
Center for Clinical Research
Winston-Salem, North Carolina

Other trials in United States

Australia4 sites

Genesis Research Services
Broadmeadow, New South Wales
Monash Clinical Research
Clayton, Victoria
Sunshine Coast Clinical Research
Noosa, Queensland
Pain Medicine of South Australia
Welland, South Australia

Other trials in Australia

United Kingdom3 sites

Seacroft Hospital
Leeds
St. Bartholomew's Hospital
London
The James Cook University Hospital
Middlesbrough

Other trials in United Kingdom

Belgium2 sites

AZ Nikolaas
Sint-Niklaas
Sint Augustinus
Wilrijk

Other trials in Belgium

Netherlands1 site

Erasmus MC University Medical Center
Rotterdam

Other trials in Netherlands

About this study

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

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.

Conditions: Chronic Low Back Pain
Being tested: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation), ReActiv8 Implantable Stimulation System (Low Stimulation)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)Device
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.
ReActiv8 Implantable Stimulation System (Low Stimulation)Device
ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.

Study groups in NCT02577354
Study group	Role	What they receive
Treatment	Experimental	Not described Receives: Device: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)
Control	Experimental	Not described Receives: Device: ReActiv8 Implantable Stimulation System (Low Stimulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 120 Days
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.
Measured: 120 Days
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
Measured: 120 Days
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.
Measured: 120 Days

Secondary outcomes (12)

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.
Measured: 120 Days
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.
Measured: 120 Days
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.
Measured: 120 Days
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
Measured: 120 Days
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.
Measured: 120 Days
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Jan 2024

First posted16 Oct 2015 (estimated)
Study startAug 2016
Primary completionNov 2018
Study completionJan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02577354
Sponsor's protocol ID: 950057
Acronym: ReActiv8-B
Status last verified: Feb 2025
First submitted: 12 Oct 2015
Last updated: 27 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gilligan C, Burnside D, Grant L, Yong RJ, Mullins PM, Schwab F, Mekhail N. ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol). Pain Ther. 2023 Apr;12(2):607-620. doi: 10.1007/s40122-023-00475-4. Epub 2023 Feb 14.
PubMed 36787013
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.
PubMed 34534176
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.
PubMed 35088722
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.
PubMed 36175320
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, Maislin G, Heemels JP, Eldabe S. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024 Jul;27(5):930-943. doi: 10.1016/j.neurom.2024.01.006. Epub 2024 Mar 12.
PubMed 38483366
Shaffrey C, Gilligan C. Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact. Neurosurgery. 2023 Apr 1;92(4):716-724. doi: 10.1227/neu.0000000000002305. Epub 2023 Feb 14.
PubMed 36786565

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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RecruitingPhase 2
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Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
ClinicalTrials.gov ID: NCT02577354
Acronym / sponsor ID: ReActiv8-B / 950057
Conditions: Chronic Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Mainstay MedicalIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: Nov 2018 (actual)
Study completion: Jan 2024 (actual)
First posted: 16 Oct 2015 (estimated)
Results: Posted 19 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Device: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)
Control	Experimental	Device: ReActiv8 Implantable Stimulation System (Low Stimulation)

Who may qualify

Ages: 22 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (21 listed)

BMI > 35
Back Pain characteristics:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Treatment
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.	Device	Control

Primary outcome

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.
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.
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
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.

12 secondary outcomes

Change in Oswestry Disability Index (ODI)
Time frame: 120 Days
Change in European Quality of Life Score on Five Dimensions (EQ-5D)
Time frame: 120 Days
Change in Percent Pain Relief (PPR)
Time frame: 120 Days
Subject Global Impression of Change (SGIC)
Time frame: 120 Days
Resolution of Back Pain (VAS ≤2.5 cm)
Time frame: 120 Days
LBP VAS Responder Rate at One Year
Time frame: 1 Year
Mean Change in LBP VAS at One Year
Time frame: 1 Year
Change in Oswestry Disability Index (ODI) at One Year
Time frame: 1 Year
Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year
Time frame: 1 Year
Percent Pain Relief at One Year
Time frame: 1 Year
Subject Global Impression of Change (SGIC) at One Year
Time frame: 1 Year
Resolution of Back Pain at One Year
Time frame: 1 Year

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	102	87
Control/Crossover	102	89

Primary outcome: Responder Rate of Low Back Pain With No Increase in Pain Medications

Time frame: 120 Days. Number. Unit: percentage of responsers

Measure	Treatment n = 102	Control n = 102
Value	57.1	46.6

Treatment vs Control: p = 0.138, Wald asymptotic test of proportions

Population analysed: 100 treatment group participants and 101 control group participants returned for the 120 day visit. Results for the 3 participants lost to follow-up were included using multiple imputation.

Primary outcome: Mean Change in Low Back Pain VAS

Time frame: 120 Days. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment n = 100	Control n = 101
Value	-3.3 (2.7)	-2.4 (2.9)

Treatment vs Control: p = 0.032, t-test, 2 sided

Primary outcome: 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. Number. Unit: percentage of participants

Measure	Treatment n = 102	Control n = 102
>0% Reduction in Pain	83.0	71.3
>10% Reduction in Pain	78.0	63.4
>20% Reduction in Pain	68.0	50.5
>30% Reduction in Pain	57.0	46.5
>40% Reduction in Pain	51.0	39.6
>50% Reduction in Pain	42.0	33.7
>60% Reduction in Pain	36.0	30.7
>70% Reduction in Pain	28.0	24.8

Treatment vs Control: p = 0.0499, Friedman's regression analysis

Population analysed: 3 participants lost to follow-up included using multiple imputation.

Primary outcome: Serious Device and/or Procedure Related Adverse Event Rate

Time frame: 120 Days. Count of participants. Unit: Participants

Measure	Treatment n = 102	Control n = 102
Value	3	5

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events were collected through the 120 day primary endpoint and through one year per the Investigational Device Exemption (IDE). The FDA required a minimum of 150 participants through one year prior to Premarket Approval (PMA) application. These results are adverse events (related and unrelated) reported through the one year visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment -- Blinded Phase (0-120 Days)	4 of 102 (3.9%)	32 of 102 (31.4%)	0 of 102
Control -- Blinded Phase (0-120 Days)	6 of 102 (5.9%)	24 of 102 (23.5%)	0 of 102
Treatment -- Open Label Phase (121-365 Days)	3 of 99 (3%)	25 of 99 (25.3%)	0 of 99
Crossover -- Open Label Phase (121-365 Days)	2 of 99 (2%)	34 of 99 (34.3%)	0 of 99

Limitations and caveats (from the sponsor): Dichotomization of primary endpoint reduced statistical power by losing information on exact response magnitude. This limitation is addressed by the cumulative proportion of responders analysis of the primary endpoint data (Outcome Measure #3).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36787013Gilligan C, Burnside D, Grant L, Yong RJ, Mullins PM, Schwab F, Mekhail N. ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol). Pain Ther. 2023 Apr;12(2):607-620. doi: 10.1007/s40122-023-00475-4. Epub 2023 Feb 14.
Results publication: PubMed 34534176Gilligan 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 publication: PubMed 35088722Gilligan 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 publication: PubMed 36175320Gilligan 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.
Results publication: PubMed 38483366Gilligan 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, Maislin G, Heemels JP, Eldabe S. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024 Jul;27(5):930-943. doi: 10.1016/j.neurom.2024.01.006. Epub 2024 Mar 12.
Derived from this study: PubMed 36786565Shaffrey C, Gilligan C. Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact. Neurosurgery. 2023 Apr 1;92(4):716-724. doi: 10.1227/neu.0000000000002305. Epub 2023 Feb 14.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris Gilligan, MD, MBA study chair

Brigham and Women's Hospital

26 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Australia, United Kingdom, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder Rate of Low Back Pain With No Increase in Pain Medications (time frame: 120 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02577354, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.