Clinical trial NCT02577354: ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
Official title: ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Mainstay Medical
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 204
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Responder Rate of Low Back Pain With No Increase in Pain Medications
timeFrame: 120 Days
measure: Mean Change in Low Back Pain VAS
timeFrame: 120 Days
measure: Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels
timeFrame: 120 Days
measure: Serious Device and/or Procedure Related Adverse Event Rate
timeFrame: 120 Days
Secondary outcomes:
measure: Change in Oswestry Disability Index (ODI)
timeFrame: 120 Days
measure: Change in European Quality of Life Score on Five Dimensions (EQ-5D)
timeFrame: 120 Days
measure: Change in Percent Pain Relief (PPR)
timeFrame: 120 Days
measure: Subject Global Impression of Change (SGIC)
timeFrame: 120 Days
measure: Resolution of Back Pain (VAS ≤2.5 cm)
timeFrame: 120 Days
measure: LBP VAS Responder Rate at One Year
timeFrame: 1 Year
measure: Mean Change in LBP VAS at One Year
timeFrame: 1 Year
measure: Change in Oswestry Disability Index (ODI) at One Year
timeFrame: 1 Year
measure: Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year
timeFrame: 1 Year
measure: Percent Pain Relief at One Year
timeFrame: 1 Year
measure: Subject Global Impression of Change (SGIC) at One Year
timeFrame: 1 Year
measure: Resolution of Back Pain at One Year
timeFrame: 1 Year
Other outcomes:
measure: Supplementary Analysis of Primary Endpoint: Responder Rate of Low Back Pain With No Increase in Low Back Pain Medications
timeFrame: 120 Days
measure: Treatment Satisfaction
timeFrame: 120 Days
measure: Treatment Satisfaction at One Year
timeFrame: 1 Year
measure: Clinical Global Impression of Change
timeFrame: 120 Days
measure: Clinical Global Impression of Change at One Year
timeFrame: 1 Year
measure: Change in Opioid Use for Treatment of Low Back Pain at One-Year
timeFrame: 1 Year
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Santa Monica
country: United States
facility: The Spine Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Spartanburg
country: United States
facility: Upstate Clinical Trials
state: South Carolina
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists
state: Washington
city: Charleston
country: United States
facility: Center for Pain Relief
state: West Virginia
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Noosa Heads
country: Australia
facility: Sunshine Coast Clinical Research
state: Queensland
city: Welland
country: Australia
facility: Pain Medicine of South Australia
state: South Australia
city: Clayton
country: Australia
facility: Monash Clinical Research
state: Victoria
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Wilrijk
country: Belgium
facility: Sint Augustinus
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Medical Center
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
Study officials:
affiliation: Brigham and Women's Hospital
name: Chris Gilligan, MD, MBA
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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, 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.