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ReActiv8 for Chronic Low Back Pain (PMCF) (ReActiv8-A)

Primary Purpose

Chronic Low Back Pain

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ReActiv8 Implantable Stimulation System implanted and activated.
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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years, ≤65 years
  2. Chronic Low Back Pain with a first occurrence >90 days prior to enrolment, and the last relatively pain-free time >90 days prior to enrolment.
  3. Continuing low back pain despite >90 days of medical management
  4. Oswestry Disability Index score ≥25% and ≤60% at the time of enrolment
  5. Able to understand and sign the Informed Consent form.
  6. Ability to comply with the instructions for use and to operate the ReActiv8, and to comply with this Clinical Investigation Plan.
  7. Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
  8. Prior week average Low Back Pain NRS of ≥6.0 and ≤9.0 on a 11 point NRS scale (0-10) at the Baseline Visit

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)
  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
  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

  • Pain Medicine of South Australia
  • Hunter Clinical Research
  • Metro Spinal Clinic
  • Precision, Brain, Spine and Pain Centre
  • Georgius Practice
  • GZA Hospitals
  • AZ Nikolaas
  • Basildon & Thurrock University Hospitals
  • Southmead Hospital
  • Ipswich Hospital
  • Seacroft Hospital
  • The Walton Centre
  • St. Bartholomew's Hospital
  • James Cook University Hospital
  • Southampton University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReActiv8 Implant

Arm Description

Outcomes

Primary Outcome Measures

11 Point Numerical Rating Scale (NRS) for Low Back Pain
Number of subjects with Adverse Events

Secondary Outcome Measures

Oswestry Disability Index

Full Information

First Posted
November 5, 2013
Last Updated
October 17, 2023
Sponsor
Mainstay Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01985230
Brief Title
ReActiv8 for Chronic Low Back Pain (PMCF)
Acronym
ReActiv8-A
Official Title
Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
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 Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ReActiv8 Implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ReActiv8 Implantable Stimulation System implanted and activated.
Primary Outcome Measure Information:
Title
11 Point Numerical Rating Scale (NRS) for Low Back Pain
Time Frame
90 days
Title
Number of subjects with Adverse Events
Time Frame
90 days, 12 months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Subject Global Impression of Change
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years, ≤65 years Chronic Low Back Pain with a first occurrence >90 days prior to enrolment, and the last relatively pain-free time >90 days prior to enrolment. Continuing low back pain despite >90 days of medical management Oswestry Disability Index score ≥25% and ≤60% at the time of enrolment Able to understand and sign the Informed Consent form. Ability to comply with the instructions for use and to operate the ReActiv8, and to comply with this Clinical Investigation Plan. Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion. Prior week average Low Back Pain NRS of ≥6.0 and ≤9.0 on a 11 point NRS scale (0-10) at the Baseline Visit 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) 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 Planned surgery. Co-morbid chronic pain conditions Other clinical conditions Psycho-social exclusions Protocol Compliance Exclusions General exclusions
Facility Information:
Facility Name
Pain Medicine of South Australia
City
Adelaide
Country
Australia
Facility Name
Hunter Clinical Research
City
Broadmeadow
Country
Australia
Facility Name
Metro Spinal Clinic
City
Caulfield South
Country
Australia
Facility Name
Precision, Brain, Spine and Pain Centre
City
Kew
Country
Australia
Facility Name
Georgius Practice
City
Noosa Heads
Country
Australia
Facility Name
GZA Hospitals
City
Antwerp
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint Niklaas
Country
Belgium
Facility Name
Basildon & Thurrock University Hospitals
City
Basildon
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
Country
United Kingdom
Facility Name
Seacroft Hospital
City
Leeds
Country
United Kingdom
Facility Name
The Walton Centre
City
Liverpool
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom
Facility Name
Southampton University Hospitals
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34478115
Citation
Thomson S, Chawla R, Love-Jones S, Sharma M, Vajramani G, Williams A, Eldabe S; ReActiv8 PMCF Investigators. Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort. Pain Ther. 2021 Dec;10(2):1451-1465. doi: 10.1007/s40122-021-00307-3. Epub 2021 Sep 3.
Results Reference
derived

Learn more about this trial

ReActiv8 for Chronic Low Back Pain (PMCF)

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