ReActiv8 for Chronic Low Back Pain (PMCF)

NCT01985230 | Completed DMC

• 1 other identifier: 950002
• Study Type: interventional
• Target: 96
• Locations: 3 countries
• Sites: 15

Brief Summary

The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 11 Point Numerical Rating Scale (NRS) for Low Back Pain

  90 days

• Number of subjects with Adverse Events

  90 days, 12 months

Secondary Outcomes (1)

• Oswestry Disability Index

  90 days

Other Outcomes (1)

• Subject Global Impression of Change

  90 days

Study Arms (1)

ReActiv8 Implant

EXPERIMENTAL

Device: ReActiv8 Implantable Stimulation System implanted and activated.

Interventions

ReActiv8 Implantable Stimulation System implanted and activated. DEVICE

ReActiv8 Implant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mainstay Medical: lead

Study Sites (15)

Pain Medicine of South Australia

Adelaide, Australia

Location

Hunter Clinical Research

Broadmeadow, Australia

Location

Metro Spinal Clinic

Caulfield South, Australia

Location

Precision, Brain, Spine and Pain Centre

Kew, Australia

Location

Georgius Practice

Noosa, Australia

Location

GZA Hospitals

Antwerp, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

Basildon & Thurrock University Hospitals

Basildon, United Kingdom

Location

Southmead Hospital

Bristol, United Kingdom

Location

Ipswich Hospital

Ipswich, United Kingdom

Location

Seacroft Hospital

Leeds, United Kingdom

Location

The Walton Centre

Liverpool, United Kingdom

Location

St. Bartholomew's Hospital

London, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Southampton University Hospitals

Southampton, United Kingdom

Location

Related Publications (3)

• Thomson S, Williams A, Vajramani G, Sharma M, Love-Jones S, Chawla R, Eldabe S. 5-year longitudinal follow-up of patients treated for chronic mechanical low back pain using restorative neurostimulation. Reg Anesth Pain Med. 2025 Aug 14:rapm-2025-106899. doi: 10.1136/rapm-2025-106899. Online ahead of print.

  PMID: 40813075 DERIVED

• Thomson S, Williams A, Vajramani G, Sharma M, Love-Jones S, Chawla R, Eldabe S. Restorative neurostimulation for chronic mechanical low back pain - Three year results from the United Kingdom post market clinical follow-up registry. Br J Pain. 2023 Oct;17(5):447-456. doi: 10.1177/20494637231181498. Epub 2023 Jun 6.

  PMID: 38107760 DERIVED

• 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.

  PMID: 34478115 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 15, 2013
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

GB (8); AU (5); BE (2)