ReActiv8 for Chronic Low Back Pain (PMCF)

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Device: ReActiv8 Implantable Stimulation System implanted and activated.

• Registration Number: NCT01985230
• Lead Sponsor: Mainstay Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Study Start: 2014-02
• Primary Completion: 2016-03
• Study Completion: 2024-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReActiv8 Implant	ReActiv8 Implantable Stimulation System implanted and activated.	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Events	90 days, 12 months
11 Point Numerical Rating Scale (NRS) for Low Back Pain	90 days

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	90 days

Trial Locations

Locations (15)

Pain Medicine of South Australia; 🇦🇺 Adelaide, Australia

Hunter Clinical Research; 🇦🇺 Broadmeadow, Australia

Metro Spinal Clinic; 🇦🇺 Caulfield South, Australia

Precision, Brain, Spine and Pain Centre; 🇦🇺 Kew, Australia

GZA Hospitals; 🇧🇪 Antwerp, Belgium

Georgius Practice; 🇦🇺 Noosa Heads, Australia

AZ Nikolaas; 🇧🇪 Sint Niklaas, Belgium

Basildon & Thurrock University Hospitals; 🇬🇧 Basildon, United Kingdom

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Ipswich Hospital; 🇬🇧 Ipswich, United Kingdom

The Walton Centre; 🇬🇧 Liverpool, United Kingdom

Seacroft Hospital; 🇬🇧 Leeds, United Kingdom

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom

Southampton University Hospitals; 🇬🇧 Southampton, United Kingdom