Clinical trial NCT01985230: ReActiv8 for Chronic Low Back Pain (PMCF)
Official title: Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Mainstay Medical
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 11 Point Numerical Rating Scale (NRS) for Low Back Pain
timeFrame: 90 days
measure: Number of subjects with Adverse Events
timeFrame: 90 days, 12 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 90 days
Other outcomes:
measure: Subject Global Impression of Change
timeFrame: 90 days
Locations:
city: Adelaide
country: Australia
facility: Pain Medicine of South Australia
city: Broadmeadow
country: Australia
facility: Hunter Clinical Research
city: Caulfield South
country: Australia
facility: Metro Spinal Clinic
city: Kew
country: Australia
facility: Precision, Brain, Spine and Pain Centre
city: Noosa Heads
country: Australia
facility: Georgius Practice
city: Antwerp
country: Belgium
facility: GZA Hospitals
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas
city: Basildon
country: United Kingdom
facility: Basildon & Thurrock University Hospitals
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
city: Liverpool
country: United Kingdom
facility: The Walton Centre
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals
Study officials:
References:
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.