ReActiv8 for Chronic Low Back Pain (PMCF)

Chronic Low Back Pain Clinical Trial

— ReActiv8-A  

Official title:

Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985230
• Other study ID #: 950002
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: March 2024

Study information

• Verified date: May 2024
• Source: Mainstay Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2024
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• ReActiv8 Implantable Stimulation System implanted and activated.

Locations

Country	Name	City	State
Australia	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	Georgius Practice	Noosa Heads
Belgium	GZA Hospitals	Antwerp
Belgium	AZ Nikolaas	Sint Niklaas
United Kingdom	Basildon & Thurrock University Hospitals	Basildon
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	Seacroft Hospital	Leeds
United Kingdom	The Walton Centre	Liverpool
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Southampton University Hospitals	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Mainstay Medical

Countries where clinical trial is conducted

Australia,  Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject Global Impression of Change		90 days
Primary	11 Point Numerical Rating Scale (NRS) for Low Back Pain		90 days
Primary	Number of subjects with Adverse Events		90 days, 12 months
Secondary	Oswestry Disability Index		90 days