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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02577354




Registration number
NCT02577354
Ethics application status
Date submitted
12/10/2015
Date registered
16/10/2015
Date last updated
19/12/2018

Titles & IDs
Public title
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
Scientific title
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
Secondary ID [1] 0 0
950057
Universal Trial Number (UTN)
Trial acronym
ReActiv8-B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ReActiv8 Implantable Stimulation System (Subject Appropriate Stimulation)
Treatment: Devices - ReActiv8 Implantable Stimulation System (Low Stimulation)

Experimental: Treatment -

Experimental: Control -


Treatment: Devices: ReActiv8 Implantable Stimulation System (Subject Appropriate Stimulation)
ReActiv8 implanted and configured to deliver stimulation at a Subject-appropriate level and subjects instructed to deliver stimulation in two 30-minute sessions per day.

Treatment: Devices: ReActiv8 Implantable Stimulation System (Low Stimulation)
ReActiv8 implanted and configured to deliver low stimulation, and subjects instructed to deliver stimulation in two 30-minute sessions per day.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Endpoint - Comparison of responder rates for low back pain VAS between Treatment and Control groups.
The Primary Efficacy Endpoint is a comparison of responder rates between Treatment and Control groups, where a "responder" is a Subject with =30% reduction from baseline in average low back pain VAS.
Timepoint [1] 0 0
4 months
Primary outcome [2] 0 0
Primary Safety Assessment - The primary safety assessment is of serious device and/or procedure related adverse events in all subjects in the Intent to Treat Cohort at the primary Endpoint Assessment visit.
Timepoint [2] 0 0
4 months
Secondary outcome [1] 0 0
Secondary Efficacy Endpoint - Comparison of change in Oswestry Disability Index (ODI) between Treatment and Control groups at the Primary End Point Assessment Visit.
Timepoint [1] 0 0
4 months
Secondary outcome [2] 0 0
Secondary Efficacy Endpoint - Comparison of change in EQ-5D between Treatment and Control groups at the Primary End Point Assessment Visit.
Timepoint [2] 0 0
4 months

Eligibility
Key inclusion criteria
1. Age =22 years, =75 years

2. Chronic Low Back Pain that has persisted >90 days prior to the baseline visit.

3. Continuing low back pain despite >90 days of medical management.

4. Qualifying pain score.

5. Qualifying disability score.

6. Evidence of lumbar multifidus muscle dysfunction.

7. Be willing and capable of giving Informed Consent.

8. Ability to comply with the instructions for use and to operate ReActiv8, and to comply
with this Clinical Investigation Plan.

9. Suitable for ReActiv8 surgery as determined by the implanting physician prior to
inclusion.
Minimum age
22 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

6. Pathology seen on MRI that is clearly identified and is likely the cause of the
CLBP that is amenable to surgery.

7. Back pain due to vascular causes such as aortic aneurysm and dissection.

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 that is amenable to surgery.

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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Sunshine Coast Clinical Research - Noosa Heads
Recruitment hospital [3] 0 0
Pain Medicine of South Australia - Welland
Recruitment hospital [4] 0 0
Monash Clinical Research - Clayton
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Noosa Heads
Recruitment postcode(s) [3] 0 0
- Welland
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Rhode Island
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
United States of America
State/province [12] 0 0
West Virginia
Country [13] 0 0
Belgium
State/province [13] 0 0
Sint-Niklaas
Country [14] 0 0
Belgium
State/province [14] 0 0
Wilrijk
Country [15] 0 0
Netherlands
State/province [15] 0 0
Rotterdam
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Leeds
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mainstay Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the
treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in
conjunction with medical management.
Trial website
https://clinicaltrials.gov/show/NCT02577354
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Gilligan, MD, MBA
Address 0 0
Brigham and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications