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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01985230




Registration number
NCT01985230
Ethics application status
Date submitted
5/11/2013
Date registered
15/11/2013
Date last updated
30/05/2024

Titles & IDs
Public title
ReActiv8 for Chronic Low Back Pain (PMCF)
Scientific title
Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain
Secondary ID [1] 0 0
950002
Universal Trial Number (UTN)
Trial acronym
ReActiv8-A
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 implanted and activated.

Experimental: ReActiv8 Implant -


Treatment: Devices: ReActiv8 Implantable Stimulation System implanted and activated.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
11 Point Numerical Rating Scale (NRS) for Low Back Pain
Timepoint [1] 0 0
90 days
Primary outcome [2] 0 0
Number of subjects with Adverse Events
Timepoint [2] 0 0
90 days, 12 months
Secondary outcome [1] 0 0
Oswestry Disability Index
Timepoint [1] 0 0
90 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
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)

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
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2024
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pain Medicine of South Australia - Adelaide
Recruitment hospital [2] 0 0
Hunter Clinical Research - Broadmeadow
Recruitment hospital [3] 0 0
Metro Spinal Clinic - Caulfield South
Recruitment hospital [4] 0 0
Precision, Brain, Spine and Pain Centre - Kew
Recruitment hospital [5] 0 0
Georgius Practice - Noosa Heads
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Broadmeadow
Recruitment postcode(s) [3] 0 0
- Caulfield South
Recruitment postcode(s) [4] 0 0
- Kew
Recruitment postcode(s) [5] 0 0
- Noosa Heads
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Sint Niklaas
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Basildon
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Bristol
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Ipswich
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Leeds
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Liverpool
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Middlesbrough
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Southampton

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 Clinical Study is to investigate the effect of electrical stimulation for
chronic low back pain.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01985230
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01985230