SenzaTM Spinal Cord Stimulation System for the treatment of chronic back pai

Not Applicable

Completed

• Conditions: Signs and Symptoms; Low back pain; Chronic low back pain in subjects who have not had spinal surgery

• Registration Number: ISRCTN96424062
• Lead Sponsor: evro Corp (USA)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28025843 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29077889 (added 02/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-26
• Study Completion: 2014-03-31
• Last Update Posted: 29 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Age greater than 18 years, less than 65 years old
2. Low back pain for more than 6 months having failed conservative treatment (e.g., physical therapy, multiple facet joint injections)
3. Low back pain intensity =5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
4. Low back pain predominates over any radicular pain (VAS back pain 2 points or more greater than VAS leg pain)
5. Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography
6. On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator
7. Legally able to provide informed consent
8. Able to comply with study-related requirements, procedures and visits

Exclusion Criteria

1. Had previous spinal fusion surgery
2. A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical central or foraminal spinal stenosis
3. Mechanical spine instability detected by a spinal surgeon (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by >5 degrees segmental angular movement) e.g. any forms of spondylolisthesis
4. A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
5. Diabetic who is poorly controlled through diet and/or medication (determined by the Investigator)
6. Bleeding diathesis such as coagulopathy or thrombocytopenia
7. Immunocompromised and at an increased risk for infection
8. Systemic infection or local infection that would contraindicate SCS placement
9. Metastatic malignant disease or active local malignant disease
10. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
11. Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication.
12. Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
13. Life expectancy of less than 1 year
14. Concomitant participation in clinical trial (device or drug)
15. An existing drug pump, SCS system, and/or another active implantable device
16. An interventional procedure and/or surgery within the past 30 days for treatment of pain condition
17. Inability to manage the technical demands of the SCS equipment

Study & Design

• Study Type: Observational
• Study Design: Not specified