A clinical study to evaluate pain perception with spinal cord stimulatio

Not Applicable

Completed

• Conditions: Failed back surgery syndrome; Surgery

• Registration Number: ISRCTN13607429
• Lead Sponsor: evro Corp (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-27
• Study Completion: 2019-03-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosed with failed back surgery syndrome with predominant back pain
2. Average back pain intensity of = 5 out of 10 on the Numeric Rating Scale (NRS) at enrollment
3. An appropriate candidate for Spinal Cord Stimulation as per the Belgian regulations
4. An adult (= 18 years of age) at time of enrollment
5. Evaluated at the investigational site at least once prior to screen for the pain condition related to the study
6. Willing and capable of giving written informed consent prior to any investigational related procedure
7. Willing and able to comply with study-related requirements, assessments and visits
8. Capable of subjective evaluation, able to read and understand written questionnaires, and able to read, understand and sign the written inform consent (Dutch and French)
9. Adequate cognitive ability to use a patient external trial stimulator and recharger as determined by the Investigator
10. An appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician and if applicable per the local regulations
11. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the baseline visit
12. A stable physical activity level, as determined by the Investigator and activity diary, for at least 2 weeks prior to the baseline visit

Exclusion Criteria

1. Using an daily opioid dose of >60mg oral morphine equivalents (meq) or daily >25 µg/hr transdermal fentanyl
2. 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
3. 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 a psychologist
4. 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 spinal stenosis
5. A visceral pain in the area being treated
6. A current diagnosis of a coagulation disorder, Complex Regional Pain Syndrome (CRPS), bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
7. A diagnosis of scoliosis that precludes lead placement
8. Recent evidence (imaging or letter neurosurgeon) of spinal instability requiring fusion (imaging such as flexion/extension films of lumbar spine is required for this determination and must have been done within the past 6 months)
9. Pain that is significantly exacerbated by activity or significantly alleviated by rest
10. Benefiting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain
11. An existing drug pump and/or SCS system or another active implantable device (switched on or off) such as a pacemaker or other SCS devices
12. Prior experience with SCS
13. A condition currently requiring or likely to require the use of MRI in the trunk
14. Metastatic malignant disease or active local malignant disease
15. A life expectancy of less than 1 year
16. An active systemic or local infection
17. 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)
18. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
19. Limited physical activity not due to back pain (due to e.g. knee arthrosis, arthroplasty)
20. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study and/or data collection
21. Involved in an injury claim under current litigation
22. A pending or approved worker’s compensation claim

Study & Design

• Study Type: Interventional
• Study Design: Not specified