Spinal Cord Stimulation for pain control in patients with chronic pain. External Trial Stimulator R52.2
Conditions
Interventions
Group 1: After signing the patient consent form, the patient will undergo a standard physical exam and complete several questionnaires. After 3-14 days, the commercial electrodes are implanted and the
Sponsors
Nalu Medical, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects have been diagnosed with chronic, intractable pain of the low back and/or leg(s) (VAS = 6 for one or both leg(s) and/or back), which has been refractory to conservative therapy, after surgical intervention for a minimum of 6 months (post-lumbar laminectomy syndrome, failed back surgery syndrome, FBSS). Conservative pre- and post-operative measures may have included, but not exclusive to, physical therapy, medication management, epidural injections, facet blocks and/or denervation without material long-term response. Failure of any intervention is defined as return of symptoms to pre-intervention levels after 6 weeks. Have been approved by their doctor to undergo a commercial trial of SCS.
Exclusion criteria
Exclusion criteria: 1. Have 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 2. Have 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 outcomes 3. Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, progressive neurologic disorder (e.g., polyneuropathy, MS) or uncontrolled diabetes mellitus 4. Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region 5. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker 6. Have a condition currently requiring or likely to require the use of MRI or diathermy 7. Have pain due to a malignant disease 8. Have a life expectancy of less than 1 year 9. Have an active systemic or local infection 10. Be pregnant or nursing 11. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit drugs) 12. Be concomitantly participating in another clinical study 13. Are under active workers’ compensation (or personal injury) litigation or adjudication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: 1) SAE's during treatment in the period 3-15 days after joining the Nalu Medical neurostimulator. 2) The effectiveness measured with the VAS / NRS score between baseline and the active period 3-15 days after that connect from the Nalu Medical Neurostimulator. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are during the active period of the Nalu Medical Neurostimulator (Visit 2-4): - All reported adverse events - Baseline change from short-pain inventory (BPI questionnaire) - Comparison of pain and paraesthesia maps questionnaire - Patient satisfaction questionnaire (Likert Score questionnaire) | — |
Countries
Germany, United Kingdom
Contacts
Public ContactRaj Khullar
London City & East REC
Outcome results
None listed