An European multi-centre, open-label, prospective, feasibility study evaluating the Nalu Alpha External Trial Stimulator for the treatment of chronic pain via Spinal Cord Stimulation (SCS)
- Conditions
- Spinal Cord Stimulation for pain control in patients with chronic pain.External Trial StimulatorR52.2Other chronic pain
- Registration Number
- DRKS00013981
- Lead Sponsor
- alu Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints are: <br>1) SAE's during treatment in the period 3-15 days after joining the Nalu Medical neurostimulator.<br>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 Outcome Measures
Name Time Method The secondary endpoints are during the active period of the Nalu Medical Neurostimulator (Visit 2-4):<br>- All reported adverse events<br>- Baseline change from short-pain inventory (BPI questionnaire)<br>- Comparison of pain and paraesthesia maps questionnaire<br>- Patient satisfaction questionnaire (Likert Score questionnaire)