A feasibility study evaluating the Nalu Stimulator for the treatment of chronic pain via Spinal Cord Stimulatio
- Conditions
- Chronic pain of the low back and/or legsAnaesthesiology - Pain management
- Registration Number
- ACTRN12616001304426
- Lead Sponsor
- alu Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
1. Have a minimum or 1 surgical intervention of the lumbar spine
2..Have been diagnosed with chronic, intractable pain of the low back and/or legs.
3. Have been approved by their doctor to undergo a commercial trial of SCS.
4. Be an appropriate candidate for the surgical procedures required in this study.
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
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.
2.Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
3.Have an active systemic or local infection
4.Be pregnant or nursing
5.Be concomitantly participating in another clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain relief will be assessed by the visual analogue scale and numeric rating scale.[All assessments are made prior to and at the end of each trial period.]
- Secondary Outcome Measures
Name Time Method Pain relief will be evaluated on the basis of validated questionnaires (Brief Pain Inventory, and the Likert Scales). [All assessments are made prior to and at the end of each trial period.]