Chronic Pain
Conditions
Keywords
Spinal Cord Stimulation, Chronic Pain
Brief summary
The purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of Spinal Cord Stimulation (SCS) in the treatment of chronic, intractable limb pain resulting from painful Diabetic Peripheral Neuropathy (pDPN).
Interventions
Boston Scientific Spinal Cord Stimulation Systems with multiple modalities
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines. * Willing and able to comply with all protocol-required procedures and assessments/evaluations. * Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement. * Subject signed a valid, EC-approved informed consent form (ICF) provided in local language. Key
Exclusion criteria
* Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN). * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study. * Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump). * A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief in Limb Pain | Up to 12 months follow up | Percent Pain Relief (PPR) in limb pain using a questionnaire where 100% is complete relief and 0% is no relief in pain compared with Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Impression of Change | Up to 12 months follow up | Patient global impression of change (PGI-C) at 3-, 6- and 12-Month Assessment Visit where patients use a seven-point scale to assess how much their condition has improved or worsened relative to their baseline. Subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse. |
Countries
Spain
Contacts
STUDY_DIRECTORNatalie Bloom Lyons
Boston Scientific Neuromodulation Corporation
Outcome results
None listed