Chronic Neuropathic Pain, Chronic Pain Management, Failed Back Surgery Syndrome, Pain Modulation, Spinal Cord Stimulation (SCS)
Conditions
Keywords
chronic pain, spinal cord stimulation, neuropathic pain, Remote Pain Management, BurstDR Technology, Chronic Pain in Rural Populations
Brief summary
This study evaluates the effectiveness of Abbott's Proclaim™ and Eterna™ Spinal Cord Stimulator (SCS) systems, along with the Neurosphere™ virtual clinic platform, in managing chronic pain. The goal is to assess how remote monitoring and virtual care can improve pain relief and reduce healthcare costs compared to traditional in-person care. Adults with chronic pain will either receive treatment through in-person visits or remotely using Neurosphere™. The study will measure pain relief, quality of life, and healthcare expenses over six months, aiming to improve access to pain management, especially for patients in rural areas.
Interventions
DEVICESpinal Cord Stimulation - Neurosphere
Test Group Intervention: Test group participants will receive remote monitoring and therapy adjustments through the Neurosphere™ virtual clinic platform. Participants in test group will have trial and end of trial phases in clinic, but further SCS therapy will be performed through Neurosphere. Clinicians will adjust the SCS device settings, including pulse width and burst frequency, remotely. This intervention allows patients to avoid in-person visits while receiving continuous, personalized care, with follow-up assessments at 1, 3, and 6 months over a 6-month period.
DEVICESpinal Cord Stimulation - In Clinic
Control Group Intervention: In-Person SCS therapy. Device settings, such as pulse width and frequency, will be adjusted during regular clinic visits. Follow-up assessments for pain relief, quality of life, and therapy effectiveness will occur at 1, 3, and 6-month intervals over a 6-month period.
Sponsors
Mahesh Pattabiraman
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 19 years and older experiencing chronic neuropathic pain that is refractory to medical treatment and eligible for SCS based on FDA-approved indications. * Individuals who can legally provide informed consent.
Exclusion criteria
* Patients unable or unwilling to adhere to the requirements of remote monitoring, follow-up schedules, or other aspects of the study protocol. * Patients with uncontrolled psychiatric conditions, including severe depression or anxiety, which could interfere with their ability to participate fully in the study or accurately report outcomes. * Women who are currently pregnant or breastfeeding, as the safety and efficacy of SCS in these populations are not established. * Patients who have previously experienced significant adverse events or complications from SCS implantation or stimulation that would make further use unsafe or ineffective. * Patients with other active implantable devices (e.g., pacemakers or defibrillators) that could interfere with the functionality of the SCS system. * Patients with a documented history of substance abuse within * Patients with significant comorbid conditions (severe cardiovascular disease, unmanaged diabetes, uncontrolled infection, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief - NRS | Baseline, 1 month, 3 months, and 6 months post-intervention | Pain relief in numerical pain rating scale (NRS). Numerical points. |
| Quality of Life and Functional Disability Improvements - ODI | Baseline, 1 month, 3 months, and 6 months post-intervention | Change in quality of life and functional disability in participants quantified through numerical response to Oswestry Disability Index (ODI) compared to baseline |
| Healthcare Cost Reduction | From baseline to 6 months post-intervention | This outcome measures the reduction in healthcare costs associated with the use of the Neurosphere™ remote monitoring platform compared to traditional in-person care. Costs will be assessed through an analysis of healthcare resource utilization using time-driven activity-based costing TDABC methodology. |
Countries
United States
Outcome results
None listed