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This study evaluates the effectiveness of Abbott's Proclaimâ„¢ and Eternaâ„¢ Spinal Cord Stimulator (SCS) systems, along with the Neurosphereâ„¢ 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 Neurosphereâ„¢. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Patients receiving SCS therapy through Neutrosphere virtual clinic platform (remote pain management group). |
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| Control Group | Participants in this group will receive traditional in-person care for their SCS therapy. Group regular clinic visits for therapy adjustments, monitoring, and pain management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation - In Clinic | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief - NRS | Pain relief in numerical pain rating scale (NRS). Numerical points. | Baseline, 1 month, 3 months, and 6 months post-intervention |
| Quality of Life and Functional Disability Improvements - ODI | Change in quality of life and functional disability in participants quantified through numerical response to Oswestry Disability Index (ODI) compared to baseline | Baseline, 1 month, 3 months, and 6 months post-intervention |
| Healthcare Cost Reduction | This outcome measures the reduction in healthcare costs associated with the use of the Neurosphereâ„¢ 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. | From baseline to 6 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include adult participants aged 19 years and older who are experiencing chronic neuropathic pain that is refractory to medical treatment and are eligible for SCS therapy based on FDA-approved indications. Participants will be recruited from a rural population, with effort made for including individuals from diverse socioeconomic backgrounds. Study will enroll patients who can legally provide consent and are willing to adhere to the study protocol, including remote monitoring or in-person follow-up visits.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grand Island Pain Relief Center | Grand Island | Nebraska | 68803 | United States |
IPD related to the primary and secondary outcomes of the study, including anonymized data on pain relief, quality of life, healthcare utilization, and cost-effectiveness, will be shared. The shared data will include patient-reported outcomes (e.g., ODI and NRS for pain), as well as relevant clinical and financial data collected throughout the study. A detailed data dictionary, explaining all variables, will be provided to ensure proper interpretation. IPD will be made available upon reasonable request after publication of the study results
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| Spinal Cord Stimulation - Neurosphere | Device | Test Group Intervention: Test group participants will receive remote monitoring and therapy adjustments through the Neurosphereâ„¢ 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. |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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