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NCT03681262 · ClinicalTrials.gov registry record · NA
Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
A NA study of Chronic Pain, sponsored by Stanford University.
- Active
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT03681262 is a NA study of Chronic Pain that is active but no longer recruiting, run by Stanford University. The registered enrollment target is 7 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03681262, a NA study of Chronic Pain, is active but no longer recruiting, sponsored by Stanford University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. This study aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in the department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). CHOIR uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of high frequency and burst spinal cord stimulation in improving pain and function in patients with chronic back and/or leg pain. Spinal cord stimulation is an effective treatment for chronic pain resulting in \>50% pain relief in about half of the patients. Novel waveforms for spinal cord stimulation - high frequency and burst - increased the efficacy of this treatment even further. However, there is lack of data guiding decision making of the clinicians in choosing the best waveform in treating the patients with chronic pain. The proposed study will provide the clinicians with this evidence. Currently, data about safety and efficacy of these two novel waveforms is available for up to 24 months. The proposed research will provide data about effectiveness of these two modalities for at least 36 months. Moreover, this study will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in Stanford Pain Management subspecialty clinic. CHOIR can then be applied for numerous future trials to advance knowl
Conditions Studied
Interventions
- DEVICE High frequency spinal cord stimulation
- DEVICE Burst spinal cord stimulation
Study Locations (1)
California
- Stanford Pain Management Center - Redwood City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03681262
The ClinicalTrials.gov registry entry for NCT03681262 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (99% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which High frequency spinal cord stimulation is the first listed.
NCT03681262 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03681262 about?
NCT03681262 is a clinical study titled "Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation". Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are...
What is the current status of trial NCT03681262?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 7 participants. The study started on 2019-08-01. Estimated completion is 2026-12-31.
What conditions does trial NCT03681262 study?
This clinical trial studies the following conditions: Chronic Pain.
What interventions are being tested in trial NCT03681262?
The interventions under investigation include: High frequency spinal cord stimulation (DEVICE), Burst spinal cord stimulation (DEVICE).
Who is sponsoring clinical trial NCT03681262?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03681262 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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