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Treatment group A for Chronic Pain
Phase 2 & 3
Waitlist Available
Led By James North, MD
Research Sponsored by The Center for Clinical Research, Winston-Salem, NC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, and 6 months; at the completion of each treatment groups.
Awards & highlights
Study Summary
A randomized controlled with cross over study compares efficacy of burst stimulation, 1000 hertz stimulation, and standard stimulation in an non-superiority trial. The study duration is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks with approximately 4 days of wash off in between.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, and 6 months; at the completion of each treatment groups.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, and 6 months; at the completion of each treatment groups.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
NPRS
Secondary outcome measures
Oswestry Disability Index
Patients Global Impression of Change
Preferability Survey
Trial Design
2Treatment groups
Active Control
Group I: Treatment group AActive Control1 Intervention
Group A will consist of sequence of treatment with 3 stimulation modes. They are, in order, 1000 hertz, standard, and burst stimulation. Each stimulation modes will last 3 weeks, with 4 days of wash off between them. Each group treatments will take about 3 months, and subject will cross over into the other treatment group. Burst stimulation sends packets of electrical pulses, composed of pulse and packet frequency. 1000 hertz stimulation delivers tonic, sub perception stimulation. The standard stimulation mode, which will serve as the control, will be below 100 hertz, and its pulse strength will be above threshold, where patients will feel the tingling from the electrical pulses generated by the spinal cord stimulator.
Group II: Treatment group BActive Control1 Intervention
Group B will consist of sequence of treatment with 3 stimulation modes. They are, in order, burst stimulation, standard, and 1000 hertz. Each stimulation modes will last 3 weeks, with 4 days of wash off between them. Each group treatments will take about 3 months, and subject will cross over into the other treatment group. Burst stimulation sends packets of electrical pulses, composed of pulse and packet frequency. 1000 hertz stimulation delivers tonic, sub perception stimulation. The standard stimulation mode, which will serve as the control, will be below 100 hertz, and its pulse strength will be above threshold, where patients will feel the tingling from the electrical pulses generated by the spinal cord stimulator.
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Who is running the clinical trial?
The Center for Clinical Research, Winston-Salem, NCLead Sponsor
4 Previous Clinical Trials
115 Total Patients Enrolled
2 Trials studying Chronic Pain
71 Patients Enrolled for Chronic Pain
James North, MDPrincipal InvestigatorThe Center for Clinical Research
1 Previous Clinical Trials
34 Total Patients Enrolled
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