Phase 4
N=22
High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
Chronic Pain · Low Back Pain · Radiculopathy · Complex Regional Pain Syndrome (CRPS)
Bottom Line
View on ClinicalTrials.gov: NCT02265848 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Numeric Pain Rating Scale (NPRS) — 6.09; 6.27; 3.73; 3.82 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- High frequency stimulation (Other); Low frequency stimulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Center for Clinical Research, Winston-Salem, NC
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Pain Rating Scale (NPRS) |
6.09; 6.27; 3.73; 3.82; 5.64; 6.09 | — |
| SECONDARY Oswestry Disability Index Questionnaire (ODI). |
47.49; 51.25; 39.23; 33.77; 49.63; 49.05 | — |
| SECONDARY Patient's Global Impression of Change (PGIC) |
4.27; 5.91; 2.54; 2.45; 1.45; 1.27 | — |
Summary
Study designed to compare the conventional stimulation programming versus the high frequency stimulation programming of the spinal cord stimulator for subjects who already have a spinal cord stimulator.
Eligibility Criteria
Inclusion Criteria
- Subject must be 18 years and older, and younger than 70 years of age.
- Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
- Subject pain scores >5 on NPRS
Exclusion Criteria
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- Unstable medical or psychiatric illness
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Substance abuse in the last 6 months
- Pregnant or breastfeeding
- Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- Treatment with investigational drug within 30 days of screening.
- Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines
Data sourced from ClinicalTrials.gov (NCT02265848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.