Phase 4
Completed N=21
Effect of Pulse Width With Spinal Cord Stimulation
Postoperative Pain · Back Pain
Source: ClinicalTrials.gov NCT00399516 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) — -56.1 Percent Change in Pain Rating
Summary
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) |
-56.1 | — |
Eligibility Criteria
Inclusion Criteria
- Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
- Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
- Be 18 years of age or older.
- Be willing and able to comply with all study related procedures and visits.
- Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion Criteria
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have any other chronic pain condition likely to confound evaluation of study endpoints.
Data sourced from ClinicalTrials.gov (NCT00399516). 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. Informational only — not medical advice.