N/A
Completed N=64
OPTIONS Spinal Cord Stimulation Programming Parameters
Pain, Intractable
Source: ClinicalTrials.gov NCT02503787 ↗
Enrolled (actual)
64
Serious AEs
2.1%
Results posted
Sep 2017
Primary outcomePrimary: Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire — -3.7 units on a scale — p=<0.01
Summary
The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire |
-3.7 | <0.01 sig |
| SECONDARY Patient Global Impression of Change |
10; 12; 6; 1; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
- Willing and able to provide a signed and dated informed consent
- At least 18 years old at the time of informed consent
- Willing and able to attend visits and comply with the study protocol
- Capable of using the patient programmer and recharging the neurostimulator
- Willing to not increase pain medications from baseline through the 3-Month Visit
Exclusion Criteria
- Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
- Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
- Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
- Implanted with a cardiac device (e.g., pacemaker, defibrillator)
Data sourced from ClinicalTrials.gov (NCT02503787). 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.