N/A N=64 Treatment

OPTIONS Spinal Cord Stimulation Programming Parameters

Pain, Intractable

Bottom Line

View on ClinicalTrials.gov: NCT02503787 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Sep 2017

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Spinal Cord Stimulation (SCS) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MedtronicNeuro
Primary completion: Aug 2016

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.