N/A N=140 Randomized Treatment

Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT02314000 ↗

Enrolled (actual)

140

Serious AEs

3.3%

Results posted

Apr 2019

Primary outcome: Primary: Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline — 32; 41 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Precision or Precision Spectra Spinal Cord Stimulator System (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline	32; 41	—

Summary

To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Eligibility Criteria

Key Inclusion Criteria

Complaint of chronic pain of the trunk and/or limbs
Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Key Exclusion Criteria

Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes

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Data sourced from ClinicalTrials.gov (NCT02314000). 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.