N/A Completed N=270 Randomized Double-blind Treatment

Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial

Chronic, Intractable Pain of the Trunk and/or Lower Limbs

Source: ClinicalTrials.gov NCT03277378 ↗

Enrolled (actual)

270

Serious AEs

1.1%

Results posted

Jan 2021

Primary outcomePrimary: Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period — 103; 93 Participants — p=0.0003

Summary

Prospective, multi-center, randomized, single blind study

Outcome Measures

Outcome	Result	p-value
PRIMARY Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period	103; 93	0.0003 sig
SECONDARY Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study	14; 6	0.2500

Eligibility Criteria

Inclusion Criteria

Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.
Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.
Patient is >18 years of age at the time of enrollment.
Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.

Exclusion Criteria

Patient currently has a spinal cord stimulation system implanted.
Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03277378). 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.