Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

N/ACompletedNCT04073446

Boston Scientific Corporation3 enrolled

Overview

To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Pain

Interventions

Spinal Cord StimulationDEVICE

Patients eligible for SCS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score * Subject signed a valid, EC-approved informed consent form (ICF) * Willing and able to comply with all protocol-required procedures and assessments/evaluations * 18 years of age or older when written informed consent is obtained Key Exclusion Criteria: * Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Locations (1)

AZ Nikolaas

Sint-Niklaas, Belgium

Outcomes

Primary Outcomes

Change in Pain Intensity

Change in pain intensity from Baseline to end of each Period (knee/foot). Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible.

Time frame: up to 6 weeks

Data from ClinicalTrials.gov

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