Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

NCT ID: NCT04073446

Last Updated: 2023-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2021-10-01

Brief Summary

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

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dorsal Column (DC) Perception

Use of DC Perception based programming

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulation

Intervention Type DEVICE

Patients eligible for SCS

Dorsal Root (DR) Perception

Use of DR Perception based programming

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulation

Intervention Type DEVICE

Patients eligible for SCS

Dorsal Root (DR) Sub-perception

Use of DR sub-perception based programming

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulation

Intervention Type DEVICE

Patients eligible for SCS

Dorsal Column (DC) Sub-perception

Use of DC sub-perception based programming

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulation

Intervention Type DEVICE

Patients eligible for SCS

Interventions

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Spinal Cord Stimulation

Patients eligible for SCS

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roshini Jain

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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AZ Nikolaas

Sint-Niklaas, , Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A4068

Identifier Type: -

Identifier Source: org_study_id

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