Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

NCT ID: NCT02988713

Last Updated: 2022-04-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-13

Study Completion Date

2020-12-02

Brief Summary

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This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Spinal cord stimulation

Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Group Type EXPERIMENTAL

Programming

Intervention Type DEVICE

Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Interventions

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Programming

Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU).
* Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
* Subject is 18 years of age or older when written informed consent is obtained.

Exclusion Criteria

* Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).
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, M.S.

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Pacific Pain Management, Inc.

Ventura, California, United States

Site Status

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, United States

Site Status

Countries

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United States

References

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Zhu C, Esteller R, Block J, Lechleiter K, Frey R, Moffitt MA. Exploratory evaluation of spinal cord stimulation with dynamic pulse patterns: a promising approach to improve stimulation sensation, coverage of pain areas, and expected pain relief. Front Pain Res (Lausanne). 2024 Jan 31;4:1339892. doi: 10.3389/fpain.2023.1339892. eCollection 2023.

Reference Type DERIVED
PMID: 38361978 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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91153461

Identifier Type: -

Identifier Source: org_study_id

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