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Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

NCT ID: NCT07190807

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2029-05-31

Brief Summary

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Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).

In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

Detailed Description

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Conditions

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Chronic Pain Intractable Pain Low Back Pain Chronic Low-back Pain Chronic Leg Pain Leg Pain

Keywords

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Spinal Cord Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Time Varied Pulse (TVP)-SCS settings

Group Type EXPERIMENTAL

Boston Scientific WaveWriter Alpha™ SCS Systems

Intervention Type DEVICE

Time Varied Pulse (TVP)-SCS settings

Interventions

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Boston Scientific WaveWriter Alpha™ SCS Systems

Time Varied Pulse (TVP)-SCS settings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.
* Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months.
* 18 years of age or older when written informed consent is obtained
* Able to independently read and complete all questionnaires and assessments provided in English.
* Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.

Exclusion Criteria

* Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
* Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
* A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
* 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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Natalie M Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Denver Back Pain Specialists

Greenwood, Colorado, United States

Site Status RECRUITING

Fox Chase Pain Management

Trevose, Pennsylvania, United States

Site Status RECRUITING

Institute of Precision Pain Medicine

Corpus Christi, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Thanh Hoang

Role: CONTACT

Phone: 855-213-9890

Email: [email protected]

Diane Keesey

Role: CONTACT

Phone: 855-213-9890

Email: [email protected]

Facility Contacts

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Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Other Identifiers

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A4116

Identifier Type: -

Identifier Source: org_study_id