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Recruiting NCT01550575

Patient Retrospective Outcomes (PRO)

Observational Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non Boston Scientific Systems, Boston Scientific Systems.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, France, Germany +9
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

Detailed description

This study is a retrospective, multi-center, de-identified patient data review.

The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.

Interventions

  • Device Non Boston Scientific Systems
    Spinal cord stimulation, RF, IDS etc.
  • Device Boston Scientific Systems
    Spinal cord stimulation, RF, IDS etc

Primary outcome measures

  • Responder rate [Time frame: Through study completion, approximately two years]

Eligibility criteria

Inclusion criteria

  • Previously treated with or eligible for use with Boston Scientific Systems
  • 18 years of age or older at the start of Baseline

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 87 centers
  • Lakeside Spine & Pain — Lake Havasu City
  • Hope Research Institute — Phoenix
  • Kern Neuroscience Institute — Bakersfield
  • Pain Consultants of San Diego — Chula Vista
  • Pain Medicine Associates, Inc. — Fountain Valley
  • UCSD Medical Center - Jacobs Medical Center — La Jolla
  • California Orthopedics & Spine — Larkspur
  • MarinHealth Spine Institute — Larkspur
  • … and 79 more centers
Spain · 15 centers

Center list to be confirmed — check the primary protocol.

Australia · 8 centers

Center list to be confirmed — check the primary protocol.

France · 7 centers

Center list to be confirmed — check the primary protocol.

Italy · 7 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 6 centers

Center list to be confirmed — check the primary protocol.

Germany · 5 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 2 centers

Center list to be confirmed — check the primary protocol.

Switzerland · 2 centers

Center list to be confirmed — check the primary protocol.

Belgium · 1 center

Center list to be confirmed — check the primary protocol.

Portugal · 1 center

Center list to be confirmed — check the primary protocol.

Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Sweden · 1 center

Center list to be confirmed — check the primary protocol.

Turkey (Türkiye) · 1 center

Center list to be confirmed — check the primary protocol.

Publications

  • Ferro R, North J, Kranenburg A, Pyles S, Dorenkamp C, Poston J, Schneider J, Auten K, Goldberg E. Automated Neural Dosing for Fast-Acting Subperception Therapy: Sustained Spinal Cord Stimulation Outcomes from a Multicenter Study. Pain Ther. 2025 Aug;14(4):1417-1429. doi: 10.1007/s40122-025-00758-y. Epub 2025 Jul 3. PMID 40603812
  • Metzger C, Hammond B, Ferro R, North J, Pyles S, Kranenburg A, Washabaugh E, Goldberg E. Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States. Expert Rev Med Devices. 2025 Jan-Feb;22(2):155-164. doi: 10.1080/17434440.2025.2453554. Epub 2025 Jan 16. PMID 39819320

Identifiers

NCT: NCT01550575 · A7005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗