NCT02988713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

December 13, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 4, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

November 29, 2016

Results QC Date

December 1, 2021

Last Update Submit

April 14, 2022

Conditions

Chronic Pain

Keywords

stimulationchronic painback painleg pain

Outcome Measures

Primary Outcomes (1)

  • Patient Comfort

    Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"

    An estimated average of 7 days post temporary trial procedure

Study Arms (1)

Spinal cord stimulation

EXPERIMENTAL

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

Device: Programming

Interventions

ProgrammingDEVICE

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

Spinal cord stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pacific Pain Management, Inc.

Ventura, California, 93003, United States

Location

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

Location

Related Publications (1)

  • 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.

    PMID: 38361978DERIVED

MeSH Terms

Conditions

Chronic PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director, Clinical Sciences and Scientific Communication
Organization
Boston Scientific
BSNClinicalTrials@bsci.com
855-213-9890

Study Officials

  • Roshini Jain, M.S.

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 9, 2016

Study Start

December 13, 2016

Primary Completion

December 2, 2020

Study Completion

December 2, 2020

Last Updated

April 18, 2022

Results First Posted

April 4, 2022

Record last verified: 2022-04

Locations

US(2)