Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation (FOCAL)

March 27, 2023 updated by: Boston Scientific Corporation
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Sint-Niklaas, Belgium
        • AZ Nikolaas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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

Key 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dorsal Column (DC) Perception
Use of DC Perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS
Active Comparator: Dorsal Root (DR) Perception
Use of DR Perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS
Active Comparator: Dorsal Column (DC) Sub-perception
Use of DC sub-perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS
Active Comparator: Dorsal Root (DR) Sub-perception
Use of DR sub-perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: up to 6 weeks

Change in pain intensity from Baseline to end of each Period (knee/foot).

Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible.
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2019

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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