Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation (FOCAL)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Spinal Cord Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Spinal Cord Stimulation, Chronic Pain
Eligibility Criteria
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
Sites / Locations
- AZ Nikolaas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dorsal Column (DC) Perception
Dorsal Root (DR) Perception
Dorsal Root (DR) Sub-perception
Dorsal Column (DC) Sub-perception
Arm Description
Use of DC Perception based programming
Use of DR Perception based programming
Use of DR sub-perception based programming
Use of DC sub-perception based programming
Outcomes
Primary Outcome Measures
Change in Pain Intensity
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04073446
First Posted
July 23, 2019
Last Updated
March 27, 2023
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04073446
Brief Title
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Acronym
FOCAL
Official Title
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Spinal Cord Stimulation, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dorsal Column (DC) Perception
Arm Type
Active Comparator
Arm Description
Use of DC Perception based programming
Arm Title
Dorsal Root (DR) Perception
Arm Type
Active Comparator
Arm Description
Use of DR Perception based programming
Arm Title
Dorsal Root (DR) Sub-perception
Arm Type
Active Comparator
Arm Description
Use of DR sub-perception based programming
Arm Title
Dorsal Column (DC) Sub-perception
Arm Type
Active Comparator
Arm Description
Use of DC sub-perception based programming
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation
Intervention Description
Patients eligible for SCS
Primary Outcome Measure Information:
Title
Change in Pain Intensity
Description
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.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
AZ Nikolaas
City
Sint-Niklaas
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
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