Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
FOCAL
1 other identifier
interventional
3
1 country
1
Brief Summary
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Oct 2019
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 29, 2019
CompletedStudy Start
First participant enrolled
October 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedResults Posted
Study results publicly available
March 29, 2023
CompletedMarch 29, 2023
December 1, 2022
1.9 years
July 23, 2019
September 30, 2022
March 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 6 weeks
Study Arms (4)
Dorsal Column (DC) Perception
ACTIVE COMPARATORUse of DC Perception based programming
Dorsal Root (DR) Perception
ACTIVE COMPARATORUse of DR Perception based programming
Dorsal Root (DR) Sub-perception
ACTIVE COMPARATORUse of DR sub-perception based programming
Dorsal Column (DC) Sub-perception
ACTIVE COMPARATORUse of DC sub-perception based programming
Interventions
Patients eligible for SCS
Eligibility Criteria
You may qualify if:
- 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
- years of age or older when written informed consent is obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AZ Nikolaas
Sint-Niklaas, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roshini Jain, Sr. Director Clinical Sciences
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Roshini Jain
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
August 29, 2019
Study Start
October 31, 2019
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
March 29, 2023
Results First Posted
March 29, 2023
Record last verified: 2022-12