Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

Chronic Pain Clinical Trial

— FOCAL  

Official title:

Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073446
• Other study ID #: A4068
• Status: Completed
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Spinal Cord Stimulation
Patients eligible for SCS

Locations

Country	Name	City	State
Belgium	AZ Nikolaas	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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