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

Boston Scientific

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Spinal Cord Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04073446

A4068

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 4 patient groups

Dorsal Column (DC) Perception

Active Comparator group

Description:

Use of DC Perception based programming

Treatment:

Device: Spinal Cord Stimulation

Dorsal Root (DR) Perception

Active Comparator group

Description:

Use of DR Perception based programming

Treatment:

Device: Spinal Cord Stimulation

Dorsal Root (DR) Sub-perception

Active Comparator group

Description:

Use of DR sub-perception based programming

Treatment:

Device: Spinal Cord Stimulation

Dorsal Column (DC) Sub-perception

Active Comparator group

Description:

Use of DC sub-perception based programming

Treatment:

Device: Spinal Cord Stimulation