Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Spinal Cord Stimulation

• Registration Number: NCT04073446
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Study Start: 2019-10-31
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Results First Submitted: 2022-09-30
• Status Verified: 2022-12
• Results First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Results First Posted: 2023-03-29
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dorsal Root (DR) Perception	Spinal Cord Stimulation	Use of DR Perception based programming
Dorsal Column (DC) Perception	Spinal Cord Stimulation	Use of DC Perception based programming
Dorsal Root (DR) Sub-perception	Spinal Cord Stimulation	Use of DR sub-perception based programming
Dorsal Column (DC) Sub-perception	Spinal Cord Stimulation	Use of DC sub-perception based programming

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity	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.

Trial Locations

Locations (1)

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium