Skip to main content
OpenTrials
Completed

NCT Number: NCT04073446

Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Nikolaas

Sint-Niklaas, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Cord Stimulation

Device

Patients eligible for SCS

Primary outcomes

  1. Change in Pain Intensity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: FOCAL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2019
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.