A DirEct to PatieNt Study in Chronic Pain

To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in routine clinical practice.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Scientific Neuromodulation

Valencia, California, 91355, United States

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

Patient is planning to receive or has received a commercially approved interventional medical device therapy/procedure to treat chronic pain, ascertained from self-reporting
Age ≥ 22 years at time of eligibility screening, ascertained by self-reported age at time of eligibility screening
Proficient in written and spoken English, defined by self-reporting of comfort reading, writing and speaking English

Key Exclusion Criteria:

Requires a legal representative to sign the ICF ascertained from self-reporting

Treatment and study plan

Commercially Approved Interventional Medical Device/Therapy for Chronic Pain

Device

Commercially Approved Interventional Medical Device/Therapy

Primary outcomes

Targeted Pain Responder Rate

Time frame: up to 40 months post study enrollment

Percentage of subjects with a 50 percent or greater reduction in targeted pain intensity, based on self-reported percent pain relief

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: ENLITEN

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Aug 25, 2022
Registry last updated: Jul 23, 2026

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.

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

Completed