NCT05515341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

3.4 years

First QC Date

August 23, 2022

Last Update Submit

July 21, 2026

Conditions

Chronic Pain

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Targeted Pain Responder Rate

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

    up to 40 months post study enrollment

Study Arms (1)

Medical Device Therapy/Procedure for Chronic Pain

Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain

Interventions

Commercially Approved Interventional Medical Device/Therapy for Chronic PainDEVICE

Commercially Approved Interventional Medical Device/Therapy

Medical Device Therapy/Procedure for Chronic Pain

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Chronic pain

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Scientific Neuromodulation

Valencia, California, 91355, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natalie B Lyons

    Boston Scientific Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

January 10, 2023

Primary Completion

May 20, 2026

Study Completion

May 20, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations

US(1)