Using Technology to Track Pain and Pain-related Outcomes

NCT04267588 | Recruiting DMC

• 1 other identifier: IRB00196831
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Persistent pain is a public health epidemic. The current protocol seeks to develop technology to aid patients' tracking of patients' pain, medications and pain-related variables. The investigators seek to talk with patients in co-investigator's clinic to solicit feedback, as well as pilot test the technology with pain patients.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (4)

• Patterns of self-reported clinical Pain

  Patients will complete twice-daily, electronic (i.e. via mobile app) numerical pain rating scales through Navio App.

  Up to 2 weeks

• Patterns of Pain Catastrophizing

  Patients will complete twice-daily, electronic (i.e. via mobile app) pain catastrophizing questions through Navio App.

  Up to 2 weeks

• Patterns of Positive Mood

  Patients will complete twice-daily, electronic (i.e. via mobile app) positive mood questions through Navio App.

  Up to 2 weeks

• Patterns of Negative Mood

  Patients will complete twice-daily, electronic (i.e. via mobile app) negative mood questions through Navio App.

  Up to 2 weeks

Secondary Outcomes (1)

• Patient Adherence as assessed by completion of questionnaire on the app

  Up to 2 weeks

Study Arms (1)

Navio App

The investigators propose to collect self-report and passively collected biological data and evaluate participants' relation to clinical and laboratory pain as well as patients' willingness to use and level of comfort with the mobile pain management digital platform and wearable biosensors. Eligible participants will be consented, given two biosensors (i.e., Apple Watch Series 1 with KardiaBand; Spire), a sleep monitoring device (actigraph watch), and a mobile app enabled smartphone, then trained on how to use the app (and device if appropriate) and biosensors. Participants will keep medications constant and not have any new pain treatment procedures over the course of the study period and 2 weeks prior to starting the study.

Other: Navio Mobile App

Interventions

Navio Mobile App OTHER

Participants will use the Navio Mobile App to track participants' pain and pain treatment

Navio App

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic low back pain (CLBP).

You may qualify if:

• ≥ 21 years of age
• Pain duration \> 3 months
• Average pain level of \>3 out of 10 (0=no pain; 10=worst pain imaginable)
• English fluency
• Are not scheduled to undergo any medical procedures during the course of the study
• Have a physician-confirmed medical diagnosis associated with chronic pain
• Are willing to comply with the study protocol and give written informed consent. Patients taking non-narcotic analgesics must be on a stable dose one month prior to participation.

You may not qualify if:

• Delirium, dementia, or cognitive impairment (i.e., Mini Mental State Exam score \<24)
• Unstable major psychiatric disorder or history of schizophrenia
• Beck Depression Inventory score \>30 or report of suicidal ideation
• Active substance abuse;
• Refusal to provide access to relevant medical record information.

Sponsors & Collaborators

• Johns Hopkins University: lead
• PainCare, LLC: collaborator

Study Sites (1)

Behavioral Medicine Research Lab

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Luis F Buenaver, Ph. D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis F Buenaver, PhD

CONTACT

410-550-7000; lbuenav1@jhmi.edu

Luis F Buenaver, Ph. D

CONTACT

410-550-7986; lbuenav1@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: August 10, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

US (1)