Using Technology to Track Pain and Pain-related Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Other: Navio Mobile App

Detailed Description

Chronic pain affects over 100 million Americans, costs the US over $630 billion annually, and reduces quality of life. It is among the most clinically challenging and financially burdensome conditions facing clinicians and healthcare organizations. Sleep disturbance is common in chronic pain conditions with some studies reporting a prevalence as high as 70%-88%. Psychiatric disorders, including substance abuse and mood disorders are prevalent in chronic pain and are associated with impairment and decreased quality of life. Sleep is increasingly recognized as a critical regulator of mental health. Taken together, epidemiological, cross-sectional, and prospective studies support the hypothesis that insomnia, chronic pain, and depression are mutually interacting, each increasing the risk for the emergence and/or exacerbation of the other. The gold standard of chronic pain management is multidisciplinary pain treatment (MPT), but patients rarely receive MPT secondary to limited access and a severe shortage of pain management specialists. Thus, there is an urgent need for empirically supported, cost-effective multidisciplinary pain self-management options that are accessible to patients and trusted by primary and tertiary care providers. To address this problem, the investigators' group in collaboration with the Johns Hopkins Technology Innovation Center (TIC) has developed a mobile chronic pain, medication and symptom tracking digital technology platform designed to eventually support multidisciplinary pain treatment by enhancing patient-provider communication and delivering comprehensive, personalized, interactive evidence-based pain management strategies. The investigators' App (version 1.3) is currently able to collect self-report data (i.e., pain; sleep; mood; catastrophizing; stress; pain flares) and continuous, passively collected wearable biosensor data (i.e., heart rate; breathing; sleep; heart rate variability/stress). The investigators propose a prospective, observational proof of concept study to demonstrate feasibility and adherence while establishing the psychometric properties of a mobile pain App and to compare these data with passively collected physiological data and laboratory indices of pain in patients with chronic low back pain (CLBP).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Luis F Buenaver, PhD; Phone Number: 410-550-7000; Email: lbuenav1@jhmi.edu
• Study Contact Backup: Name: Luis F Buenaver, Ph. D; Phone Number: 410-550-7986; Email: lbuenav1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Behavioral Medicine Research Lab
      • Contact: Katie Dunnock; Phone Number: 410-550-6165
      • Principal Investigator: Luis Buenaver, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic low back pain (CLBP).

Description

Inclusion Criteria:

• ≥ 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Adherence as assessed by completion of questionnaire on the app	Daily and weekly patterns of electronic (i.e. mobile app) questionnaire completion will be assessed to determine compliance with the use of the app.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: PainCare, LLC
• Investigators: Principal Investigator: Luis F Buenaver, Ph. D, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: IRB00196831

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No