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NCT Number: NCT04267588

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Behavioral Medicine Research Lab

Baltimore, Maryland, 21224, United States

Location status: Recruiting

Location contact

Katie Dunnock

CONTACT

410-550-6165

Luis Buenaver, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Navio Mobile App

Other

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

Primary outcomes

  1. Patterns of self-reported clinical Pain

    Time frame: Up to 2 weeks

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

  2. Patterns of Pain Catastrophizing

    Time frame: Up to 2 weeks

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

  3. Patterns of Positive Mood

    Time frame: Up to 2 weeks

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

  4. Patterns of Negative Mood

    Time frame: Up to 2 weeks

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

Secondary outcomes

  1. Patient Adherence as assessed by completion of questionnaire on the app

    Time frame: Up to 2 weeks

    Daily and weekly patterns of electronic (i.e. mobile app) questionnaire completion will be assessed to determine compliance with the use of the app.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis F Buenaver, Ph. D

CONTACT

[email protected]

410-550-7986

Luis F Buenaver, PhD

CONTACT

[email protected]

410-550-7000

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • PainCare, LLC

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2020
Registry last updated
Jul 13, 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.

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