Using Technology to Track Pain and Pain-related Outcomes

Pain, Chronic Clinical Trial

Official title:

Using Technology to Track Pain and Pain-related Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04267588
• Other study ID #: IRB00196831
• Status: Recruiting
• Start date: August 10, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: Luis F Buenaver, PhD
• Phone: 410-550-7000
• Email: lbuenav1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Behavioral Medicine Research Lab	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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