Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department

Not Applicable

Terminated

• Conditions: Back Pain; Pain; Low Back Pain; Chronic Low-back Pain
• Interventions: Behavioral: Telehealth Mindfulness Program

• Registration Number: NCT04783532
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

While guideline-directed nonpharmacological strategies for chronic low back pain are well established, optimal chronic pain management for emergency department patients has yet to be defined. Mindfulness interventions can be used for management of chronic conditions, yet are understudied as a primary approach for patients with chronic pain discharged from the emergency department. Currently, there is limited evidence examining whether an individual telehealth mindfulness intervention is a feasible and acceptable for these patients. This study will develop, pilot, and evaluate the feasibility and effects of an 8-session (12-week) telehealth mindfulness intervention for patients with an acute exacerbation of chronic low back pain

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-02
• Study Start: 2021-03-05
• Study First Posted: 2021-03-05
• Primary Completion: 2021-08-05
• Study Completion: 2021-08-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age 18 years or older;
2. Presenting to the emergency department to address a chief complaint of an acute exacerbation of chronic low back pain;
3. Meets NIH-supported definition of chronic low back pain (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months); and
4. English-speaking due to feasibility of utilizing a telehealth mindfulness program developed in English

Exclusion Criteria

1. Patients requiring hospitalization for a medical severe condition or comorbidity;
2. Patients with a severe psychiatric or behavioral diagnosis or presenting symptoms, including psychosis, delirium, active suicidal ideation, or who screen positive on the Columbia Suicide Screening;
3. Patients with a history of multiple substance use or abuse;
4. Patients involved in litigation related to the chronic pain condition; and
5. Patients who are unable to comply with the telehealth intervention (i.e., unable to provide stable home address or access telehealth link on a mobile device or computer).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telehealth Mindfulness Program	Telehealth Mindfulness Program	Telehealth mindfulness sessions

Primary Outcome Measures

Name	Time	Method
Feasibility - Retention	3 months after discharge from the emergency department.	Proportion of enrolled participants who complete study.
Feasibility - Recruitment	3 months after discharge from emergency department	Proportion of eligible patients enrolled in study.
Feasibility - Session attendance	3 months after discharge from the emergency department.	Average number of sessions attended.

Secondary Outcome Measures

Name	Time	Method
Self-reported return visits to the emergency department	3 months after discharge from the emergency department.	Single item assessing return visits to emergency department.
Patient Reported Outcomes Measurement Information System - Pain Interference Short Form	Baseline and 3 months after discharge from the emergency department.	4-item pain interference short form from the 29-item Patient Reported Outcomes Measurement Information System scale. Total raw scores range from 4 to 20. A lower score indicates lower pain interference, a better outcome.
Patient Reported Outcomes Measurement Information System - Physical Function Short Form	Baseline and 3 months after discharge from the emergency department.	4-item physical function short form from the 29-item Patient Reported Outcomes Measurement Information System scale. Total raw scores range from 4 to 20. A higher score indicates higher physical function, a better outcome.
Patient Reported Outcomes Measurement Information System - Pain Intensity	Baseline and 3 months after discharge from the emergency department.	Single item from the 29-item Patient Reported Outcomes Measurement Information System scale assessing average pain intensity over the past 7 days rated on a 0 to 10 scale, with lower values indicates less pain, a better outcome.
Patient satisfaction with treatment	Baseline and 3 months after discharge from the emergency department.	Single item assessing satisfaction of overall results from telehealth mindfulness program.
Self-reported opioid medication use	Baseline and 3 months after discharge from the emergency department.	Average number of pills per day (name and dose specified) and covered to morphine equivalent dose.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States