Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06400602

Health Coaching for Back Pain After Emergency Department Discharge

The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED).

The main questions this feasibility trial aims to answer are:

* Is our health coaching intervention and randomized trial methodology feasible to conduct? * Is our health coaching intervention acceptable to participants and ED providers?

Participants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tennessee Valley Healthcare System - Nashville VA Medical Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

This study is a two-group randomized feasibility trial of usual ED care plus either remote health coaching or remote education in patients with acute exacerbation of chronic low back pain presenting to the ED. We hypothesize that our health coaching intervention and randomized trial methodology will be feasible and that our health coaching intervention will be acceptable to participants and ED providers.

Forty participants will be randomized (20 per group), with 36 (90%) retained in the trial up to 6 months follow-up. Eligible patients presenting to the ED with a chief complaint of acute exacerbation of chronic low back pain will be randomized. Patients will be enrolled during or shortly after their ED visit, asked to complete a baseline questionnaire, and then randomized. Randomized participants will receive 8 calls from either a health coach or education provider, and be asked to complete assessments at 3 and 6 months after ED discharge. Interviews will be conducted with randomized participants and 15 ED providers asking about their experience with the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chief complaint of musculoskeletal LBP
  • Meets NIH-supported chronic LBP criterion (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months)
  • Age 18 years of age or older
  • English-speaking

Exclusion criteria

  • Requires hospitalization for an acute medical condition or active comorbidity
  • In the opinion of the investigator has a severe psychiatric or behavioral diagnosis or substance use disorder that would interfere with the ability to perform the intervention and complete follow-up
  • Involved in litigation related to the LBP condition

Treatment and study plan

Usual ED Care plus Health Coaching

Behavioral

Patients will participate in eight remotely-delivered sessions of health coaching after ED discharge. Patients will receive usual care during their ED visit.

Usual ED Care plus Education

Behavioral

Patients will participate in eight remotely-delivered sessions of education after ED discharge. Patients will receive usual care during their ED visit.

Primary outcomes

  1. Feasibility - study enrollment

    Time frame: Baseline

    Percentage of eligible patients enrolled into study

  2. Feasibility - study retention

    Time frame: 3 and 6 months after ED discharge

    Percentage of enrolled participants who complete assessments

  3. Feasibility - session attendance

    Time frame: 3 months after ED discharge

    Median and range of sessions attended

  4. Feasibility - Feasibility of Intervention Measure (FIM)

    Time frame: 3 months after ED discharge

    4-item questionnaire assessing feasibility of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater feasibility.

  5. Acceptability - Acceptability of Intervention Measure (AIM)

    Time frame: 3 months after ED discharge

    4-item questionnaire assessing acceptability of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater acceptability.

  6. Acceptability - Intervention Appropriateness Measure (IAM)

    Time frame: 3 months after ED discharge

    4-item questionnaire assessing appropriateness of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater appropriateness.

  7. Perceptions of intervention

    Time frame: 3 months after ED discharge

    Perceptions of intervention as assessed through an interview

Secondary outcomes

  1. Disability - Oswestry Disability Index

    Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge

    10-item questionnaire assessing back-related disability. Scores range from 0 to 100, with higher scores indicating higher disability.

  2. Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge

    4-item PROMIS questionnaire assessing physical function. Scores are reported as t-scores, with higher scores indicating higher physical function.

  3. Pain Interference - Patient-Reported Outcomes Measurement Information System

    Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge

    4-item PROMIS questionnaire assessing pain interference. Scores are reported as t-scores, with higher scores indicating higher pain interference.

  4. Pain Intensity - Patient-Reported Outcomes Measurement Information System

    Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge

    Single item question assessing level of pain intensity. Scores range from 0 to 10, with higher scores indicating higher pain intensity.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 6, 2024
Registry last updated
Apr 28, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.