Low Back PainNCT06400602
Health Coaching for Back Pain After Emergency Department Discharge
A study testing Usual ED Care plus Health Coaching and Usual ED Care plus Education in people with Low Back Pain, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Usual ED Care plus Health Coaching and Usual ED Care plus Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tennessee Valley Healthcare System - Nashville VA Medical Center
Nashville, Tennessee, 37212
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Low Back Pain
- Being tested
- Usual ED Care plus Health Coaching, Usual ED Care plus Education
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual ED Care plus Health CoachingBehavioural
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 EducationBehavioural
Patients will participate in eight remotely-delivered sessions of education after ED discharge. Patients will receive usual care during their ED visit.
| Study group | Role | What they receive |
|---|---|---|
| Usual ED Care plus Health Coaching | Experimental | Not described Receives: Behavioral: Usual ED Care plus Health Coaching |
| Usual ED Care plus Education | Active comparator | Not described Receives: Behavioral: Usual ED Care plus Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - study enrollment
Percentage of eligible patients enrolled into study
Measured: Baseline
Feasibility - study retention
Percentage of enrolled participants who complete assessments
Measured: 3 and 6 months after ED discharge
Feasibility - session attendance
Median and range of sessions attended
Measured: 3 months after ED discharge
Feasibility - Feasibility of Intervention Measure (FIM)
4-item questionnaire assessing feasibility of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater feasibility.
Measured: 3 months after ED discharge
Acceptability - Acceptability of Intervention Measure (AIM)
4-item questionnaire assessing acceptability of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater acceptability.
Measured: 3 months after ED discharge
Acceptability - Intervention Appropriateness Measure (IAM)
4-item questionnaire assessing appropriateness of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater appropriateness.
Measured: 3 months after ED discharge
Perceptions of intervention
Perceptions of intervention as assessed through an interview
Measured: 3 months after ED discharge
Secondary outcomes (4)
Disability - Oswestry Disability Index
10-item questionnaire assessing back-related disability. Scores range from 0 to 100, with higher scores indicating higher disability.
Measured: Baseline, 3 months after ED discharge, 6 months after ED discharge
Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)
4-item PROMIS questionnaire assessing physical function. Scores are reported as t-scores, with higher scores indicating higher physical function.
Measured: Baseline, 3 months after ED discharge, 6 months after ED discharge
Pain Interference - Patient-Reported Outcomes Measurement Information System
4-item PROMIS questionnaire assessing pain interference. Scores are reported as t-scores, with higher scores indicating higher pain interference.
Measured: Baseline, 3 months after ED discharge, 6 months after ED discharge
Pain Intensity - Patient-Reported Outcomes Measurement Information System
Single item question assessing level of pain intensity. Scores range from 0 to 10, with higher scores indicating higher pain intensity.
Measured: Baseline, 3 months after ED discharge, 6 months after ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start6 May 2024
- Primary completion11 Feb 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogelio Coronado, Vanderbilt University Medical Center
- Investigators
- Rogelio Coronado, PT, PhD, Principal investigator, Vanderbilt University Medical CenterKristin Archer, PhD, DPT, Study director, Vanderbilt University Medical CenterSean Collins, MD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400602
- Sponsor's protocol ID
- 231665
- Status last verified
- Apr 2026
- First submitted
- 1 May 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model
- ClinicalTrials.gov ID
- NCT06400602
- Acronym / sponsor ID
- 231665
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual ED Care plus Health Coaching | Experimental | Behavioral: Usual ED Care plus Health Coaching |
| Usual ED Care plus Education | Active comparator | Behavioral: Usual ED Care plus Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual ED Care plus Health CoachingPatients will participate in eight remotely-delivered sessions of health coaching after ED discharge. Patients will receive usual care during their ED visit. | Behavioural | Usual ED Care plus Health Coaching |
| Usual ED Care plus EducationPatients will participate in eight remotely-delivered sessions of education after ED discharge. Patients will receive usual care during their ED visit. | Behavioural | Usual ED Care plus Education |
Primary outcome
Feasibility - study enrollment
Time frame: Baseline
Percentage of eligible patients enrolled into study
Feasibility - study retention
Time frame: 3 and 6 months after ED discharge
Percentage of enrolled participants who complete assessments
Feasibility - session attendance
Time frame: 3 months after ED discharge
Median and range of sessions attended
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.
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.
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.
Perceptions of intervention
Time frame: 3 months after ED discharge
Perceptions of intervention as assessed through an interview
4 secondary outcomes
Disability - Oswestry Disability Index
Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge
Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge
Pain Interference - Patient-Reported Outcomes Measurement Information System
Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge
Pain Intensity - Patient-Reported Outcomes Measurement Information System
Time frame: Baseline, 3 months after ED discharge, 6 months after ED discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogelio Coronado, PT, PhD principal investigator
Vanderbilt University Medical Center
Kristin Archer, PhD, DPT study director
Vanderbilt University Medical Center
Sean Collins, MD study director
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual ED Care plus Health Coaching and Usual ED Care plus Education in people with Low Back Pain, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - study enrollment (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.