Low Back PainNCT04783532
Feasibility of Telehealth Mindfulness for Back Pain in the Emergency Department
A study testing Telehealth Mindfulness Program in people with Low Back Pain and Back Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Back Pain, Pain
- What is being tested?
- Telehealth Mindfulness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 5 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 years or older;
- Presenting to the emergency department to address a chief complaint of an acute exacerbation of chronic low back pain;
- 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
- English-speaking due to feasibility of utilizing a telehealth mindfulness program developed in English
Who cannot join
- Patients requiring hospitalization for a medical severe condition or comorbidity;
- 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;
- Patients with a history of multiple substance use or abuse;
- Patients involved in litigation related to the chronic pain condition; and
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Feasibility and Acceptability of a Telehealth Mindfulness Intervention to Improve Outcomes of Patients With an Acute Exacerbation of Chronic Back Pain Presenting to the Emergency Department
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
- Conditions
- Low Back Pain, Back Pain, Pain, Chronic Low-back Pain
- Being tested
- Telehealth Mindfulness Program
- Keywords
- Mindfulness, Telehealth, Mindfulness-based intervention
- Medical subject headings
- Low Back Pain, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Mindfulness ProgramBehavioural
Enrolled participants will participate in an individual (one-on-one) Telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight sessions lasting 75 minutes each (except the first session which lasts 90 minutes) over a 3-month period.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Mindfulness Program | Experimental | Telehealth mindfulness sessions Receives: Behavioral: Telehealth Mindfulness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Proportion of eligible patients enrolled in study.
Measured: 3 months after discharge from emergency department
Feasibility - Retention
Proportion of enrolled participants who complete study.
Measured: 3 months after discharge from the emergency department.
Feasibility - Session attendance
Average number of sessions attended.
Measured: 3 months after discharge from the emergency department.
Secondary outcomes (6)
Patient satisfaction with treatment
Single item assessing satisfaction of overall results from telehealth mindfulness program.
Measured: Baseline and 3 months after discharge from the emergency department.
Patient Reported Outcomes Measurement Information System - Physical Function Short Form
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.
Measured: Baseline and 3 months after discharge from the emergency department.
Patient Reported Outcomes Measurement Information System - Pain Interference Short Form
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.
Measured: Baseline and 3 months after discharge from the emergency department.
Patient Reported Outcomes Measurement Information System - Pain Intensity
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.
Measured: Baseline and 3 months after discharge from the emergency department.
Self-reported opioid medication use
Average number of pills per day (name and dose specified) and covered to morphine equivalent dose.
Measured: Baseline and 3 months after discharge from the emergency department.
Self-reported return visits to the emergency department
Single item assessing return visits to emergency department.
Measured: 3 months after discharge from the emergency department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start5 Mar 2021
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Why it stopped: Difficulty with participant enrollment and intervention engagement.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT04783532
- Sponsor's protocol ID
- 202543
- Status last verified
- Aug 2022
- First submitted
- 26 Feb 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Telehealth Mindfulness Intervention to Improve Outcomes of Patients With an Acute Exacerbation of Chronic Back Pain Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT04783532
- Acronym / sponsor ID
- 202543
- Conditions
- Low Back Pain, Back Pain, Pain, Chronic Low-back Pain
- Keywords
- Mindfulness, Telehealth, Mindfulness-based intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with participant enrollment and intervention engagement.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 5 Mar 2021 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth Mindfulness Program | Experimental | Behavioral: Telehealth Mindfulness ProgramTelehealth mindfulness sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older;
- Presenting to the emergency department to address a chief complaint of an acute exacerbation of chronic low back pain;
- 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
- English-speaking due to feasibility of utilizing a telehealth mindfulness program developed in English
Key exclusion criteria (5 listed)
- Patients requiring hospitalization for a medical severe condition or comorbidity;
- 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;
- Patients with a history of multiple substance use or abuse;
- Patients involved in litigation related to the chronic pain condition; and
- 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).
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 |
|---|---|---|
| Telehealth Mindfulness ProgramEnrolled participants will participate in an individual (one-on-one) Telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight sessions lasting 75 minutes each (except the first session which lasts 90 minutes) over a 3-month period. | Behavioural | Telehealth Mindfulness Program |
Primary outcome
Feasibility - Recruitment
Time frame: 3 months after discharge from emergency department
Proportion of eligible patients enrolled in study.
Feasibility - Retention
Time frame: 3 months after discharge from the emergency department.
Proportion of enrolled participants who complete study.
Feasibility - Session attendance
Time frame: 3 months after discharge from the emergency department.
Average number of sessions attended.
6 secondary outcomes
Patient satisfaction with treatment
Time frame: Baseline and 3 months after discharge from the emergency department.
Patient Reported Outcomes Measurement Information System - Physical Function Short Form
Time frame: Baseline and 3 months after discharge from the emergency department.
Patient Reported Outcomes Measurement Information System - Pain Interference Short Form
Time frame: Baseline and 3 months after discharge from the emergency department.
Patient Reported Outcomes Measurement Information System - Pain Intensity
Time frame: Baseline and 3 months after discharge from the emergency department.
Self-reported opioid medication use
Time frame: Baseline and 3 months after discharge from the emergency department.
Self-reported return visits to the emergency department
Time frame: 3 months after discharge from the emergency department.
Results and safety
The study was stopped early (reason given: Difficulty with participant enrollment and intervention engagement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Mindfulness Program in people with Low Back Pain and Back Pain, run by Vanderbilt University Medical Center at 1 site 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 5 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: stopped early, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Difficulty with participant enrollment and intervention engagement.). Results are not available in the source record.
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 - Recruitment (time frame: 3 months after discharge from emergency department). The study lists 3 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 31 Aug 2022.