Low Back Pain, MechanicalNCT06360341
Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes
A study testing Emergency Department Digital Pain Self-Management Intervention (EDPSI) and Routine Discharge Care in people with Low Back Pain, Mechanical and Acute Pain, run by University of Florida at 1 site in United States.
Trial summary
The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Mechanical, Acute Pain
- What is being tested?
- Emergency Department Digital Pain Self-Management Intervention (EDPSI) and Routine Discharge Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 14 Oct 2024
- 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
- Patient subjective chief complaint of acute or subacute axial low back pain, low back injury, mechanical low back pain, non-specific low back pain, back sprain, or back strain Or
- Provider diagnosis of acute axial low back pain
- ICD-10 discharge codes:
- Low back pain, unspecified M54.50
- Pain of lumbar, acute, for less than 3 months; low back strain (S39.012)
- Unspecific injury of lower back, initial encounter (S39.92XA) And
Show all 12Show fewer
- Are aged 18 years and older
- Can read and consent to participate in the trial
- Can read and speak English
- Can complete study follow-up at prespecified intervals
- Have access to Wi-Fi
- Have access to a phone or other smart device (e.g. a smartphone, tablet, or computer) that would allow receiving of phone calls, text messages, Zoom meetings, or emails
Who cannot join
- Admission to the hospital
- Disabilities that would inhibit digital intervention learning (medical, psychiatric, traumatic brain injury, concussion, blindness, or deaf)
- Prisoners/Incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Emergency Centers
Gainesville, Florida, 32608
About this study
Official title: Feasibility and Acceptability of an Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes: A Pilot Randomized Controlled Trial
The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes.
Read the detailed description
Investigators:
Principal Investigator: Alexandria Carey (University of Florida, PhD Candidate) Co-Investigator/ Supervisory Chair: Ann Horgas
Supervisory Committee Members:
- Laurie Duckworth
- Hwayoung Cho
- Jason M. Beneciuk Previous Co-Investigator (2022-2024): Angela Starkweather
IRB #: 202301946
Study Site: UF Health Emergency Centers, campuses in Gainesville, Florida
Study Sponsor: University of Florida
Background/Significance: Over 3.4 million acute axial low back pain (aLBP) cases are treated annually in the United States (US) emergency departments (ED). ED patients with aLBP receive varying verbal and written discharge routine care (RC), leading to gaps in patient discharge effectiveness and effective self-management. Ineffective aLBP self-management may increase the risk of transition to chronic low back pain (cLPB), a chief cause of worldwide disability, with associated costs reaching > $60 million annually. This research will address this significant problem by evaluating an ED digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from aLBP to cLBP in ED patients discharged with axial aLBP. The proposed research has significant potential to increase self-efficacy, which is one of the most potent mechanisms of behavior change and improved health outcomes. Due to the focus on accessibility and usability, the intervention may reduce discharge disparities in aLBP self-management, especially among patients with low health literacy.
Study Questions: This research will answer the following questions: 1) Will an ED digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge retention, and skills progress patient self-management behaviors and health status?
Primary Objective: Primary Aims 1.1.1 Evaluate the feasibility and acceptability of an ED digital pain self-management intervention (EDPSI) for individuals aged 18 years and older presenting to the ED with acute axial low back pain (aLPB).
- Feasibility will be measured by appropriateness, relevance to the ED population, recruitment, retention, and engagement percentages using the following criteria:
- Of patients who meet eligibility criteria for the study, >80% will voluntarily consent to participate in the study.
- Of patients consented to the study, >80% will complete the 1-week follow up measures.
- Of patients randomized to the intervention group, >70% will attend booster sessions at 2 and 8 weeks.
- Of patients randomized to the intervention group, >80% will recall the discharge video content during booster sessions at 2 and 8 weeks.
- Acceptability of the intervention will be evaluated using the Preference and Satisfaction Questionnaire (EPSQ) and Patient Satisfaction and Healthcare Utilization Questionnaire (PSHU) post-intervention and the following criteria:
- Of patients who complete the study, >80% will rate the intervention as "satisfactory" or "highly satisfactory"
- Of patients who complete the study, >80% would be willing to refer a friend or family member with acute low back pain to the intervention.
- Of overall patients who complete the study, >80% would be satisfied with study participation and be willing to recommend the study.
1.1.2 Evaluate the preliminary clinical efficacy of the EDPSI on participant's self-management, pain self-efficacy, severity, and interference. Self-management, defined as participant engagement in self-management behaviors and integration into lifestyle by acknowledging confidence and demonstrating knowledge retainment and skills in managing to perform everyday activities while in acute pain. Preliminary clinical efficacy would be assessed using estimates of Minimal Clinically Important Difference (MCID), the smallest change in an outcome that patients perceive as meaningful and indicative of improvement.
- Self-management (self-efficacy, knowledge, and skills) preliminary clinical efficacy (MCID) will be measured using the 13-item Patient Activation Measure (PAM) at 1-week, 6-weeks, and 12-weeks.
- Self-efficacy (confidence) preliminary clinical efficacy (MCID) will be measured using the Pain Self-Efficacy Questionnaire (PSEQ) at 1-week, 6-weeks, and 12-weeks.
- Pain severity and interference preliminary clinical efficacy (MCID) will be measured using the Brief Pain Inventory-Short Form (BPI-SF) at 1-week, 6-weeks, and 12-weeks.
Methods: The proposed phased study will use a two-group pilot randomized controlled trial design to enroll 30 individuals who have been seen in the ED with aLBP. Participants will be randomized into RC or RC + EDPSI and receive follow-up surveys for 12-weeks post-intervention. The intervention group will also receive Booster sessions via Zoom with the principal investigator to assess and reinforce their knowledge retention of techniques and provide return demonstration reinforcement ergonomics and range of motion movements demonstrated, in weeks two and eight.
Outcome Measures: All participants will be followed for 12-weeks assessing self-management and self-efficacy in weeks 1, 6, and 12. Feasibility will be measured by recruitment, enrollment, and retention percentages. Acceptability and education satisfaction will be measured using the Education-Preference and Satisfaction Questionnaire (EPSQ) post-intervention. Self-management sustainment will be measured including PSEQ, PAM, and patient satisfaction and healthcare utilization (PSHU) requesting patient overall satisfaction, additional healthcare utilization, and pain management related to continued back pain or complications post-injury.
- Conditions
- Low Back Pain, Mechanical, Acute Pain
- Being tested
- Emergency Department Digital Pain Self-Management Intervention (EDPSI), Routine Discharge Care
- Keywords
- Pilot Randomized Controlled Trial, Digital Pain Self-Management Intervention, Improving Health Outcomes
- Medical subject headings
- Low Back Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Department Digital Pain Self-Management Intervention (EDPSI)Behavioural
The EDPSI is a developed supplemental digital video for patients presenting to the emergency department with acute low back pain (aLBP). The content consists of self-management approaches for diverse adult patient preferences including biopsychosocial contributors to pain and clinical practice guidelines to self-management options. Highlights of the discharge instructions summary include follow-up with provider, red flag warnings, and medication safety. Actor demonstration of ergonomics and range of motion movements provide application of Physical Therapy (PT)-based preventative strategies. Combination therapies including PT counseling, complementary alternative medicine (acupuncture, massage, yoga, or Pilates), and use of and safety with ice or heat thermal therapies. Active participation, stress management, and involvement of support systems are addressed.
Routine Discharge CareOther
Routine Discharge Care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive Emergency Department Digital Pain Self-Management Intervention (EDPSI) + routine discharge care (RC). Receives: Behavioral: Emergency Department Digital Pain Self-Management Intervention (EDPSI); Other: Routine Discharge Care |
| Control Group | Active comparator | The control group will receive routine discharge care (RC). Receives: Other: Routine Discharge Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving Self-Management Health Outcomes
Feasibility and Acceptability of the pilot study will assess recruitment, retention, engagement, satisfaction, and willingness to recommend. Acceptability and intervention satisfaction will be assessed using the Education Preference and Satisfaction Questionnaire (EPSQ) and study satisfaction and recommendation using the Patient Satisfaction and Healthcare Utilization Questionnaire (PSHU). Preliminary Clinical Efficacy will be assessed for self-management, self-efficacy, pain severity and interference. Self-management will be assessed using the short 13-item Patient Activation Measure (PAM), self-efficacy using the Pain Self-Efficacy Questionnaire (PSEQ), pain severity and interference using the Brief Pain Inventory Short-Form (BPI-SF). Preliminary clinical efficacy of the EDPSI for adults with aLBP will be evaluated using estimates of Minimal Clinically Important Difference (MCID), the smallest change in an outcome that patients perceive as meaningful and indicative of improvement.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Apr 2024
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandria A Carey, MSN, MBA, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360341
- Sponsor's protocol ID
- 202301946
- Status last verified
- Nov 2024
- First submitted
- 8 Apr 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Integrity and Oversight: The PI will be responsible for the ethical conduct of the study by all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB. Data Management: Subject confidentiality is strictly held in trust by the investigators and study staff. All written informed consent forms will be immediately secured in the locked and secured office of the PI in a locked and secured study-designated cabinet in the College of Nursing Room 2203. Study data collection and instrument administration will be conducted via REDCap, a secure, web-based application designed to support data capture, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical Packages; and 4) procedures for importing data from external sources. REDCap has built-in measures to protect participants' anonymity.
Publications
Anderson JK, Wallace LM. Evaluation of uptake and effect on patient-reported outcomes of a clinician and patient co-led chronic musculoskeletal pain self-management programme provided by the UK National Health Service. Br J Pain. 2018 May;12(2):104-112. doi: 10.1177/2049463717734015. Epub 2017 Sep 26.
PubMed 29796262Baker TL, Greiner JV. Guidelines: Discharge Instructions for Covid-19 Patients. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211024400. doi: 10.1177/21501327211024400.
PubMed 34142617Boden-Albala B, Goldmann E, Parikh NS, Carman H, Roberts ET, Lord AS, Torrico V, Appleton N, Birkemeier J, Parides M, Quarles L. Efficacy of a Discharge Educational Strategy vs Standard Discharge Care on Reduction of Vascular Risk in Patients With Stroke and Transient Ischemic Attack: The DESERVE Randomized Clinical Trial. JAMA Neurol. 2019 Jan 1;76(1):20-27. doi: 10.1001/jamaneurol.2018.2926.
PubMed 30304326Chidume T, Pass-Ivy S. Student-Novice Nurse Preparation: Addressing Barriers in Discharge Teaching. Nurs Educ Perspect. 2020 Mar/Apr;41(2):88-91. doi: 10.1097/01.NEP.0000000000000498.
PubMed 31107815DeSai C, Janowiak K, Secheli B, Phelps E, McDonald S, Reed G, Blomkalns A. Empowering patients: simplifying discharge instructions. BMJ Open Qual. 2021 Sep;10(3):e001419. doi: 10.1136/bmjoq-2021-001419.
PubMed 34521621Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.
PubMed 24787228Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.
PubMed 34963996Edwards J, Hayden J, Asbridge M, Magee K. The prevalence of low back pain in the emergency department: a descriptive study set in the Charles V. Keating Emergency and Trauma Centre, Halifax, Nova Scotia, Canada. BMC Musculoskelet Disord. 2018 Aug 23;19(1):306. doi: 10.1186/s12891-018-2237-x.
PubMed 30134874George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
PubMed 34719942Gilmore AK, Walsh K, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. Prescription Opioid Misuse After a Recent Sexual Assault: A Randomized Clinical Trial of a Video Intervention. Am J Addict. 2019 Sep;28(5):376-381. doi: 10.1111/ajad.12922. Epub 2019 Jun 26.
PubMed 31242340Gold JM, Chadwick W, Gustafson M, Valenzuela Riveros LF, Mello A, Nasr A. Parent Perceptions and Experiences Regarding Medication Education at Time of Hospital Discharge for Children With Medical Complexity. Hosp Pediatr. 2020 Aug;10(8):679-686. doi: 10.1542/hpeds.2020-0078.
PubMed 32737165Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
PubMed 16336556Hodges R, Stepien S, Kim LY. Quality Improvement: Using Teach-Back to Improve Patient Satisfaction during Discharge in the Emergency Department. J Emerg Nurs. 2021 Nov;47(6):870-878. doi: 10.1016/j.jen.2021.05.006. Epub 2021 Jun 30.
PubMed 34215436Hoek AE, Geraerds AJLM, Rood PPM, Joosten M, Dippel DWJ, van Beeck EF, van den Hengel L, Dijkstra B, Papathanasiou D, van Rijssel D, van den Hamer M, Schuit SCE, Burdorf A, Haagsma JA, Polinder S. The Effect of Written and Video Discharge Instructions After Mild Traumatic Brain Injury on Healthcare Costs and Productivity Costs. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):E231-E241. doi: 10.1097/HTR.0000000000000720. Epub 2021 Jul 26.
PubMed 34320553In J. Introduction of a pilot study. Korean J Anesthesiol. 2017 Dec;70(6):601-605. doi: 10.4097/kjae.2017.70.6.601. Epub 2017 Nov 14.
PubMed 29225742
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06360341
- Acronym / sponsor ID
- 202301946
- Conditions
- Low Back Pain, Mechanical, Acute Pain
- Keywords
- Pilot Randomized Controlled Trial, Digital Pain Self-Management Intervention, Improving Health Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 11 Apr 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 proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes.
Detailed description
Investigators:
Principal Investigator: Alexandria Carey (University of Florida, PhD Candidate) Co-Investigator/ Supervisory Chair: Ann Horgas
Supervisory Committee Members:
- Laurie Duckworth
- Hwayoung Cho
- Jason M. Beneciuk Previous Co-Investigator (2022-2024): Angela Starkweather
IRB #: 202301946
Study Site: UF Health Emergency Centers, campuses in Gainesville, Florida
Study Sponsor: University of Florida
Background/Significance: Over 3.4 million acute axial low back pain (aLBP) cases are treated annually in the United States (US) emergency departments (ED). ED patients with aLBP receive varying verbal and written discharge routine care (RC), leading to gaps in patient discharge effectiveness and effective self-management. Ineffective aLBP self-management may increase the risk of transition to chronic low back pain (cLPB), a chief cause of worldwide disability, with associated costs reaching > $60 million annually. This research will address this significant problem by evaluating an ED digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from aLBP to cLBP in ED patients discharged with axial aLBP. The proposed research has significant potential to increase self-efficacy, which is one of the most potent mechanisms of behavior change and improved health outcomes. Due to the focus on accessibility and usability, the intervention may reduce discharge disparities in aLBP self-management, especially among patients with low health literacy.
Study Questions: This research will answer the following questions: 1) Will an ED digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge retention, and skills progress patient self-management behaviors and health status?
Primary Objective: Primary Aims 1.1.1 Evaluate the feasibility and acceptability of an ED digital pain self-management intervention (EDPSI) for individuals aged 18 years and older presenting to the ED with acute axial low back pain (aLPB).
- Feasibility will be measured by appropriateness, relevance to the ED population, recruitment, retention, and engagement percentages using the following criteria:
- Of patients who meet eligibility criteria for the study, >80% will voluntarily consent to participate in the study.
- Of patients consented to the study, >80% will complete the 1-week follow up measures.
- Of patients randomized to the intervention group, >70% will attend booster sessions at 2 and 8 weeks.
- Of patients randomized to the intervention group, >80% will recall the discharge video content during booster sessions at 2 and 8 weeks.
- Acceptability of the intervention will be evaluated using the Preference and Satisfaction Questionnaire (EPSQ) and Patient Satisfaction and Healthcare Utilization Questionnaire (PSHU) post-intervention and the following criteria:
- Of patients who complete the study, >80% will rate the intervention as "satisfactory" or "highly satisfactory"
- Of patients who complete the study, >80% would be willing to refer a friend or family member with acute low back pain to the intervention.
- Of overall patients who complete the study, >80% would be satisfied with study participation and be willing to recommend the study.
1.1.2 Evaluate the preliminary clinical efficacy of the EDPSI on participant's self-management, pain self-efficacy, severity, and interference. Self-management, defined as participant engagement in self-management behaviors and integration into lifestyle by acknowledging confidence and demonstrating knowledge retainment and skills in managing to perform everyday activities while in acute pain. Preliminary clinical efficacy would be assessed using estimates of Minimal Clinically Important Difference (MCID), the smallest change in an outcome that patients perceive as meaningful and indicative of improvement.
- Self-management (self-efficacy, knowledge, and skills) preliminary clinical efficacy (MCID) will be measured using the 13-item Patient Activation Measure (PAM) at 1-week, 6-weeks, and 12-weeks.
- Self-efficacy (confidence) preliminary clinical efficacy (MCID) will be measured using the Pain Self-Efficacy Questionnaire (PSEQ) at 1-week, 6-weeks, and 12-weeks.
- Pain severity and interference preliminary clinical efficacy (MCID) will be measured using the Brief Pain Inventory-Short Form (BPI-SF) at 1-week, 6-weeks, and 12-weeks.
Methods: The proposed phased study will use a two-group pilot randomized controlled trial design to enroll 30 individuals who have been seen in the ED with aLBP. Participants will be randomized into RC or RC + EDPSI and receive follow-up surveys for 12-weeks post-intervention. The intervention group will also receive Booster sessions via Zoom with the principal investigator to assess and reinforce their knowledge retention of techniques and provide return demonstration reinforcement ergonomics and range of motion movements demonstrated, in weeks two and eight.
Outcome Measures: All participants will be followed for 12-weeks assessing self-management and self-efficacy in weeks 1, 6, and 12. Feasibility will be measured by recruitment, enrollment, and retention percentages. Acceptability and education satisfaction will be measured using the Education-Preference and Satisfaction Questionnaire (EPSQ) post-intervention. Self-management sustainment will be measured including PSEQ, PAM, and patient satisfaction and healthcare utilization (PSHU) requesting patient overall satisfaction, additional healthcare utilization, and pain management related to continued back pain or complications post-injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Emergency Department Digital Pain Self-Management Intervention (EDPSI), Other: Routine Discharge CareThe intervention group will receive Emergency Department Digital Pain Self-Management Intervention (EDPSI) + routine discharge care (RC). |
| Control Group | Active comparator | Other: Routine Discharge CareThe control group will receive routine discharge care (RC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient subjective chief complaint of acute or subacute axial low back pain, low back injury, mechanical low back pain, non-specific low back pain, back sprain, or back strain Or
- Provider diagnosis of acute axial low back pain
- ICD-10 discharge codes:
- Low back pain, unspecified M54.50
- Pain of lumbar, acute, for less than 3 months; low back strain (S39.012)
Key exclusion criteria (3 listed)
- Admission to the hospital
- Disabilities that would inhibit digital intervention learning (medical, psychiatric, traumatic brain injury, concussion, blindness, or deaf)
- Prisoners/Incarcerated
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 |
|---|---|---|
| Emergency Department Digital Pain Self-Management Intervention (EDPSI)The EDPSI is a developed supplemental digital video for patients presenting to the emergency department with acute low back pain (aLBP). The content consists of self-management approaches for diverse adult patient preferences including biopsychosocial contributors to pain and clinical practice guidelines to self-management options. Highlights of the discharge instructions summary include follow-up with provider, red flag warnings, and medication safety. Actor demonstration of ergonomics and range of motion movements provide application of Physical Therapy (PT)-based preventative strategies. Combination therapies including PT counseling, complementary alternative medicine (acupuncture, massage, yoga, or Pilates), and use of and safety with ice or heat thermal therapies. Active participation, stress management, and involvement of support systems are addressed. | Behavioural | Intervention Group |
| Routine Discharge CareRoutine Discharge Care | Other | Control Group, Intervention Group |
Primary outcome
Improving Self-Management Health Outcomes
Time frame: 12-weeks
Feasibility and Acceptability of the pilot study will assess recruitment, retention, engagement, satisfaction, and willingness to recommend. Acceptability and intervention satisfaction will be assessed using the Education Preference and Satisfaction Questionnaire (EPSQ) and study satisfaction and recommendation using the Patient Satisfaction and Healthcare Utilization Questionnaire (PSHU). Preliminary Clinical Efficacy will be assessed for self-management, self-efficacy, pain severity and interference. Self-management will be assessed using the short 13-item Patient Activation Measure (PAM), self-efficacy using the Pain Self-Efficacy Questionnaire (PSEQ), pain severity and interference using the Brief Pain Inventory Short-Form (BPI-SF). Preliminary clinical efficacy of the EDPSI for adults with aLBP will be evaluated using estimates of Minimal Clinically Important Difference (MCID), the smallest change in an outcome that patients perceive as meaningful and indicative of improvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 29796262Anderson JK, Wallace LM. Evaluation of uptake and effect on patient-reported outcomes of a clinician and patient co-led chronic musculoskeletal pain self-management programme provided by the UK National Health Service. Br J Pain. 2018 May;12(2):104-112. doi: 10.1177/2049463717734015. Epub 2017 Sep 26.
- Background: PubMed 34142617Baker TL, Greiner JV. Guidelines: Discharge Instructions for Covid-19 Patients. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211024400. doi: 10.1177/21501327211024400.
- Background: PubMed 30304326Boden-Albala B, Goldmann E, Parikh NS, Carman H, Roberts ET, Lord AS, Torrico V, Appleton N, Birkemeier J, Parides M, Quarles L. Efficacy of a Discharge Educational Strategy vs Standard Discharge Care on Reduction of Vascular Risk in Patients With Stroke and Transient Ischemic Attack: The DESERVE Randomized Clinical Trial. JAMA Neurol. 2019 Jan 1;76(1):20-27. doi: 10.1001/jamaneurol.2018.2926.
- Background: PubMed 31107815Chidume T, Pass-Ivy S. Student-Novice Nurse Preparation: Addressing Barriers in Discharge Teaching. Nurs Educ Perspect. 2020 Mar/Apr;41(2):88-91. doi: 10.1097/01.NEP.0000000000000498.
- Background: PubMed 34521621DeSai C, Janowiak K, Secheli B, Phelps E, McDonald S, Reed G, Blomkalns A. Empowering patients: simplifying discharge instructions. BMJ Open Qual. 2021 Sep;10(3):e001419. doi: 10.1136/bmjoq-2021-001419.
- Background: PubMed 24787228Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.
- Background: PubMed 34963996Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.
- Background: PubMed 30134874Edwards J, Hayden J, Asbridge M, Magee K. The prevalence of low back pain in the emergency department: a descriptive study set in the Charles V. Keating Emergency and Trauma Centre, Halifax, Nova Scotia, Canada. BMC Musculoskelet Disord. 2018 Aug 23;19(1):306. doi: 10.1186/s12891-018-2237-x.
- Background: PubMed 34719942George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
- Background: PubMed 31242340Gilmore AK, Walsh K, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. Prescription Opioid Misuse After a Recent Sexual Assault: A Randomized Clinical Trial of a Video Intervention. Am J Addict. 2019 Sep;28(5):376-381. doi: 10.1111/ajad.12922. Epub 2019 Jun 26.
- Background: PubMed 32737165Gold JM, Chadwick W, Gustafson M, Valenzuela Riveros LF, Mello A, Nasr A. Parent Perceptions and Experiences Regarding Medication Education at Time of Hospital Discharge for Children With Medical Complexity. Hosp Pediatr. 2020 Aug;10(8):679-686. doi: 10.1542/hpeds.2020-0078.
- Background: PubMed 16336556Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
- Pain self-efficacy questionnaire (PSEQ).Link provided by the sponsor.
- Understanding statistical power and significance testing - an interactive visualization.Link provided by the sponsor.
- Back safety - statpearls - NCBI bookshelf.Link provided by the sponsor.
- Emmi Educational Videos. Yale Health.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data Integrity and Oversight: The PI will be responsible for the ethical conduct of the study by all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB. Data Management: Subject confidentiality is strictly held in trust by the investigators and study staff. All written informed consent forms will be immediately secured in the locked and secured office of the PI in a locked and secured study-designated cabinet in the College of Nursing Room 2203. Study data collection and instrument administration will be conducted via REDCap, a secure, web-based application designed to support data capture, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical Packages; and 4) procedures for importing data from external sources. REDCap has built-in measures to protect participants' anonymity.
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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.
Alexandria A Carey, MSN, MBA principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Department Digital Pain Self-Management Intervention (EDPSI) and Routine Discharge Care in people with Low Back Pain, Mechanical and Acute Pain, run by University of Florida 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 12 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: finished, as of the sponsor's last update on 27 Jun 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improving Self-Management Health Outcomes (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360341, which also lists 30 linked publications.
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 27 Jun 2025.