Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes

NCT06360341 | Completed

• 1 other identifier: 202301946
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Low Back Pain, Mechanical; Acute Pain

Keywords

Pilot Randomized Controlled Trial; Digital Pain Self-Management Intervention; Improving Health Outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  12-weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive Emergency Department Digital Pain Self-Management Intervention (EDPSI) + routine discharge care (RC).

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).

Other: Routine Discharge Care

Interventions

Emergency Department Digital Pain Self-Management Intervention (EDPSI) BEHAVIORAL

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.

Intervention Group

Routine Discharge Care OTHER

Routine Discharge Care

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Admission to the hospital
• Disabilities that would inhibit digital intervention learning (medical, psychiatric, traumatic brain injury, concussion, blindness, or deaf)
• Prisoners/Incarcerated

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Emergency Centers

Gainesville, Florida, 32608, United States

Location

Related Publications (30)

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Related Links

• Pain self-efficacy questionnaire (PSEQ).
• FastStats - emergency department visits. Centers for Disease Control and Prevention.
• Understanding statistical power and significance testing - an interactive visualization.
• Back safety - statpearls - NCBI bookshelf.
• Emmi Educational Videos. Yale Health.

MeSH Terms

Conditions

Low Back Pain; Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandria A Carey, MSN, MBA

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: April 15, 2024
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: June 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)