Status:
RECRUITING
Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Orthopaedic Trauma
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this single-arm trial is to determine the feasibility of emotional awareness and expression therapy (EAET) for individuals with persistent pain following orthopedic trauma. As part of t...
Detailed Description
Orthopedic trauma, resulting in severe injuries such as multiple fractures or amputation, occurs in approximately 3 million people annually in the United States; about half of these people experience ...
Eligibility Criteria
Inclusion
- One or more acute orthopedic injuries
- The patient sustained an orthopedic injury including, but not limited to:
- Pelvic or acetabulum fracture
- Open/displaced comminuted fracture of long bones
- Upper extremity injuries with a major nerve involvement
- Injuries with significant injuries to major blood vessels
- Traumatic amputation of big toe, thumb, or proximal to the wrist or ankle.
- Initial admission to the trauma or orthopedic center/service of the participating hospital OR all necessary screening and patient characteristic data available in medical record (determination based on information available at time of enrollment)
- 18 years old or older
- Received operative fixation for at least one acute orthopaedic injury at a participating hospital. Patients should be recruited at the time of primary injury, not revision or complication surgery
- Average Brief Pain Inventory Score \> 3/10
- Presence of pain most days (\> 3 days/week) for past three months
Exclusion
- peri-prosthetic fractures of the femur (regardless of etiology)
- non-ambulatory due to an associated spinal cord injury
- non-ambulatory pre-injury
- currently pregnant
- moderate or severe traumatic brain injury (TBI), as evidenced by intracranial hemorrhage present on admission CT
- major amputation(s) of the upper or lower extremities
- non-English speaking
- Likely to have severe problems with maintaining follow-up for any of the following reasons:
- The patient has been diagnosed with a severe psychiatric conditions
- The patient has current alcohol and/or drug addiction based on medical record or patient self-report.
- The patient is intellectually challenged without adequate family support
- The patient lives outside the hospital's catchment area
- The patient follow-up is planned at another medical center
- The patient is a prisoner
- The patient is homeless
- Other
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05989230
Start Date
August 28 2024
End Date
February 1 2028
Last Update
December 18 2025
Active Locations (1)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287