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NCT05989230
Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
Conditions: Orthopaedic Trauma, Chronic Pain, Musculoskeletal Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Johns Hopkins University
Location: Johns Hopkins School of Medicine Baltimore Maryland
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 this study, participants will be asked to attend weekly EAET treatment sessions and complete assessments (including pre-treatment, post-treatment, and follow-up) consisting of questionnaires and sensory testing procedures.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT05989230). StuddyBuddy aggregates publicly available trial information.