RECRUITING

Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma

Conditions

Orthopaedic Trauma Chronic Pain Musculoskeletal Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study

Quick Facts

Study Start:2024-08-28

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05989230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Rachel Aaron, PhD

CONTACT

410-502-2428

raaron4@jhmi.edu

Stephen Wegener, PhD

CONTACT

swegener@jhmi.edu

Principal Investigator

Rachel Aaron, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Rachel Aaron, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-08-28

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Orthopaedic Trauma
Chronic Pain
Musculoskeletal Injury