Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic T… (NCT05989230) | Clinical Trial Compass
RecruitingNot Applicable
Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
United States30 participantsStarted 2024-08-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a talk therapy called Emotional Awareness and Expression Therapy for chronic pain after an orthopedic injury — is this type of psychological approach something that makes sense for my specific situation, or would physical rehabilitation or pain management come first?
2Since this study is in an early feasibility phase focused on whether the program can even be run successfully rather than proving it works, what does that mean for what I can realistically expect in terms of benefit compared to my current treatment options?
3The trial is measuring things like how many sessions patients actually attend and whether they're satisfied — can you help me understand what the therapy sessions actually involve week to week, and whether the time commitment would be realistic for my life right now?
4Because this focuses on emotional awareness and expression as a way to address persistent pain, do you think my pain situation has a component where this kind of mind-body approach might be worth exploring, or are there other causes of my pain that should be ruled out first?
5Are there standard treatments for chronic pain after orthopedic trauma that I should try before or alongside considering a feasibility study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Enrollment
Timeframe: 24 months
2
Feasibility of Retention
Timeframe: 24 months
3
Feasibility of Recruitment
Timeframe: 24 months
4
Percentage of patient session attendance
Timeframe: 8 weeks
5
Therapist Fidelity (Questionnaire developed by study team)
Timeframe: 8 Weeks
6
Percentage of patients who indicate patient satisfaction and acceptability