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New treatment option for Orthopaedic Trauma
Official title Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
ClinicalTrials.gov ID: NCT05989230
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.