Nine Months of Fluoxetine Aids in the Reduction of Posttraumatic Stress Symptoms following a Traumatic Musculoskeletal Injury: A Randomized Controlled Trial

Abstract

OBJECTIVES: – To determine whether Fluoxetine, prescribed by orthopaedic providers during the immediate post-traumatic period, can lessen post-traumatic stress symptoms in survivors of traumatic musculoskeletal injuries. METHODS: – Design: Non-Blinded Prospective Randomized Clinical Trial. Setting: – Single Academic Level 1 Trauma Center. Patient Selection Criteria: – From July 2021 to December 2023, orthopaedic surgical patients admitted for a high-energy musculoskeletal trauma (injuries not resulting from a ground level fall or less) were randomized to receive 9 months of Fluoxetine (Prozac®) or Placebo (Calcium). Outcome measures and comparisons: – Outcomes were collected five times over the course of one year (2 weeks, 6 weeks, 3 months, 6 months, and 12 months). Patient-reported outcome measures evaluated depression (Beck Depression Inventory, BDI-II), anxiety (Beck Anxiety Inventory, BAI), Post-Traumatic Stress Disorder (PTSD) (PTSD Scale-Self report for DSM-5, PSS-SR), sleep (Pittsburgh Sleep Quality Index, PSQI), pain ( Pain, Enjoyment, General Activity Scale, PEG), and social enjoyment (PROMIS – Ability to participate Social, and PROMIS – Social Isolation ). RESULTS: – The two groups (Fluoxetine = 33, Calcium = 35) were similar in terms of age (Fluoxetine = 43.5 years (SD 15.8, range = 18-73), Calcium = 40.3 years (SD 17.7, range18-70 )) and sex (Fluoxetine =14 females, Calcium = 15 females). Subjects randomized to fluoxetine showed an improvement in PTSD symptoms over time (estimate = -0.2, 95%: -0.4, -0.0; with negative numbers indicating lessening symptoms), while those randomized to calcium exhibited little to no change (estimate = 0.1, 95%: -0.1, 0.3). Additionally, subjects in the fluoxetine group (estimate = -0.1, 95% CI: -0.1, -0.0, negative numbers indicating a decrease in pain) showed a significant improvement in pain over time, whereas the calcium group showed no significant change (estimate = -0.0, 95% CI: -0.0, 0.0). There were no significant changes over time in BDI scores (F1, 159 = 0.0, p = 0.9), BAI scores (F1, 169.4 = 0.0, p = 0.9), or PROMIS measure Social Isolation (F1, 142.9 = 0.5, p = 0.5). CONCLUSIONS: – Nine months of fluoxetine following a traumatic musculoskeletal injury decreased the severity of post-traumatic stress symptoms and pain throughout the recovery period. Level of Evidence: – Level II