Neck Pain Clinical Trial
Official title:
Healing With Venlafaxine After Injury: A Randomized Clinical Trial of Venlafaxine Following Motor Vehicle Collision
Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine
administration in reducing acute and chronic musculoskeletal pain in individuals presenting
to the ED for evaluation after motor vehicle collision.
Participants: Participants will consist of 60 patients between the ages of 18-50 who present
to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain
score > 6 will be screened for further eligibility.
Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60
high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of
venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed
during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6
weeks, 4 months, and 6 months post-MVC.
Results from both animal and human studies suggest that treatment with the
serotonin-norepinephrine reuptake inhibitor (SNRIs) venlafaxine may reduce post-MVC pain. In
addition, venlafaxine has been shown to be beneficial in reducing posttraumatic stress
disorder (PTSD) symptoms, and in some patients PTSD symptoms may contribute to reinforcing
pain persistence after trauma.
This phase IIB pilot trial will screen patients presenting to the ED after MVC for the
presence of severe axial pain (>4 on a 0-10 numeric rating scale). Sixty of these "high
risk" patients will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine
to decrease acute and persistent musculoskeletal axial pain will be assessed.
Results will be used to design a large-scale RCT assessing the efficacy of venlafaxine
intervention in decreasing acute and persistent musculoskeletal pain in high-risk patients
presenting to the ED after minor MVC.
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