Pain management · 2026
Multi-center, randomized controlled efficacy and comparative-effectiveness study evaluating ketamine, stellate ganglion blocks, combination treatment, and sham treatments for posttraumatic stress disorder and traumatic brain injury-associated headache: a study protocol.
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Cohen Steven P, Smolynets Roman, Wood Jordan, Singh Vinita, Gelfand Harold J, Park Edward J, Rodriguez Stephen E, Harcum Stacey, Ermer Elsa, Dodd Lauren D, King David B, Ross Jason, Khan Dost, Nader Antoun M, Pasquina Paul F, Brody David L
Аннотация
BACKGROUND: Posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) are conditions that share common mechanisms and are highly co-prevalent with each other and chronic pain. This pragmatic study will compare ketamine infusions to stellate ganglion blocks (SGB), their combination, and a placebo-sham-controlled arm.
METHODS: A double-blind study conducted at 3 U.S. and Ukrainian sites will be performed. Two hundred ten patients with PTSD and/or TBI-associated headache will be allocated in a 2:2:2:1 ratio to receive SGB/placebo ketamine, ketamine/sham SGB, ketamine/SGB, and placebo/sham. The bivariate co-primary outcome will evaluate change in Headache Impact Test and PTSD Checklist depending on diagnosis, at 4 weeks. Participants who experience a positive binary outcome will remain in the study through 6 months or until their outcome becomes negative.
DISCUSSION: Because PTSD and TBI have no discrete pathophysiological mechanisms and are co-prevalent with pain and psychopathology, they are associated with poor outcomes, polypharmacy, and high non-adherence rates, indicating a need for minimally invasive treatments that obviate these barriers. Whereas both therapies have evidence underpinning efficacy, results in clinical trials are conflicting. This study will provide real-world evidence in generalizable populations on the efficacy and comparative-effectiveness of ketamine and SGB, alone and in combination, with the possibility of changing clinical guidelines.
CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT06608277.
METHODS: A double-blind study conducted at 3 U.S. and Ukrainian sites will be performed. Two hundred ten patients with PTSD and/or TBI-associated headache will be allocated in a 2:2:2:1 ratio to receive SGB/placebo ketamine, ketamine/sham SGB, ketamine/SGB, and placebo/sham. The bivariate co-primary outcome will evaluate change in Headache Impact Test and PTSD Checklist depending on diagnosis, at 4 weeks. Participants who experience a positive binary outcome will remain in the study through 6 months or until their outcome becomes negative.
DISCUSSION: Because PTSD and TBI have no discrete pathophysiological mechanisms and are co-prevalent with pain and psychopathology, they are associated with poor outcomes, polypharmacy, and high non-adherence rates, indicating a need for minimally invasive treatments that obviate these barriers. Whereas both therapies have evidence underpinning efficacy, results in clinical trials are conflicting. This study will provide real-world evidence in generalizable populations on the efficacy and comparative-effectiveness of ketamine and SGB, alone and in combination, with the possibility of changing clinical guidelines.
CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT06608277.