Clinical trial NCT03077919: Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Effectiveness
Official title: A Randomized, Sham-procedure-controlled, Blinded Study to Evaluate the Effectiveness and Acceptability of Right-sided Stellate Ganglion Block for Treatment of Posttraumatic Stress Disorder Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PostTraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Generalized Anxiety Disorder
Depression
Distress
Alcohol Use
Pain
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Womack Army Medical Center
name: Tripler Army Medical Center
name: Landstuhl Regional Medical Center
First posted: 2017-03-13
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be centrally randomized to 2:1 active:sham SGB and will be evaluated at Womack Army Medical Center in North Carolina, Tripler Army Medical Center in Hawaii, and Landstuhl Regional Medical Center in Germany. Randomization will be stratified by site so that each will have a 2:1 active:sham ratio. The target population includes active-duty service members and study duration is 10 weeks in the clinical effectiveness trial for which an enrollment of 240 participants is planned.
Primary purpose: TREATMENT

Brief summary: This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the efficacy of right-sided stellate ganglion block (SGB) on the acute symptomatology of Post traumatic Stress Disorder (PTSD), evaluated by the Clinician-Administered PTSD Scale (CAPS-5) clinical interview at pre-treatment and at 8 weeks. This entry describes the effectiveness study.The acceptability study is described in a separate entry.

Detailed description: Study intervention will be administered at week 0 and at week 2. Injections will be performed under ultrasound visualization. The study medication will be either 7-10 mL 0.5% ropivacaine injected ventral to the right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia at the level of the C6 anterior tubercle (landmarks for the stellate ganglion) (active study medication) or 1-2 mL preservative free normal saline injected anterolateral to the anterior tubercle of C6 (sham procedure). The participant will not be informed which treatment he or she has received and the interaction of the participant and treating physician will be scripted as much as possible. Following the intervention, the treating physician should have no further contact with the participant except as required for participant safety.

Participants will be evaluated for posttraumatic stress disorder (PTSD) symptomatology prior to week 0 and at 8 weeks using the Diagnostic and Statistical Manual (DSM-5) Clinician-Administered PTSD Scale (CAPS-5). They will complete the PTSD Checklist for DSM-5 (PCL-5), the PTSD Checklist - Civilian Version (PCL-C), and the Mini-international Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 0, 2, 4, 6, and 8 weeks; they also will complete the M.I.N.I.-Plus items at screening. The 12 item short form survey (SF-12), generalized anxiety disorder 7-item (GAD-7), patient health questionnaire (PHQ-9), K6, Alcohol Use Disorder Identification Test (AUDIT-C/AUDIT), and a short pain scale will be completed at weeks 0, 4, and 8.

Data collected at baseline and 8 weeks will be the primary focus of data analysis. Data collected at other time points will be analyzed as appropriate.

Eligibility criteria: Inclusion Criteria:

* Member of the Army on active duty status
* Personal access to Internet
* Anticipated stable assignment to installation for at least 2 months
* Stable dosing for ≥3 months, if receiving psychotropic medications
* Prior to enrollment, offered PTSD treatment using A-level modality (as defined by U.S. Army Medical Command (MEDCOM) policy 14-094; 18 Dec 2014).
* PTSD Checklist - Civilian (PCL-C) score of 32 or greater at screening
* Acceptable clinically indicated preoperative laboratory studies, per standard site-specific protocols

Exclusion Criteria:

* Prior Stellate Ganglion Block (SGB)
* Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
* Pregnancy (evaluated by urine test pre-procedure)
* Current anticoagulant use
* History of a bleeding disorder
* Infection or mass at injection site
* Myocardial infarction within 6 months of procedure
* Phrenic or laryngeal nerve palsy (hoarseness)
* History of glaucoma
* History of schizophrenia, other psychotic disorder, bipolar disorder, or personality disorder (axis 2)
* Moderate or severe traumatic brain injury
* Symptoms of moderate to severe substance use disorder in past 30 days
* Suicidal ideation in the past 2 months, documented by the M.I.N.I.-Plus Suicidality Items
* Any ongoing other major life stressor or condition not listed here that the site Investigator believes clearly would place the participant at risk for injury or a poor outcome

Primary outcomes:
measure: Clinician Administered PTSD Score (CAPS-5) TSSS
timeFrame: Baseline, 8-weeks
Secondary outcomes:
measure: PTSD Checklist (PCL-5)
timeFrame: Baseline, 8-weeks
measure: PTSD Checklist Civilian (PCL-C)
timeFrame: Baseline, 8-weeks
measure: Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items
timeFrame: Baseline, 8-weeks
measure: Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C)
timeFrame: Baseline, 8-weeks
measure: Kessler Psychiatric Distress Scale (K6)
timeFrame: Baseline, 8-weeks
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 8-weeks
measure: Generalized Anxiety Disorder 7-item Survey (GAD-7)
timeFrame: Baseline, 8-weeks
measure: 12-item Short Form Survey (SF-12) of Physical Functioning
timeFrame: Baseline, 8-weeks
measure: Short Pain Scale
timeFrame: Baseline, 8-weeks
measure: Current Medications
timeFrame: Baseline, 8-weeks
measure: 12 Item Short Form Survey (SF-12) of Mental Functioning
timeFrame: Baseline, 8-weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Tripler Army Medical Center (TAMC)
state: Hawaii
city: Fort Bragg
country: United States
facility: Womack Army Medical Center (WAMC)
state: North Carolina
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center (LRMC)
Study officials:
References:
citation: Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.