Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Effectiveness

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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PostTraumatic Stress Disorder

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Sham treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stellate Ganglion Block (SGB)<br>7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to 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 stellate ganglion). | Drug: Ropivacaine<br>* 0.5% ropivacaine<br>* Other names: Naropin;|
| Sham Comparator: Sham Treatment<br>1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. | Drug: Sham treatment<br>* preservative-free normal saline<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Score (CAPS-5) TSSS | ≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD). | Baseline, 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist (PCL-5) | to evaluate symptoms measured by PTSD Checklist (PCL-5) at baseline; On the PCL 5, the range is 0 to 80, with higher scores indicating worse PTSD symptomatology. | Baseline, 8-weeks | 
| PTSD Checklist Civilian (PCL-C) | to evaluate symptoms measured by PTSD Checklist Civilian (PCL-C) at baseline; The total symptom severity score ranges from 17 to 85. The higher the score, the more severe the PTSD symptomatology | Baseline, 8-weeks | 
| Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 8 weeks. The higher the score, the more severe the pathology. If an individual answers yes to any of seven initial questions concerning suicidal ideation in the past two months, they are asked an additional four questions regarding current suicidal ideation. Any positive answer on these four current questions triggers an automated alert system. | Baseline, 8-weeks | 
| Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | to evaluate symptoms measured by the Alcohol Use Disorders Identification Test at 8 weeks. Based on a scale of 0 to 12, a score of 4 or greater is considered positive in males, while a score of 3 or more is positive among females. | Baseline, 8-weeks | 
| Kessler Psychiatric Distress Scale (K6) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Kessler Psychiatric Distress Scale (K6) at 8 weeks. Scores range from 0 to 24 resulting from 6 items administered on a scale of 0 to 4, with a score of 13 or greater indicative of serious psychological distress in the U.S. general population. | Baseline, 8-weeks | 
| The Patient Health Questionnaire (PHQ-9) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by The Patient Health Questionnaire (PHQ-9) at 8 weeks; On the PHQ-9, the range is 0 to 27, with higher scores indicating worse depression symptomatology. | Baseline, 8-weeks | 
| Generalized Anxiety Disorder 7-item Survey (GAD-7) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Generalized Anxiety Disorder 7-item survey (GAD-7) at 8 weeks;On the GAD-7, the range is 0 to 21, with higher scores indicating worse anxiety symptomatology. | Baseline, 8-weeks | 
| 12-item Short Form Survey (SF-12) of Physical Functioning | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by 12-item Short Form Survey (SF-12) at 8 weeks. The score mean is 50; standard deviation of 10. The physical component score (PCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better physical health. The United States population average PCS-12 is 50 points. | Baseline, 8-weeks | 
| Short Pain Scale | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Pain Scale at 8 weeks; On the pain rating, the range is 0 to 10, with higher scores indicating worse pain. | Baseline, 8-weeks | 
| Current Medications | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by a decrease in Current Medications at 8 weeks; in order to assess the potential impact of medication use concurrent with study participation, information on prescription psychotropics (including stimulants, anxiolytics, and antidepressants), anticonvulsants, antipsychotics, anticholinergic drugs, opioids, nicotine, sleeping medications, antihypertensives, and sympathomimetics/sympatholytics was collected. | Baseline, 8-weeks | 
| 12 Item Short Form Survey (SF-12) of Mental Functioning | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Mental Functioning Scale at 8 weeks. The score mean is 50; standard deviation of 10. The mental component score (MCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better mental health. The United States population average MCS-12 is 50 points. | Baseline, 8-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Depression, Distress, Alcohol Use, Pain