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

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

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.

Study Overview

• Status: Completed
• Conditions: PostTraumatic Stress Disorder
• Intervention / Treatment: Drug: Ropivacaine; Drug: Sham treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Landstuhl, Germany, 66849
    • Landstuhl Regional Medical Center (LRMC)
• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96859
      • Tripler Army Medical Center (TAMC)
  • North Carolina
    • Fort Bragg, North Carolina, United States, 28310
      • Womack Army Medical Center (WAMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stellate Ganglion Block (SGB); 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; 0.5% ropivacaine; Other Names: Naropin
Sham Comparator: Sham Treatment; 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.	Drug: Sham treatment; preservative-free normal saline; Other Names: saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: Womack Army Medical Center; Landstuhl Regional Medical Center; Tripler Army Medical Center

Publications and helpful links

General Publications

• 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. Erratum In: JAMA Psychiatry. 2020 Jan 2;: JAMA Psychiatry. 2020 Sep 1;77(9):982.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2016
• Primary Completion (Actual): June 9, 2018
• Study Completion (Actual): June 9, 2018

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Generalized Anxiety Disorder; Pain; Posttraumatic Stress Disorder; Alcohol Use; Distress
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SGB-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No