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

NCT03077919 | Completed Results

• 1 other identifier: SGB-201
• Study Type: interventional
• Target: 113
• Locations: 2 countries
• Sites: 3

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.

Conditions

PostTraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Generalized Anxiety Disorder; Depression; Distress; Alcohol Use; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• PTSD Checklist (PCL-5)

  Baseline, 8-weeks

• PTSD Checklist Civilian (PCL-C)

  Baseline, 8-weeks

• Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items

  Baseline, 8-weeks

• Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C)

  Baseline, 8-weeks

• Kessler Psychiatric Distress Scale (K6)

  Baseline, 8-weeks

Study Arms (2)

Stellate Ganglion Block (SGB)

ACTIVE COMPARATOR

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

Sham Treatment

SHAM COMPARATOR

1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.

Drug: Sham treatment

Interventions

Ropivacaine DRUG

0.5% ropivacaine

Also known as: Naropin

Stellate Ganglion Block (SGB)

Sham treatment DRUG

preservative-free normal saline

Also known as: saline

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RTI International: lead
• Womack Army Medical Center: collaborator
• Tripler Army Medical Center: collaborator
• Landstuhl Regional Medical Center: collaborator

Study Sites (3)

Tripler Army Medical Center (TAMC)

Honolulu, Hawaii, 96859, United States

Location

Womack Army Medical Center (WAMC)

Fort Bragg, North Carolina, 28310, United States

Location

Landstuhl Regional Medical Center (LRMC)

Landstuhl, 66849, Germany

Location

Related Publications (2)

• 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.

  PMID: 31693083 RESULT

• Blakey SM, Rae Olmsted KL, Hirsch S, Asman K, Wallace D, Olmsted MG, Vandermaas-Peeler R, Karg RS, Walters BB. Differential posttraumatic stress disorder symptom cluster response to stellate ganglion block: secondary analysis of a randomized controlled trial. Transl Psychiatry. 2024 May 29;14(1):223. doi: 10.1038/s41398-024-02926-8.

  PMID: 38811568 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Depression; Alcohol Drinking; Pain

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders; Behavioral Symptoms; Behavior; Drinking Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Treating physicians unblinded; Horner syndrome noticeable; specific population re psychotropic usage, administrative evaluations, TBI history; overall PTSD symptom severity low-moderate; a number of participants still fulfil PTSD criteria at 8 weeks.

Results Point of Contact

• Title: Kristine L. Rae Olmsted, MSPH
• Organization: RTI International

krolmsted@rti.org

919-541-8035

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 13, 2017
• Study Start: May 25, 2016
• Primary Completion: June 9, 2018
• Study Completion: June 9, 2018
• Last Updated: May 13, 2020
• Results First Posted: May 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); DE (1)