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

PostTraumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077919
• Other study ID #: SGB-201
• Status: Completed
• Phase: N/A
• Start date: May 25, 2016
• Est. completion date: June 9, 2018

Study information

• Verified date: April 2020
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 9, 2018
• Est. primary completion date: June 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• PostTraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Ropivacaine
0.5% ropivacaine
• Sham treatment
preservative-free normal saline

Locations

Country	Name	City	State
Germany	Landstuhl Regional Medical Center (LRMC)	Landstuhl
United States	Womack Army Medical Center (WAMC)	Fort Bragg	North Carolina
United States	Tripler Army Medical Center (TAMC)	Honolulu	Hawaii

Sponsors (4)

Lead Sponsor	Collaborator
RTI International	Landstuhl Regional Medical Center, Tripler Army Medical Center, Womack Army Medical Center

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

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 Tre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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