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

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ClinicalTrials.gov Identifier: NCT03077919
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
Womack Army Medical Center
Tripler Army Medical Center
Landstuhl Regional Medical Center
Information provided by (Responsible Party):
RTI International

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.

Condition or disease Intervention/treatment Phase
PostTraumatic Stress Disorder Drug: Ropivacaine Drug: Sham treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 25, 2016
Actual Primary Completion Date : June 9, 2018
Actual Study Completion Date : June 9, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: saline




Primary Outcome Measures :
  1. Clinician Administered PTSD Score (CAPS-5) [ Time Frame: Baseline ]
    to evaluate the mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total symptom scores at baseline

  2. Clinician Administered PTSD Score (CAPS-5) [ Time Frame: 8 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in a 10 point decrease in the mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total symptom scores


Secondary Outcome Measures :
  1. PTSD Checklist (PCL-5) [ Time Frame: Baseline ]
    to evaluate symptoms measured by PTSD Checklist (PCL-5) at baseline

  2. PTSD Checklist (PCL-5) [ Time Frame: 2 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist (PCL-5) at 2 weeks

  3. PTSD Checklist (PCL-5) [ Time Frame: 4 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist (PCL-5) at 4 weeks

  4. PTSD Checklist (PCL-5) [ Time Frame: 6 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist (PCL-5) at 6 weeks

  5. PTSD Checklist (PCL-5) [ Time Frame: 8 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist (PCL-5)

  6. PTSD Checklist Civilian (PCL-C) [ Time Frame: Baseline ]
    to evaluate symptoms measured by PTSD Checklist Civilian (PCL-C) at baseline

  7. PTSD Checklist Civilian (PCL-C) [ Time Frame: 2 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist Civilian (PCL-C) at 2 weeks

  8. PTSD Checklist Civilian (PCL-C) [ Time Frame: 4 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist Civilian (PCL-C) at 4 weeks

  9. PTSD Checklist Civilian (PCL-C) [ Time Frame: 6 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist Civilian (PCL-C) at 6 weeks

  10. PTSD Checklist Civilian (PCL-C) [ Time Frame: 8 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by PTSD Checklist Civilian (PCL-C) at 8 weeks

  11. Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items [ Time Frame: Baseline ]
    to evaluate symptoms measured by Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at baseline

  12. Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items [ Time Frame: 2 weeks ]
    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 2 weeks

  13. Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items [ Time Frame: 4 weeks ]
    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 4 weeks

  14. Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items [ Time Frame: 6 weeks ]
    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 6 weeks

  15. Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items [ Time Frame: 8 weeks ]
    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

  16. Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) [ Time Frame: Baseline ]
    to evaluate symptoms measured by the Alcohol Use Disorders Identification Test at baseline

  17. Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) Improvement [ Time Frame: 4 weeks ]
    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Alcohol Use Disorders Identification Test at 4 weeks

  18. Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) [ Time Frame: 8 weeks ]
    to evaluate symptoms measured by the Alcohol Use Disorders Identification Test at 8 weeks

  19. Kessler Psychiatric Distress Scale (K6) [ Time Frame: Baseline ]
    to evaluate symptoms measured by the Kessler Psychiatric Distress Scale (K6) at baseline

  20. Kessler Psychiatric Distress Scale (K6) [ Time Frame: 2 weeks ]
    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 2 weeks

  21. Kessler Psychiatric Distress Scale (K6) [ Time Frame: 4 weeks ]
    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 4 weeks

  22. Kessler Psychiatric Distress Scale (K6) [ Time Frame: 6 weeks ]
    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 6 weeks

  23. Kessler Psychiatric Distress Scale (K6) [ Time Frame: 8 weeks ]
    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

  24. The Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline ]
    to evaluate symptoms measured by The Patient Health Questionnaire (PHQ-9) at baseline

  25. The Patient Health Questionnaire (PHQ-9) [ Time Frame: 4 weeks ]
    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 4 weeks

  26. The Patient Health Questionnaire (PHQ-9) [ Time Frame: 8 weeks ]
    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

  27. Generalized Anxiety Disorder 7-item survey (GAD-7) [ Time Frame: Baseline ]
    to evaluate symptoms measured by Generalized Anxiety Disorder 7-item survey (GAD-7) at baseline

  28. Generalized Anxiety Disorder 7-item survey (GAD-7) [ Time Frame: 4 weeks ]
    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 4 weeks

  29. Generalized Anxiety Disorder 7-item survey (GAD-7) [ Time Frame: 8 weeks ]
    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

  30. 12-item Short Form Survey (SF-12) [ Time Frame: Baseline ]
    to evaluate symptoms measured by12-item Short Form Survey (SF-12) at baseline

  31. 12-item Short Form Survey (SF-12) [ Time Frame: 4 weeks ]
    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 4 weeks

  32. 12-item Short Form Survey (SF-12) [ Time Frame: 8 weeks ]
    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

  33. Short Pain Scale [ Time Frame: Baseline ]
    to evaluate symptoms measured by the Short Pain Scale at baseline

  34. Short Pain Scale [ Time Frame: 4 weeks ]
    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 4 weeks

  35. Short Pain Scale [ Time Frame: 8 weeks ]
    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

  36. Current Medications [ Time Frame: Baseline ]
    to evaluate symptoms measured by a decrease in Current Medications at baseline

  37. Current Medications [ Time Frame: 4 weeks ]
    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 4 weeks

  38. Current Medications [ Time Frame: 8 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077919


Locations
Layout table for location information
United States, Hawaii
Tripler Army Medical Center (TAMC)
Honolulu, Hawaii, United States, 96859
United States, North Carolina
Womack Army Medical Center (WAMC)
Fort Bragg, North Carolina, United States, 28310
Germany
Landstuhl Regional Medical Center (LRMC)
Landstuhl, Germany, 66849
Sponsors and Collaborators
RTI International
Womack Army Medical Center
Tripler Army Medical Center
Landstuhl Regional Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT03077919     History of Changes
Other Study ID Numbers: SGB-201
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RTI International:
Posttraumatic Stress Disorder
Generalized Anxiety Disorder
Depression
Distress
Alcohol Use
Pain
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents