Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03077919
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2017-03-01
Brief Title:
Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Effectiveness
Sponsor:
RTI International
Organization:
RTI International
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studyThe acceptability study is described in a separate entry
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 05 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 MINI-Plus Suicidality Items at 0 2 4 6 and 8 weeks they also will complete the MINI-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-CAUDIT 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
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 MINI-Plus Suicidality Items at 0 2 4 6 and 8 weeks they also will complete the MINI-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-CAUDIT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None