PostTraumatic Stress Disorder
Conditions
Keywords
Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Depression, Distress, Alcohol Use, Pain
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.
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.
Interventions
DRUGRopivacaine
0.5% ropivacaine
DRUGSham treatment
preservative-free normal saline
Sponsors
Womack Army Medical Center
Tripler Army Medical Center
Landstuhl Regional Medical Center
RTI International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Score (CAPS-5) TSSS | Baseline, 8-weeks | ≥ 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist Civilian (PCL-C) | Baseline, 8-weeks | 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 |
| Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | Baseline, 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. 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. |
| Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | Baseline, 8-weeks | 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. |
| Kessler Psychiatric Distress Scale (K6) | Baseline, 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. 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. |
| The Patient Health Questionnaire (PHQ-9) | Baseline, 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; On the PHQ-9, the range is 0 to 27, with higher scores indicating worse depression symptomatology. |
| PTSD Checklist (PCL-5) | Baseline, 8-weeks | 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. |
| 12-item Short Form Survey (SF-12) of Physical Functioning | Baseline, 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. 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. |
| Short Pain Scale | Baseline, 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; On the pain rating, the range is 0 to 10, with higher scores indicating worse pain. |
| Current Medications | Baseline, 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; 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. |
| 12 Item Short Form Survey (SF-12) of Mental Functioning | Baseline, 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 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. |
| Generalized Anxiety Disorder 7-item Survey (GAD-7) | Baseline, 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;On the GAD-7, the range is 0 to 21, with higher scores indicating worse anxiety symptomatology. |
Countries
Germany, United States
Participant flow
Recruitment details
123 participants screened eligible and completed the baseline CAPS-5
Pre-assignment details
113 participants were randomized to treatment/sham and underwent the study procedure at Week 0 and Week 2.
Participants by arm
| Arm | Count |
|---|---|
| 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).
Ropivacaine: 0.5% ropivacaine | 74 |
| Sham Treatment 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline | 39 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
Baseline characteristics
| Characteristic | Stellate Ganglion Block (SGB) | Sham Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 39 Participants | 113 Participants |
| Marital Status Married | 67 Participants | 33 Participants | 100 Participants |
| Marital Status Unmarried | 7 Participants | 6 Participants | 13 Participants |
| Met CAPS-5 Criteria for PTSD | 60 Participants | 31 Participants | 91 Participants |
| Military Rank Commissioned Officer | 11 Participants | 3 Participants | 14 Participants |
| Military Rank Junior Enlisted | 3 Participants | 3 Participants | 6 Participants |
| Military Rank Non-commissioned Officer | 27 Participants | 11 Participants | 38 Participants |
| Military Rank Senior Enlisted | 28 Participants | 19 Participants | 47 Participants |
| Military Rank Warrant Officer | 5 Participants | 3 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 64 Participants | 36 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 39 |
| other Total, other adverse events | 5 / 74 | 1 / 39 |
| serious Total, serious adverse events | 0 / 74 | 0 / 39 |
Outcome results
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).
Time frame: Baseline, 8-weeks
Population: Multiple imputation performed for missing data; Mean change - Adjusted for site and baseline CAPS TSSS; adjusted mean reduction in TSSS from baseline to week 8 by treatment group from per-protocol analysis and secondary analysis among those who fulfilled CAPS 5 diagnostic criteria for PTSD at baseline were consistent with those from ITT analyses
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | Clinician Administered PTSD Score (CAPS-5) TSSS | Baseline | 37.61 score on a scale | Standard Deviation 11.13 |
| Stellate Ganglion Block (SGB) | Clinician Administered PTSD Score (CAPS-5) TSSS | 8-week follow-up | 25.67 score on a scale | Standard Deviation 14.13 |
| Sham Treatment | Clinician Administered PTSD Score (CAPS-5) TSSS | Baseline | 39.82 score on a scale | Standard Deviation 14.23 |
| Sham Treatment | Clinician Administered PTSD Score (CAPS-5) TSSS | 8-week follow-up | 33.68 score on a scale | Standard Deviation 15.6 |
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.
Time frame: Baseline, 8-weeks
Population: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | 12 Item Short Form Survey (SF-12) of Mental Functioning | Baseline | 41.24 score on a scale | Standard Deviation 11.32 |
| Stellate Ganglion Block (SGB) | 12 Item Short Form Survey (SF-12) of Mental Functioning | 8-week follow-up | 42.83 score on a scale | Standard Deviation 10.22 |
| Sham Treatment | 12 Item Short Form Survey (SF-12) of Mental Functioning | Baseline | 40.16 score on a scale | Standard Deviation 9.84 |
| Sham Treatment | 12 Item Short Form Survey (SF-12) of Mental Functioning | 8-week follow-up | 40.17 score on a scale | Standard Deviation 9.5 |
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.
Time frame: Baseline, 8-weeks
Population: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | 12-item Short Form Survey (SF-12) of Physical Functioning | Baseline | 41.04 score on a scale | Standard Deviation 8.16 |
| Stellate Ganglion Block (SGB) | 12-item Short Form Survey (SF-12) of Physical Functioning | 8-week follow-up | 43.43 score on a scale | Standard Deviation 8.33 |
| Sham Treatment | 12-item Short Form Survey (SF-12) of Physical Functioning | Baseline | 42.01 score on a scale | Standard Deviation 7.87 |
| Sham Treatment | 12-item Short Form Survey (SF-12) of Physical Functioning | 8-week follow-up | 41.28 score on a scale | Standard Deviation 8.18 |
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.
Time frame: Baseline, 8-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | Baseline | 2.74 score on a scale | Standard Deviation 2.64 |
| Stellate Ganglion Block (SGB) | Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | 8-week follow-up | 2.72 score on a scale | Standard Deviation 2.71 |
| Sham Treatment | Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | Baseline | 3.18 score on a scale | Standard Deviation 4.26 |
| Sham Treatment | Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | 8-week follow-up | 2.62 score on a scale | Standard Deviation 3.8 |
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.
Time frame: Baseline, 8-weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stellate Ganglion Block (SGB) | Current Medications | Baseline | 1 Medications |
| Stellate Ganglion Block (SGB) | Current Medications | 8-week follow-up | 1 Medications |
| Sham Treatment | Current Medications | Baseline | 2 Medications |
| Sham Treatment | Current Medications | 8-week follow-up | 1 Medications |
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.
Time frame: Baseline, 8-weeks
Population: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | Generalized Anxiety Disorder 7-item Survey (GAD-7) | Baseline | 12.39 score on a scale | Standard Deviation 5.35 |
| Stellate Ganglion Block (SGB) | Generalized Anxiety Disorder 7-item Survey (GAD-7) | 8-week follow-up | 8.11 score on a scale | Standard Deviation 6.02 |
| Sham Treatment | Generalized Anxiety Disorder 7-item Survey (GAD-7) | Baseline | 12.49 score on a scale | Standard Deviation 5.5 |
| Sham Treatment | Generalized Anxiety Disorder 7-item Survey (GAD-7) | 8-week follow-up | 11.19 score on a scale | Standard Deviation 6.38 |
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.
Time frame: Baseline, 8-weeks
Population: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | Kessler Psychiatric Distress Scale (K6) | Baseline | 10.08 score on a scale | Standard Deviation 5.55 |
| Stellate Ganglion Block (SGB) | Kessler Psychiatric Distress Scale (K6) | 8-week follow-up | 7.80 score on a scale | Standard Deviation 6.41 |
| Sham Treatment | Kessler Psychiatric Distress Scale (K6) | Baseline | 10.33 score on a scale | Standard Deviation 6.01 |
| Sham Treatment | Kessler Psychiatric Distress Scale (K6) | 8-week follow-up | 10.00 score on a scale | Standard Deviation 6.25 |
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.
Time frame: Baseline, 8-weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stellate Ganglion Block (SGB) | Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | Baseline | 0 number of events |
| Stellate Ganglion Block (SGB) | Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | 8-week follow-up | 0 number of events |
| Sham Treatment | Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | Baseline | 0 number of events |
| Sham Treatment | Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | 8-week follow-up | 0 number of events |
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
Time frame: Baseline, 8-weeks
Population: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | PTSD Checklist Civilian (PCL-C) | Baseline | 53.30 score on a scale | Standard Deviation 13.64 |
| Stellate Ganglion Block (SGB) | PTSD Checklist Civilian (PCL-C) | 8-week follow-up | 42.41 score on a scale | Standard Deviation 17.47 |
| Sham Treatment | PTSD Checklist Civilian (PCL-C) | Baseline | 54.95 score on a scale | Standard Deviation 15.67 |
| Sham Treatment | PTSD Checklist Civilian (PCL-C) | 8-week follow-up | 50.65 score on a scale | Standard Deviation 17.04 |
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.
Time frame: Baseline, 8-weeks
Population: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | PTSD Checklist (PCL-5) | Baseline | 41.54 score on a scale | Standard Deviation 14.03 |
| Stellate Ganglion Block (SGB) | PTSD Checklist (PCL-5) | 8-week follow-up | 29.49 score on a scale | Standard Deviation 19.29 |
| Sham Treatment | PTSD Checklist (PCL-5) | Baseline | 43.23 score on a scale | Standard Deviation 18.13 |
| Sham Treatment | PTSD Checklist (PCL-5) | 8-week follow-up | 38.11 score on a scale | Standard Deviation 18.23 |
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.
Time frame: Baseline, 8-weeks
Population: \[\*\] Analysis Population Description Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | Short Pain Scale | Baseline | 4.61 score on a scale | Standard Deviation 2.4 |
| Stellate Ganglion Block (SGB) | Short Pain Scale | 8-week follow-up | 4.10 score on a scale | Standard Deviation 2.51 |
| Sham Treatment | Short Pain Scale | Baseline | 4.95 score on a scale | Standard Deviation 2.21 |
| Sham Treatment | Short Pain Scale | 8-week follow-up | 4.86 score on a scale | Standard Deviation 2.3 |
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.
Time frame: Baseline, 8-weeks
Population: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | The Patient Health Questionnaire (PHQ-9) | 8-week follow-up | 8.68 score on a scale | Standard Deviation 6.02 |
| Stellate Ganglion Block (SGB) | The Patient Health Questionnaire (PHQ-9) | Baseline | 12.57 score on a scale | Standard Deviation 6.05 |
| Sham Treatment | The Patient Health Questionnaire (PHQ-9) | Baseline | 12.69 score on a scale | Standard Deviation 6.61 |
| Sham Treatment | The Patient Health Questionnaire (PHQ-9) | 8-week follow-up | 11.76 score on a scale | Standard Deviation 6.25 |