N/A
N=21
Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
Chronic Pain · PTSD
Bottom Line
View on ClinicalTrials.gov: NCT04236284 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study — 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-based tDCS (Device); Prolonged Exposure Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study |
21 | — |
| PRIMARY Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected |
— | — |
| PRIMARY Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples |
— | — |
| PRIMARY Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions |
16 | — |
| PRIMARY Feasibility of Data Collection as Assessed by Percent of Missing Data |
— | — |
| PRIMARY Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale |
42.48 | — |
| PRIMARY Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale |
8.9 | — |
| PRIMARY Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale |
8.9 | — |
| PRIMARY Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale |
25.75 | — |
| PRIMARY Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale |
25.75 | — |
| PRIMARY Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale |
25.75 | — |
| PRIMARY Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale |
10.25 | — |
| PRIMARY Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale |
10.25 | — |
| PRIMARY Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale |
10.25 | — |
| PRIMARY PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) |
28.19 | — |
| PRIMARY PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) |
28.19 | — |
| PRIMARY PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) |
28.19 | — |
| SECONDARY PTSD as Assessed by the PTSD Checklist-5 (PCL-5) |
38.33 | — |
| SECONDARY PTSD as Assessed by the PTSD Checklist-5 (PCL-5) |
38.33 | — |
| SECONDARY PTSD as Assessed by the PTSD Checklist-5 (PCL-5) |
38.33 | — |
| SECONDARY Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) |
13.47 | — |
| SECONDARY Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) |
13.47 | — |
| SECONDARY Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) |
13.47 | — |
| SECONDARY Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) |
20.50; 16.83; 8.00; 27.64 | — |
| SECONDARY Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) |
20.50; 16.83; 8.00; 27.64 | — |
| SECONDARY Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) |
20.50; 16.83; 8.00; 27.64 | — |
| SECONDARY Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) |
4.09; 3.75; 3.75; 3.31; 3.50; 2.81 | — |
| SECONDARY Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) |
4.09; 3.75; 3.75; 3.31; 3.50; 2.81 | — |
| SECONDARY Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) |
4.09; 3.75; 3.75; 3.31; 3.50; 2.81 | — |
| SECONDARY Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R) |
46.46 | — |
| SECONDARY Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R) |
46.46 | — |
| SECONDARY Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R) |
46.46 | — |
| SECONDARY Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) |
29.42 | — |
| SECONDARY Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) |
29.42 | — |
| SECONDARY Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) |
29.42 | — |
| SECONDARY Salivary Biomarker Measurement |
— | — |
| SECONDARY Salivary Biomarker Measurement |
— | — |
| SECONDARY Salivary Biomarker Measurement |
— | — |
Summary
Gulf War Veterans (a DoD/VA defined service era corresponding to the first Gulf War under operations Desert Storm and Desert Shield 1990-1991), especially those who present with Post-Traumatic Stress Disorder (PTSD), are particularly likely to experience chronic pain. Veterans with co-morbid chronic pain and PTSD utilize healthcare services at a higher rate than those with pain or PTSD alone. Unfortunately, there are no integrated treatments for Pain and PTSD. Moreover, non-pharmacological treatments for pain such as Cognitive Behavioral Therapy are useful in only about 50% of cases. Transcranial direct current stimulation (tDCS) may be an effective treatment for pain, and has been recently used to ameliorate PTSD symptoms. Prolonged Exposure Therapy (PE) is highly effective in treating PTSD symptoms. Therefore, we propose to (a) integrate & (b) gather feasibility data for home-based tDCS + PE for Pain and PTSD with 15 Gulf War Veterans.
The Overall Aim of the present proposal is to integrate, refine and investigate the feasibility (e.g., pilot testing, recruitment, attrition, assessment) of tDCS for treating chronic pain with a best practices evidence-based treatment for PTSD (i.e., Prolonged Exposure: PE) in 15 Gulf War veterans, a group for which both pain (fibromyalgia) and PTSD are particularly problematic.
Eligibility Criteria
Inclusion Criteria
- Presence of chronic non-cancer pain and pain interference, defined as scoring 1 standard deviation above PROMIS normative data on both the 3-item PROMIS Pain Intensity 3a scal and the 8-item PROMIS Pain 8a Interference scale. Symptoms will be required to be of six-month duration or longer
- Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale.
Exclusion Criteria
- Having a household member who is already enrolled in the study
- Active psychosis or dementia at screening
- Suicidal ideation with clear intent
- Current substance dependence
- current opioid medication for pain.
Data sourced from ClinicalTrials.gov (NCT04236284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.