Chronic Pain, PTSD
Conditions
Brief 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.
Detailed description
Chronic pain is one of the most prevalent health conditions among Americans, affecting about a third of the general population. In Gulf War (1990-1991) veterans, chronic pain is even more common, with a prevalence of about 50%. Indeed, the pain-related fibromyalgia diagnosis is part of Gulf War Syndrome and is highly comorbid with other common military service-related health problems such as Posttraumatic Stress Disorder (PTSD). Moreover, lack of effective, integrated, and available alternative treatments for chronic pain contributes to the opioid epidemic. PTSD is also highly prevalent in Gulf War Veterans, at about 15-25% of Operation Desert Shield and Desert Storm Veterans. Moreover, several investigators note that PTSD treatment response is poorer for Veterans who experience chronic pain and for Veterans who served in the Gulf War. 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. SA1: Integrate the home-based tDCS+PE Treatment. The investigative team is comprised of Pain, PTSD, and salivary biomarker experts who will integrate tDCS into the 12 session PE treatment protocol. H1: The 12 session PE protocol will yield itself well to tDCS component integration based on participant feedback. SA2: Test the feasibility of both the integrated intervention and key study design features, including translational research features such as biomarker assessment in a non-randomized trial with 15 Gulf War Veterans assessed at baseline and post-treatment. Feasibility of the home-based tDCS+PE intervention will be measured in terms of recruitment metrics, assessment burden, successful biomarker collection, specification of biomarker relationship to hypothesized mechanisms of change, treatment attrition, rates of missing data at each measurement time point, participant satisfaction, and ratings of treatment face validity. Post treatment key informant interviews will be conducted where suggestions for treatment enhancement and satisfaction will be systematically collected and analyzed. H2 is given in terms of Specific Pre-Defined Milestones for Success, including: 75% of Veterans experiencing chronic pain (fibromyalgia) and PTSD who enroll will complete at least 8 sessions of the integrated treatment, and both completers and dropouts will offer actionable suggestions in exit interviews for improving the delivery of the intervention. SA2) Feasibility metrics will be acceptable for recruitment rate (two per month), treatment completion of 8 sessions (75%), assessment completion (90%), and good to excellent satisfaction (95%)
Interventions
DEVICEHome-based tDCS
tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
BEHAVIORALProlonged Exposure Therapy
Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) | Week 0 | Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity. |
| Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected | Week 12 | — |
| Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples | Week 12 | — |
| Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale | Week 12 | The Charleston Psychiatric Outpatient Satisfaction Scale total score ranges from 13 to 65, with a higher score indicating higher satisfaction. |
| Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale | Week 12 | Treatment credibility will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being not credible, I did not think this treatment would help either my PTSD or Pain symptoms to 10 being completely credible, I was very sure this treatment would help both my PTSD and Pain symptoms. |
| Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale | Week 12 | Treatment acceptability will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being not acceptable, this treatment should not be offered to veterans, those in pain, or those with PTSD to 10 being completely acceptable, this treatment is perfectly suited to veterans and others with pain and PTSD symptoms. |
| Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale | Week 0 | PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from Not at all = 1 to Very much = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference. |
| Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale | Week 0 | PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from Had no pain = 1 to Very severe = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported. |
| Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions | Week 12 | — |
| Feasibility of Data Collection as Assessed by Percent of Missing Data | Week 12 | — |
| Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study | Week 0 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) | Week 0 | The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression. |
| Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | Week 0 | There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40 |
| Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Week 0 | There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale. |
| Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R) | Week 0 | Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia. |
| Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | Week 0 | Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing. |
| Salivary Biomarker Measurement | Week 0 | Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA). |
| PTSD as Assessed by the PTSD Checklist-5 (PCL-5) | Week 0 | PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home-based tDCS + Prolonged Exposure Therapy Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12). | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Home-based tDCS + Prolonged Exposure Therapy |
|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale
The Charleston Psychiatric Outpatient Satisfaction Scale total score ranges from 13 to 65, with a higher score indicating higher satisfaction.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale | 42.48 score on a scale | Standard Deviation 4.75 |
Primary
Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale
Treatment acceptability will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being not acceptable, this treatment should not be offered to veterans, those in pain, or those with PTSD to 10 being completely acceptable, this treatment is perfectly suited to veterans and others with pain and PTSD symptoms.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale | 8.9 score on a scale | Standard Deviation 0.85 |
Primary
Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale
Treatment credibility will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being not credible, I did not think this treatment would help either my PTSD or Pain symptoms to 10 being completely credible, I was very sure this treatment would help both my PTSD and Pain symptoms.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale | 8.9 score on a scale | Standard Deviation 0.85 |
Primary
Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected
Time frame: Week 12
Population: Data were not collected for this outcome measure due to COVID restrictions.
Primary
Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples
Time frame: Week 12
Population: Data were not collected for this outcome measure due to COVID restrictions.
Primary
Feasibility of Data Collection as Assessed by Percent of Missing Data
Time frame: Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Feasibility of Data Collection as Assessed by Percent of Missing Data | 0 percentage of missing data |
Primary
Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study
Time frame: Week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study | 21 Participants |
Primary
Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions | 16 Participants |
Primary
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from Had no pain = 1 to Very severe = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale | 11.19 score on a scale | Standard Deviation 1.76 |
Primary
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from Had no pain = 1 to Very severe = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale | 10.25 score on a scale | Standard Deviation 2.29 |
Primary
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from Had no pain = 1 to Very severe = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale | 10.50 score on a scale | Standard Deviation 1.86 |
Primary
Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from Not at all = 1 to Very much = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale | 28.94 score on a scale | Standard Deviation 7.32 |
Primary
Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from Not at all = 1 to Very much = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale | 25.75 score on a scale | Standard Deviation 8.69 |
Primary
Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from Not at all = 1 to Very much = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale | 31.81 score on a scale | Standard Deviation 4.05 |
Primary
PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) | 38.88 score on a scale | Standard Deviation 9.01 |
Primary
PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) | 28.19 score on a scale | Standard Deviation 14.05 |
Primary
PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) | 33.93 score on a scale | Standard Deviation 11.52 |
Secondary
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) | 17.75 score on a scale | Standard Deviation 4.77 |
Secondary
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) | 13.47 score on a scale | Standard Deviation 6.37 |
Secondary
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) | 17.31 score on a scale | Standard Deviation 4.96 |
Secondary
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia.
Time frame: Week 6
Population: Data were not collected for this outcome measure.
Secondary
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R) | 46.64 score on a scale | Standard Deviation 9.43 |
Secondary
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R) | 46.46 score on a scale | Standard Deviation 11.78 |
Secondary
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale.
Time frame: Week 6
Population: Data were not collected for this outcome measure.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Pain Interference | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Support | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Pain Severity | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Perception of Control | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Affective Distress | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Negative Responses | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Solicitous Responses | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Distracting Responses | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Household Chores | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Outdoor Work | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Activities away from Home | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Social Activities | — |
| Unknown | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | General Activity | — |
Secondary
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale.
Time frame: Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Solicitous Responses | 3.17 score on a scale | Standard Deviation 0.97 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Pain Interference | 4.09 score on a scale | Standard Deviation 1.34 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Support | 3.75 score on a scale | Standard Deviation 1.35 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Pain Severity | 3.75 score on a scale | Standard Deviation 0.94 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Perception of Control | 3.31 score on a scale | Standard Deviation 1.46 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Affective Distress | 3.50 score on a scale | Standard Deviation 0.73 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Negative Responses | 2.81 score on a scale | Standard Deviation 1.27 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Distracting Responses | 3.25 score on a scale | Standard Deviation 1.69 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Household Chores | 2.68 score on a scale | Standard Deviation 1.44 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Outdoor Work | 2.53 score on a scale | Standard Deviation 1.52 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Activities away from Home | 2.47 score on a scale | Standard Deviation 1.52 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Social Activities | 2.47 score on a scale | Standard Deviation 1.36 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | General Activity | 2.54 score on a scale | Standard Deviation 1.3 |
Secondary
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale.
Time frame: Week 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Pain Interference | 4.73 score on a scale | Standard Deviation 0.8 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Support | 4.21 score on a scale | Standard Deviation 1.7 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Pain Severity | 4.54 score on a scale | Standard Deviation 0.83 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Perception of Control | 3.31 score on a scale | Standard Deviation 1.16 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Affective Distress | 4.21 score on a scale | Standard Deviation 0.91 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Negative Responses | 2.50 score on a scale | Standard Deviation 1.34 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Solicitous Responses | 2.42 score on a scale | Standard Deviation 1.36 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Distracting Responses | 2.38 score on a scale | Standard Deviation 1.72 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Household Chores | 3.10 score on a scale | Standard Deviation 1.65 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Outdoor Work | 2.03 score on a scale | Standard Deviation 1.58 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Activities away from Home | 2.00 score on a scale | Standard Deviation 0.9 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | Social Activities | 2.13 score on a scale | Standard Deviation 0.99 |
| Home-based tDCS + Prolonged Exposure Therapy | Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) | General Activity | 2.34 score on a scale | Standard Deviation 0.93 |
Secondary
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Time frame: Week 6
Population: Data were not collected for this outcome measure.
Secondary
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 33.42 score on a scale | Standard Deviation 11.27 |
Secondary
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | 29.42 score on a scale | Standard Deviation 15.03 |
Secondary
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | PTSD as Assessed by the PTSD Checklist-5 (PCL-5) | 38.33 score on a scale | Standard Deviation 20.61 |
Secondary
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | PTSD as Assessed by the PTSD Checklist-5 (PCL-5) | 51.23 score on a scale | Standard Deviation 14.2 |
Secondary
PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | PTSD as Assessed by the PTSD Checklist-5 (PCL-5) | 57.69 score on a scale | Standard Deviation 12.67 |
Secondary
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40
Time frame: Week 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | environmental health domain | 25.18 score on a scale | Standard Deviation 5.47 |
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | physical health domain | 19.25 score on a scale | Standard Deviation 2.67 |
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | psychological health domain | 15.33 score on a scale | Standard Deviation 4.29 |
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | social relationships domain | 6.50 score on a scale | Standard Deviation 2.91 |
Secondary
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40
Time frame: Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | physical health domain | 20.50 score on a scale | Standard Deviation 3.03 |
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | psychological health domain | 16.83 score on a scale | Standard Deviation 3.16 |
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | social relationships domain | 8.00 score on a scale | Standard Deviation 3.38 |
| Home-based tDCS + Prolonged Exposure Therapy | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | environmental health domain | 27.64 score on a scale | Standard Deviation 5.45 |
Secondary
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40
Time frame: Week 6
Population: Data were not collected for this outcome measure.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | physical health domain | — |
| Unknown | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | psychological health domain | — |
| Unknown | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | social relationships domain | — |
| Unknown | Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) | environmental health domain | — |
Secondary
Salivary Biomarker Measurement
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Time frame: Week 6
Population: Data were not collected for this outcome measure due to COVID restrictions.
Secondary
Salivary Biomarker Measurement
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Time frame: Week 0
Population: Data were not collected for this outcome measure due to COVID restrictions.
Secondary
Salivary Biomarker Measurement
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Time frame: Week 12
Population: Data were not collected for this outcome measure due to COVID restrictions.