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The goal of this study is to investigate the role of central neural pathways in mediating chronic pain. The aim of the study is to test the effect of stimulating brain regions that are part of a network underlying central pain processing using a non-invasive brain stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have used tDCS to target both sensory related cortical areas and those important for higher-order representations of pain. This study will target brain regions important for the behavioral response to the chronic sensation of pain. The hypothesis is that stimulation of these brain regions can modulate not only the affective component of pain, but ultimately also improve functioning and quality of life. This hypothesis will be tested by treating study participants eighteen and older with chronic low back pain (CLBP) of greater than six months using tDCS. To be part of this study, participants must meet all the inclusion and exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham tDCS | Sham Comparator | 10 sessions sham transcranial direct current stimulation (tDCS) |
|
| active tDCS | Experimental | 10 sessions active transcranial direct current stimulation (tDCS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | active stimulation: 2 milliamp (mA), 20 mins |
|
| Measure | Description | Time Frame |
|---|---|---|
| West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating | Subscale C of the West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) is a validated measure of chronic pain's effects on functioning. Ranging from 0-108, higher scores indicate more activity (better outcome). | 8 weeks total |
| Pain Anxiety Symptom Scale Rating | The Pain Anxiety Symptom Scale (PASS-20) is a validated measure of pain-related avoidance and fear. Total score ranges 0-100. Higher scores indicate greater pain anxiety. | 8 weeks total |
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Inclusion Criteria:
Exclusion Criteria:
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Of the 30 participants that were consented, 9 participants were ineligible, withdrew, or were lost to contact before commencing tDCS.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham tDCS | 10 sessions sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation: sham |
| FG001 | Active tDCS | 10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: active stimulation: 2 milliamp (mA), 20 mins |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The data collected from the 21 participants who completed tDCS treatment (either active or sham) is included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | 10 sessions sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation: active : 2 mA, 20 mins |
| BG001 | Sham tDCS | 10 sessions sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation: sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating | Subscale C of the West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) is a validated measure of chronic pain's effects on functioning. Ranging from 0-108, higher scores indicate more activity (better outcome). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks total |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham tDCS | 10 sessions sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation: sham |
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small sample (N=21), participants not stratified by premorbid anxiety levels, inability to guarantee optimal targeting of left dorsal anterior cingulate cortex (dACC) in all participants, inability to address laterality effects of pain perception
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Greenberg | Butler Hospital | (401) 455-6200 | bgreenberg@butler.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2015 | Jul 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| sham transcranial direct current stimulation | Device | sham stimulation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
|
|
| Primary | Pain Anxiety Symptom Scale Rating | The Pain Anxiety Symptom Scale (PASS-20) is a validated measure of pain-related avoidance and fear. Total score ranges 0-100. Higher scores indicate greater pain anxiety. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks total |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Active tDCS | 10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: active stimulation: 2 milliamp (mA), 20 mins | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |