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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 |
|---|---|---|---|---|
| Sham transcranial direct current stimulation | Device | sham stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating | The WHY-MPI General Activity subscale contains 18 items summed to give a score ranging from 0 to 108 (higher scores indicate more activity [better]). | 8 weeks |
| Pain Anxiety Symptom Scale (PASS-20) Rating | The PASS-20 contains 20 items and scores could range from 0 to 100 (higher scores indicate greater pain anxiety). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Burgess, MD, PhD | Providence VA Medical Center | Principal Investigator |
| Benjamin Greenberg, MD, PhD | Providence VA Medical Center | Principal Investigator |
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Only de-identified data will be shared.
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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 stimulation |
| FG001 | Active tDCS | 10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham tDCS | 10 sessions sham transcranial direct current stimulation (tDCS) Sham transcranial direct current stimulation: sham stimulation |
| BG001 | Active tDCS | 10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes |
| 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 (WHY-MPI) General Activity Subscale Rating | The WHY-MPI General Activity subscale contains 18 items summed to give a score ranging from 0 to 108 (higher scores indicate more activity [better]). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
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 stimultion |
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small sample size (N = 21), participants were not stratified by premorbid anxiety levels, inability to guarantee optimal targeting of the left dorsal anterior cingulate cortex, inability to address laterality effects of pain perception
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Greenberg | Providence Veterans Affairs Medical Center | 4012737100 | benjamin.greenberg@va.gov |
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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 | Jun 19, 2018 | Jul 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| transcranial direct current stimulation |
| Device |
2 milliamp (mA) 20 minutes |
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Pain Anxiety Symptom Scale (PASS-20) Rating | The PASS-20 contains 20 items and scores could range from 0 to 100 (higher scores indicate greater pain anxiety). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Active tDCS | 10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |