Chronic Low Back Pain
Conditions
Brief summary
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.
Interventions
DEVICEtranscranial direct current stimulation
active stimulation: 2 milliamp (mA), 20 mins
DEVICEsham transcranial direct current stimulation
sham stimulation
Sponsors
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Low Back Pain ≥ 6 months duration in the lumbar region, present more than half the days of the month, and on average be at a moderate level of severity in the last month * At least one trial of physician recommended medication (e.g. acetaminophen, NSAIDS, skeletal muscle relaxants) * Pre-existing opioid and non-opioid pain medication must be non-existent or stable (medications have not changed for one month) * Be able to understand, read and write English * If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method)
Exclusion criteria
* Lifetime Diagnostic and Statistical Manual (DSM) IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition * Current DSM-IV diagnosis of substance dependence for alcohol, sedative/hypnotic drugs, stimulants, cocaine * Current cancer, infection, or inflammatory arthritis * Broken skin or other lesions in the area of the electrodes * Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation * Presence of metal in the cranial cavity * Holes in the skull made by trauma or surgery * Pacemakers, medication pumps, and other implanted electronic hardware * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating | 8 weeks total | 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). |
| Pain Anxiety Symptom Scale Rating | 8 weeks total | 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. |
Participant flow
Pre-assignment details
Of the 30 participants that were consented, 9 participants were ineligible, withdrew, or were lost to contact before commencing tDCS.
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS 10 sessions sham transcranial direct current stimulation (tDCS)
sham transcranial direct current stimulation: active : 2 mA, 20 mins | 10 |
| Sham tDCS 10 sessions sham transcranial direct current stimulation (tDCS)
sham transcranial direct current stimulation: sham | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 8.8 | 60.7 years STANDARD_DEVIATION 11.8 | 63.1 years STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
| Years of Education | 14.0 years STANDARD_DEVIATION 2.6 | 14.7 years STANDARD_DEVIATION 2.6 | 14.4 years STANDARD_DEVIATION 2.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
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.
Time frame: 8 weeks total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham tDCS | Pain Anxiety Symptom Scale Rating | 26.4 score on a scale | Standard Deviation 22 |
| Active tDCS | Pain Anxiety Symptom Scale Rating | 26.3 score on a scale | Standard Deviation 23.6 |
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).
Time frame: 8 weeks total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham tDCS | West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating | 35.3 score on a scale | Standard Deviation 17.7 |
| Active tDCS | West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating | 48.4 score on a scale | Standard Deviation 21.2 |