Chronic Low Back Pain, Chronic Pain
Conditions
Keywords
transcranial Direct Current Stimulation, Transcranial Ultrasound, non-invasive brain stimulation
Brief summary
The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
Interventions
DEVICEtranscranial Direct Current Stimulation (tDCS)
Subjects will receive 20 minutes of either active or sham tDCS at an intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Sponsors
Highland Instruments, Inc.
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Phase II
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Able to provide informed consent to participate in the study 2. Subjects between 18 to 85 years old 3. Subjects having non-specific chronic low back pain with existing pain for at least 3 months and having pain on at least half the days in the past 6 months with an average of at least 3 on a 0-10 visual analog scale (VAS) scale 4. Pain resistant (partial or no response) to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine. 5. Must have the ability to feel sensation by Von-Frey fiber on the forearm
Exclusion criteria
1. Subject is pregnant 2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices 3. History of alcohol or drug abuse within the past 6 months as self reported 4. Use of carbamazepine within the past 6 months as self reported 5. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory) 6. History of neurological disorders as self reported 7. History of unexplained fainting spells as self reported 8. History of severe head injury resulting in more than a momentary loss of consciousness as self reported 9. History of neurosurgery as self reported 10. Unstable pain 11. Large placebo responder 12. Low adherence during the run-in period 13. Low baseline pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mechanical Temporal Summation (Hand) | Baseline and 3.5 months | Changes in Mechanical Temporal Summation (TS) from hand will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in reducing pain of subjects with non-specific chronic low back pain. |
| Changes in Conditional Pain Modulation (Hand) | Baseline and 3.5 months | Changes in Conditional Pain Modulation (CPM) will be measured in the hand in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in increasing the pain pressure threshold in subjects with non-specific chronic low back pain. |
| Changes in Pain | Baseline and 3.5 months | Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to measure any changes in pain levels when subjects come in for sessions. |
Countries
United States
Participant flow
Pre-assignment details
40 subjects were enrolled and randomized
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS + Active TUS - Phase II Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes. | 20 |
| Sham tDCS + Sham TUS - Phase II Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Active tDCS + Active TUS - Phase II | Total | Sham tDCS + Sham TUS - Phase II |
|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 18.6 | 48.2 years STANDARD_DEVIATION 17.1 | 47.3 years STANDARD_DEVIATION 15.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 31 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 26 Participants | 13 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 20 Participants | 14 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 15 / 20 | 13 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Changes in Conditional Pain Modulation (Hand)
Changes in Conditional Pain Modulation (CPM) will be measured in the hand in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in increasing the pain pressure threshold in subjects with non-specific chronic low back pain.
Time frame: Baseline and 3.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS + Active TUS | Changes in Conditional Pain Modulation (Hand) | 94 CPM percentage changes | Standard Error 22 |
| Sham tDCS + Sham TUS | Changes in Conditional Pain Modulation (Hand) | -4 CPM percentage changes | Standard Error 19 |
Primary
Changes in Mechanical Temporal Summation (Hand)
Changes in Mechanical Temporal Summation (TS) from hand will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in reducing pain of subjects with non-specific chronic low back pain.
Time frame: Baseline and 3.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS + Active TUS | Changes in Mechanical Temporal Summation (Hand) | 15 TSPS percentage change | Standard Error 8 |
| Sham tDCS + Sham TUS | Changes in Mechanical Temporal Summation (Hand) | -4 TSPS percentage change | Standard Error 9 |
Primary
Changes in Pain
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to measure any changes in pain levels when subjects come in for sessions.
Time frame: Baseline and 3.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS + Active TUS | Changes in Pain | 45 percentage changes | Standard Error 2.4 |
| Sham tDCS + Sham TUS | Changes in Pain | 24 percentage changes | Standard Error 2 |