Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Highland Instruments, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Electrical Stim/Active Ultrasound | Experimental | Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. |
|
| Sham Electrical Stim/Sham Ultrasound | Sham Comparator | Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active low-intensity transcranial electrical stimulation/active transcranial ultrasound | Device | Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Scale as Measured by VAS | Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Dose of Acetaminophen Equivalent | Analgesic use (average daily dose of acetaminophen equivalent) | 8 weeks |
| Changes in Pain Scale as Measured by VAS | Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain. Since we are using a difference, smaller values (negative) represent a better outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Network Research Institute | Charlestown | Massachusetts | 02129 | United States |
64 subjects were enrolled and randomized
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Electrical Stim/Active Ultrasound | Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 29, 2019 |
Not provided
tDCS and tUS
Not provided
Not provided
Not provided
|
| Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound | Device | Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes. |
|
| Baseline and 4 weeks post-stimulation |
| Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline | This measures the endogenous pain modulatory pathway. This study will evaluate DNIC in pain patients using pressure as the test stimulus, and cold water as the conditioning stimulus. DNIC will be induced approximately 1-min later by having subjects immerse their hand into a water bath maintained at 10-12˚C for approximately 1 min. Parallel to the last 30s of DNIC conditioning (cold water immersion), the pressure test stimulus will be reapplied. DNIC response will be calculated as the difference between the average of pain ratings from the test stimulus minus the average of pain ratings during the conditioned stimulus. Larger percentage change means a better outcome. | Baseline and 8 weeks |
| Percentage Change From Baseline in the Single Leg Standing Balance Test | We will record the time (seconds) for which a subject is able to stand unsupported on one foot while looking straight ahead with hands on hips. Larger percentage change means a better outcome. | Baseline and 8 weeks |
| Percentage Change From Baseline in the Step Test | The subject was asked to stand unsupported with their feet parallel to each other in front of a step. We assessed the number of times the participant could place their foot up onto the step and return it to the floor over a 15-sec interval. Larger percentage change means a better outcome. | Baseline and 8 weeks |
| Percentage Change in Functional Reach Test From Baseline | Subject will be instructed to stand next to, but not touch the wall, and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. Smoothness of wrist movement is assessed as the subject was asked to outstretch their arm in a maximal forward reach, while maintaining a fixed base of support. Smoothness is dimensionless and is calculated as mean speed divided by peak speed. Larger percentage change means a better outcome. | Baseline and 8 weeks |
| FG001 | Sham Electrical Stim/Sham Ultrasound | Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes. |
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline participants for randomized subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Electrical Stim/Active Ultrasound | Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes. |
| BG001 | Sham Electrical Stim/Sham Ultrasound | Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Changes in Pain Scale as Measured by VAS | Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome | Posted | Mean | Standard Error | units on a scale | Baseline and 8 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Average Daily Dose of Acetaminophen Equivalent | Analgesic use (average daily dose of acetaminophen equivalent) | Posted | Mean | Standard Error | Acetaminophen equivalent in mg | 8 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Changes in Pain Scale as Measured by VAS | Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain. Since we are using a difference, smaller values (negative) represent a better outcome. | Posted | Mean | Standard Error | units on a scale | Baseline and 4 weeks post-stimulation |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline | This measures the endogenous pain modulatory pathway. This study will evaluate DNIC in pain patients using pressure as the test stimulus, and cold water as the conditioning stimulus. DNIC will be induced approximately 1-min later by having subjects immerse their hand into a water bath maintained at 10-12˚C for approximately 1 min. Parallel to the last 30s of DNIC conditioning (cold water immersion), the pressure test stimulus will be reapplied. DNIC response will be calculated as the difference between the average of pain ratings from the test stimulus minus the average of pain ratings during the conditioned stimulus. Larger percentage change means a better outcome. | Posted | Mean | Standard Error | Percentage change from baseline | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in the Single Leg Standing Balance Test | We will record the time (seconds) for which a subject is able to stand unsupported on one foot while looking straight ahead with hands on hips. Larger percentage change means a better outcome. | Posted | Mean | Standard Error | Percentage change from baseline | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in the Step Test | The subject was asked to stand unsupported with their feet parallel to each other in front of a step. We assessed the number of times the participant could place their foot up onto the step and return it to the floor over a 15-sec interval. Larger percentage change means a better outcome. | Posted | Mean | Standard Error | Percentage change from baseline | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Functional Reach Test From Baseline | Subject will be instructed to stand next to, but not touch the wall, and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. Smoothness of wrist movement is assessed as the subject was asked to outstretch their arm in a maximal forward reach, while maintaining a fixed base of support. Smoothness is dimensionless and is calculated as mean speed divided by peak speed. Larger percentage change means a better outcome. | Posted | Mean | Standard Error | Percentage change from baseline | Baseline and 8 weeks |
|
2 months
Adverse effects were collected with a questionnaire for adverse effects
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Electrical Stim/Active Ultrasound | Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes. | 0 | 30 | 0 | 30 | 23 | 30 |
| EG001 | Sham Electrical Stim/Sham Ultrasound | Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes. | 0 | 34 | 0 | 34 | 29 | 34 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling | Nervous system disorders | Systematic Assessment | Sensation of tingling near the stimulation site. |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felipe Fregni | Spaulding Rehabilitation Hospital | 6179526158 | Fregni.felipe@mgh.harvard.edu |
| Jul 13, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|