Back to resultsEffects of tDCS and tUS on Pain Perception in OA of the Knee
Primary Purpose
Chronic Pain, Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
transcranial ultrasound (TUS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent to participate in the study.
- Subjects between 18-85 years old.
Diagnosis of chronic osteoarthritis with pain of either the knee as self-reported.
Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail.
- Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.
- Pain resistant 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.
- Having the ability to feel pain as self-reported
Exclusion Criteria:
- Pregnancy or trying to become pregnant in the next 6 months.
- History of alcohol or drug abuse within the past 6 months as self-reported.
- Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
- Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
- Epilepsy.
- Use of carbamazepine within the past 6 months as self-reported.
- Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
- History of unexplained fainting spells as self-reported.
- Head injury resulting in more than a momentary loss of consciousness
- History of neurosurgery as self-reported.
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS + Active TUS
Sham tDCS + Sham TUS
Arm Description
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Outcomes
Primary Outcome Measures
Changes in Pain Scale
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).
Secondary Outcome Measures
Changes in Mood
The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale (VAMS).
Changes in cognition, attention, and focus
The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition, attention, and focus with the California Computerized Assessment Package (CalCap) mini.
Adverse Events
At each session, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. The scale will also be administered at the follow-ups.
Physical Examinations
Trained study staff will perform standard physical examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Single Leg Standing Balance Test
The investigators will measure how long the subject can stand on one foot in order to measure any changes in balance
Knee Proprioceptive Test
Proprioceptive acuity will be assessed by the ability to reproduce passive positioning of the leg with eyes closed.
Knee Extensor/Flexor Force Test
The investigators will measure whether there are changes in knee extension/flexion abilities.
Knee Range of Motion (ROM)
The knee range of motion (flexion/extension angle) will be recorded with an electrogoniometer and motion analysis capture system.
Step Test
Subject will be asked to stand unsupported with the feet parallel to each other and a block 5 cm directly in front of them. Subject will then be advised which leg is the stepping leg and asked to place the whole foot onto the block, then return it fully down to the floor. This procedure will be repeated as fast as possible.
Functional Reach Test
The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.
Timed Up and Go Test
The investigators will measure if there are changes in the walking speed of the subject from the beginning of the study to the end.
Changes in quality of life
The investigators will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in quality of life and physical functioning.
Neurological Examinations
Trained study staff will perform standard neurological examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Full Information
NCT ID
NCT02330315
First Posted
December 12, 2014
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02330315
Brief Title
Effects of tDCS and tUS on Pain Perception in OA of the Knee
Official Title
Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Osteoarthritis of the Knee.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Osteoarthritis
Keywords
transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS + Active TUS
Arm Type
Experimental
Arm Description
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Arm Title
Sham tDCS + Sham TUS
Arm Type
Sham Comparator
Arm Description
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. 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.
Intervention Type
Device
Intervention Name(s)
transcranial ultrasound (TUS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Pain Scale
Description
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).
Time Frame
Measured for approximately 2 months
Secondary Outcome Measure Information:
Title
Changes in Mood
Description
The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale (VAMS).
Time Frame
Measured for approximately 2 months
Title
Changes in cognition, attention, and focus
Description
The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition, attention, and focus with the California Computerized Assessment Package (CalCap) mini.
Time Frame
Measured for approximately 2 months
Title
Adverse Events
Description
At each session, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. The scale will also be administered at the follow-ups.
Time Frame
Measured for approximately 2 months
Title
Physical Examinations
Description
Trained study staff will perform standard physical examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Time Frame
Measured for approximately 2 months
Title
Single Leg Standing Balance Test
Description
The investigators will measure how long the subject can stand on one foot in order to measure any changes in balance
Time Frame
Measured for approximately 2 months
Title
Knee Proprioceptive Test
Description
Proprioceptive acuity will be assessed by the ability to reproduce passive positioning of the leg with eyes closed.
Time Frame
Measured for approximately 2 months
Title
Knee Extensor/Flexor Force Test
Description
The investigators will measure whether there are changes in knee extension/flexion abilities.
Time Frame
Measured for approximately 2 months
Title
Knee Range of Motion (ROM)
Description
The knee range of motion (flexion/extension angle) will be recorded with an electrogoniometer and motion analysis capture system.
Time Frame
Measured for approximately 2 months
Title
Step Test
Description
Subject will be asked to stand unsupported with the feet parallel to each other and a block 5 cm directly in front of them. Subject will then be advised which leg is the stepping leg and asked to place the whole foot onto the block, then return it fully down to the floor. This procedure will be repeated as fast as possible.
Time Frame
Measured for approximately 2 months
Title
Functional Reach Test
Description
The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.
Time Frame
Measured for approximately 2 months
Title
Timed Up and Go Test
Description
The investigators will measure if there are changes in the walking speed of the subject from the beginning of the study to the end.
Time Frame
Measured for approximately 2 months
Title
Changes in quality of life
Description
The investigators will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in quality of life and physical functioning.
Time Frame
Measured for approximately 2 months
Title
Neurological Examinations
Description
Trained study staff will perform standard neurological examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Time Frame
Measured for approximately 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent to participate in the study.
Subjects between 18-85 years old.
Diagnosis of chronic osteoarthritis with pain of either the knee as self-reported.
Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail.
Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.
Pain resistant 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.
Having the ability to feel pain as self-reported
Exclusion Criteria:
Pregnancy or trying to become pregnant in the next 6 months.
History of alcohol or drug abuse within the past 6 months as self-reported.
Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
Epilepsy.
Use of carbamazepine within the past 6 months as self-reported.
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
History of unexplained fainting spells as self-reported.
Head injury resulting in more than a momentary loss of consciousness
History of neurosurgery as self-reported.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wagner, PhD
Organizational Affiliation
Highland Instruments, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of tDCS and tUS on Pain Perception in OA of the Knee
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