Chronic Pain, Osteoarthritis
Conditions
Keywords
transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation
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.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
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.
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)
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 18-85 years old. 3. 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. 4. Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average. 5. 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. 6. Having the ability to feel pain as self-reported
Exclusion criteria
1. Pregnancy or trying to become pregnant in the next 6 months. 2. History of alcohol or drug abuse within the past 6 months as self-reported. 3. Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices. 4. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease). 5. Epilepsy. 6. Use of carbamazepine within the past 6 months as self-reported. 7. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory) 8. History of unexplained fainting spells as self-reported. 9. Head injury resulting in more than a momentary loss of consciousness 10. History of neurosurgery as self-reported.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Scale | Measured for approximately 2 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in cognition, attention, and focus | Measured for approximately 2 months | 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 | Measured for approximately 2 months | 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 | Measured for approximately 2 months | 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 | Measured for approximately 2 months | The investigators will measure how long the subject can stand on one foot in order to measure any changes in balance |
| Knee Proprioceptive Test | Measured for approximately 2 months | Proprioceptive acuity will be assessed by the ability to reproduce passive positioning of the leg with eyes closed. |
| Knee Extensor/Flexor Force Test | Measured for approximately 2 months | The investigators will measure whether there are changes in knee extension/flexion abilities. |
| Changes in Mood | Measured for approximately 2 months | The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale (VAMS). |
| Step Test | Measured for approximately 2 months | 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 | Measured for approximately 2 months | The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study. |
| Timed Up and Go Test | Measured for approximately 2 months | 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 | Measured for approximately 2 months | 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 | Measured for approximately 2 months | 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. |
| Knee Range of Motion (ROM) | Measured for approximately 2 months | The knee range of motion (flexion/extension angle) will be recorded with an electrogoniometer and motion analysis capture system. |
Countries
United States
Outcome results
None listed