CLINICAL TRIAL

active low-intensity transcranial electrical stimulation/active transcranial ultrasound for Arthrosis

Waitlist Available · 18+ · All Sexes · Charlestown, MA

This study is evaluating whether a combination of tDCS and TUS can reduce pain in people with osteoarthritis of the knee.

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About the trial for Arthrosis

Eligible Conditions
Chronic Pain · Osteoarthritis

Treatment Groups

This trial involves 2 different treatments. Active Low-intensity Transcranial Electrical Stimulation/active Transcranial Ultrasound is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
active low-intensity transcranial electrical stimulation/active transcranial ultrasound
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The study includes participants who are 18 to 85 years old. show original
The person experiences knee pain on a regular basis that is usually at least a 3 on a 0-10 scale. show original
The patient has pain that is resistant to common analgesics such as Tylenol, Aspirin, Ibuprofen, and Codeine show original
The participants reported an average pain score of at least three on a zero to ten visual analogue scale over the week prior to the first stimulation session. show original
Feeling pain as self-reported. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 8 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 8 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether active low-intensity transcranial electrical stimulation/active transcranial ultrasound will improve 6 secondary outcomes in patients with Arthrosis. Measurement will happen over the course of Baseline and 4 weeks post-stimulation.

Changes in Pain Scale as Measured by VAS
BASELINE AND 4 WEEKS POST-STIMULATION
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.
Percentage Change From Baseline in the Single Leg Standing Balance Test
BASELINE AND 8 WEEKS
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.
Percentage Change From Baseline in the Step Test
BASELINE AND 8 WEEKS
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.
Percentage Change in Functional Reach Test From Baseline
BASELINE AND 8 WEEKS
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.
Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
BASELINE AND 8 WEEKS
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.
Average Daily Dose of Acetaminophen Equivalent
8 WEEKS
Analgesic use (average daily dose of acetaminophen equivalent)

Who is running the study

Principal Investigator
F. F.
Felipe Fregni,,, MD PhD
Spaulding Rehabilitation Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes arthrosis?

The development of arthritis involves complex interactions between genetic susceptibility and environmental causes, which modify individual risk. Although there is still uncertainty about the relative contribution of genetics and environmental factors, the findings presented here provide an overview of the contribution of environmental triggers.

Anonymous Patient Answer

What is arthrosis?

Arthrosis is a chronic inflammation in the joint, in which inflammatory molecules and cytokines (e.g., cytokine-dependent recruitment to inflammatory sites, increased turnover, tissue destruction and increased numbers of chondrocytes and mesenchymal stem cells) are generated and perpetuate the inflammation.

Anonymous Patient Answer

How many people get arthrosis a year in the United States?

Arthrosis of the hip and knee affects less than 1% of adults. Given the fact that the incidence rate of arthrosis increases with age, a substantial proportion of older people with hip and knee arthrosis in the United States (especially younger men) are expected to be undiagnosed and untreated. Improved recognition of arthrosis in the United States will provide an opportunity for the implementation of effective strategies designed to prevent and delay the onset of disease.

Anonymous Patient Answer

Can arthrosis be cured?

There is no evidence that joint arthrosis can be cured and there is strong evidence of morbidity and death associated with arthroplasty procedures. Nevertheless, arthrosis is common. It is not clear, therefore, whether arthrosis is a chronic problem or whether it is just a symptom and not a disease in itself. If not an insidious disease, it is a sign of progressive and disabling loss of quality of life.

Anonymous Patient Answer

What are common treatments for arthrosis?

Most patients with hand arthrosis require nonoperative management, such as splinting, joint irrigation, and hand and wrist physiotherapy. If conservative measures are unsuccessful, or where it cannot be determined with diagnostic accuracy or patient comfort, an arthrodesis can be considered as a treatment option.

Anonymous Patient Answer

What are the signs of arthrosis?

Symptoms of arthrosis are similar to joint dysfunctions. This may result in long duration and difficulty with activities of daily living as well as in the workforce.

Anonymous Patient Answer

What is the average age someone gets arthrosis?

The first diagnosis of arthrosis is usually by age 30, and the average age after the initial diagnosis is 42.2 years. However, the average age of the third diagnosis is much earlier than that, being age 41.9 years old. The reasons in this case seem to be medical and psychological, possibly because people want to postpone the moment when they may have to undergo a replacement of the joint surface. In order to help people live longer, we ought to increase awareness of arthrosis and try to help people get over this disease as soon as possible.

Anonymous Patient Answer

Have there been any new discoveries for treating arthrosis?

There is not enough evidence to conclude whether a new medication is efficacious for treating arthrosis. Current therapies can help alleviate the symptoms associated with this disease.

Anonymous Patient Answer

How serious can arthrosis be?

Arthrosis has a major role in adult life. However, the seriousness of the condition of the arthrosis itself is dependent on several factors and the condition may in turn affect the quality of life of the patient. Arthrosis can be treated through surgical methods such as osteotomy, fusion and arthroplasty, of which it may also be a predisposing factor.

Anonymous Patient Answer

Is active low-intensity transcranial electrical stimulation/active transcranial ultrasound typically used in combination with any other treatments?

Low-intensity transcranial electrical stimulation/active transcranial ultrasound may be used alone or combined with other treatment modalities, depending on the patient. The use of active low-intensity transcranial electrical stimulation/active transcranial ultrasound alone may lead to a favorable change of the functional status, as well as clinical improvement with no additional side effects that may be associated with combined treatment.

Anonymous Patient Answer

Has active low-intensity transcranial electrical stimulation/active transcranial ultrasound proven to be more effective than a placebo?

Active low-intensity tTES/aRTUS is more effective than a placebo for the treatment of the signs and symptoms of subacromial impingement syndrome, thus demonstrating a clinically significant benefit of this kind of intervention. Further studies are needed to define the effects of active low-intensity tTES/aRTUS on functional recovery and to evaluate the long-term clinical efficacy of tTES/aRTUS.

Anonymous Patient Answer

Does arthrosis run in families?

Recent findings add to the accumulating evidence for the familial transmission of AAO. Recent findings adds further evidence to the emerging belief that the susceptibility gene for AAO does not reside within the genes for HAO. Whether other susceptibility genes exist for both AAO and HAO is yet to be determined with greater epidemiologic studies.

Anonymous Patient Answer
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