FDA approved ultrasound system with shear wave elastography capability for Syndrome

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Arizona, Scottsdale, AZ
Syndrome+1 More
FDA approved ultrasound system with shear wave elastography capability - Device
Eligibility
18+
All Sexes
Eligible conditions
Syndrome

Study Summary

This study is evaluating whether ultrasound can be used to detect stiffness problems in wrists.

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Eligible Conditions

  • Syndrome
  • Carpal Tunnel Syndrome

Treatment Effectiveness

Study Objectives

This trial is evaluating whether FDA approved ultrasound system with shear wave elastography capability will improve 1 primary outcome and 1 secondary outcome in patients with Syndrome. Measurement will happen over the course of First 3 months.

3 to 6 months
Correlate shear wave elastography (SWE) measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX) elasticity
First 3 months
Evaluate the treatment response by shear wave elastography (SWE)

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Operative treatment (surgical decompression) for carpal tunnel syndrome

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. FDA Approved Ultrasound System With Shear Wave Elastography Capability is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Operative treatment (surgical decompression) for carpal tunnel syndrome
Device
Shear wave elastography (SWE) will be used to assess the stiffness of tissue. Patients will be revaluated at 3 and 6 months post-operatively. Patient will sit done in a chair. The investigators will scan the wrist area of both arms to acquire SWE map. This imaging will be done before the treatment. We will repeat the imaging study at 3 and 6 months after the treatment. Each ultrasound imaging session will take about less than 10 min. The investigators do not expect any discomfort during the imaging.
Corticosteroid injection treatment for carpal tunnel syndrome
Device
Shear wave elastography (SWE) will be used to assess the stiffness of tissue. Patients will be revaluated after 6 weeks following corticosteroid injection. Patient will sit done in a chair. The investigators will scan the wrist area of both arms to acquire SWE map. The investigators do not expect any discomfort during the imaging.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 to 6 months for reporting.

Who is running the study

Principal Investigator
A. A.
Azra Alizad, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Arizona - Scottsdale, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Having unilateral symptom of wrist pain
Male and female volunteers.
Age ≥ 18 years old.
Scheduled for corticosteroid injection or surgery

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 is the latest research for syndrome?

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Significant research updates, including recent papers on the development of clinical criteria, are published in some syndromes. However, research updates are difficult to find in some areas of information.

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What are the signs of syndrome?

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The criteria set by the American Academy of Child and Adolescent Psychiatry for diagnostic syndrome status are met in a variable percentage of children presenting with problems. Further discussion is warranted regarding specific criteria.

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Does syndrome run in families?

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In a recent study, findings suggest that it is not the occurrence of familial idiopathic gastric cancer in a family that indicates a genetic predisposition for the syndrome, a risk factor or a predisposition for gastric cancer in its occurrence.

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Can syndrome be cured?

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Findings from a recent study suggest that schizophrenia does not have a cure. More research is needed to identify effective pharmacospecific psychotherapies for schizophrenia and its prodromal phase.

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What causes syndrome?

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Although some people with chronic fatigue syndrome have no psychiatric history, some have a history involving psychiatric symptoms. While the exact causal pathogenesis remains elusive, the common finding of many patients that they experience pain and fatigue in the chest region suggests that this be the area affected. The common association with anxiety and pain/fever in association to fatigue in this population suggests [that there may be a link between chronic stress, anxiety or pain and chronic fatigue syndrome in the lung (see below)(see also stress-related fatigue#Clinical studies concerning chronic fatigue syndrome, (CFS)).[Power(http://www.withpower.

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

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At least 1 in 30 or 1 in 100 is affected by the syndrome every year in the United States. The syndrome is more common in women. By the 1990s the number of individuals affected by the syndrome had jumped to 1 in 150,000. The U.S. population probably has the syndrome at current rates for two reasons. First, it is not recognized as a disease. Second, the syndrome is not properly diagnosed by doctors, despite all the signs. When it is recognized by doctors, it is often diagnosed incorrectly. In the 1990s, when syndrome was first recognized, some doctors did not believe that syndrome was a real disorder. For example, a doctor said that it was more common than multiple sclerosis.

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What is syndrome?

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Syndromes can be defined based on disease type. An example of a disease syndrome from this point of view includes polycystic kidney disease and MTHFR deficiency. This syndrome can only be seen clinically if all affected persons have been carefully followed with a thorough history and physical examination to exclude alternative diseases.

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What are common treatments for syndrome?

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(1) A combination of behavioural and pharmacological therapy is the most common treatment for syndromes such as anxiety, bipolar disorder and dementia; (2) antidepressant medications should be discussed with patients with depressive symptoms (and other patients who do not respond to other treatments); (3) CBT should be the treatment of choice for those with psychosis (and for psychosis prevention); (4) medications that can treat insomnia include sedative-hypnotics and antidepressants; and (5) CBT is used as a monotherapy in patients with bipolar disorder, and is often also prescribed in older patients with Alzheimer syndrome; in younger patients, stimulant medications are often used.

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What is the primary cause of syndrome?

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We found that patients in the primary and secondary analysis may have been diagnosed with syndrome at other hospitals, but it is difficult to identify when syndrome may have been present. The primary and secondary studies do not give an exact cause of syndrome, but rather suggest a group of possible causes from disease or injury.

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Is fda approved ultrasound system with shear wave elastography capability safe for people?

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SWTE at the 3 frequencies with a 7-10 MHz ultrasound device does not have any safety concern for healthy subjects. Clinicians should avoid excessive use of the ultrasound machine to exclude excessive skin bruising.

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Have there been any new discoveries for treating syndrome?

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There are many different treatment options for patients with CVS, but there seems to be a huge gap between the treatments and the people that have the CVS, and it seems that they are all treated like they weren't having the CVS. I think this is a huge problem with the current treatments. I feel like most people are receiving medications, but many of them don't know what the side effects are and don't know how to take their medication appropriately. In this way, we need a more personalized treatment approach for people with CVS.

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What is the average age someone gets syndrome?

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This is the first study to provide national estimates of different syndrome age-groups, and it shows that one in eight people is affected by a syndrome in their lifetime. In a recent study, findings will help researchers build better models for syndromic populations including the elderly. In a recent study, findings of this study can be used for future incidence-related, or population-based studies for syndromic populations.

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