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Behavioural Intervention

Ultrasound Stimulation for Arthritis

Houston, TX

N/A

Recruiting

Research Sponsored by Surf Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy Volunteer Population: 22-75 years of age

Healthy Volunteer Population: Weigh at least 40 kg

Must not have

Healthy Volunteer Population: Any physical disabilities, conditions, or diseases that limit the capacity to participate in study procedures or increase the risk of harm as determined by the study PI

Inflammatory Arthritis Population: Active use of tobacco/nicotine products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 2 hours and 24 hours post therapy

Summary

This trial aims to see if a special type of ultrasound can reduce inflammation in people with Inflammatory Arthritis compared to a fake treatment. They will look at changes in certain markers of inflammation in the blood

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Who is the study for?

This trial is for healthy individuals and those with various forms of inflammatory arthritis, such as rheumatoid arthritis and ankylosing spondylitis. Participants should be willing to undergo ultrasound stimulation sessions.Check my eligibility

What is being tested?

The study tests if non-invasive ultrasound can reduce inflammation compared to a sham (placebo) intervention in people with inflammatory arthritis. Blood levels of inflammation markers are measured before and after the treatment.See study design

What are the potential side effects?

Since the trial involves non-active or active ultrasound stimulation, side effects may include mild discomfort at the site of application but generally, this method is considered safe with minimal risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 75 years old.

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I weigh at least 40 kg.

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I weigh at least 40 kg.

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I have been diagnosed with Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis for at least 6 months.

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I can keep taking my current arthritis medication at the same dose during the study.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health conditions that would prevent me from safely participating in a study.

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I currently use tobacco or nicotine products.

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I currently have an active bacterial or viral infection.

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My condition weakens my immune system significantly.

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I have a BMI of 35 or higher and am part of the inflammatory arthritis population.

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I have a long-term implanted medical device like a pacemaker.

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I have fibromyalgia or a similar condition that is not well-controlled.

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I do not have any active bacterial or viral infections.

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I am a healthy volunteer with a BMI of 35 or higher.

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I have an enlarged spleen, no spleen, or have had my spleen removed.

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I have started a new arthritis medication within the last 3 months or might start one during the study.

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I am receiving chemotherapy or immunotherapy for cancer.

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I have a wound, rash, infection, or injury on the area affected by arthritis.

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I have had a vagal nerve injury or surgery to cut the vagus nerve.

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I have heart problems that affect my daily life.

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I have kidney disease stage 3 or worse.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 2 hours and 24 hours post therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 2 hours and 24 hours post therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 hours and 24 hours post therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor Necrosis Factor Alpha Concentration Differences

Secondary study objectives

Interleuken 1b Concentration Difference

Interleuken IL-6 Concentration Difference

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Participants will receive active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table

Group II: ControlPlacebo Group1 Intervention

Participants will receive a non-active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table

0 / 21Eligibility criteria met