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Ultrasound Therapy

Ultrasound Therapy for Osteoarthritis

N/A

Recruiting

Led By Thomas Blackwell

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

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

Must have

Adults at least ≥40 years of age at the time of consent

Chronic knee pain within the past 6 months

Must not have

Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder

Vomiting/Diarrheal illness within the past 7 days or at any time during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new ultrasound bath device that uses low frequency ultrasound to see if it is safe and effective in helping with healing.

Who is the study for?

This trial is for individuals with conditions like arthritis, osteoporosis, and knee contractures. Participants should be experiencing pain or limited movement due to these issues. Specific eligibility details are not provided but typically include age, health status, and severity of condition.

What is being tested?

The study is testing the safety and effectiveness of a new experimental ultrasound bath device that delivers low frequency ultrasound therapy to see if it helps in healing and rehabilitation for those with joint problems.

What are the potential side effects?

Potential side effects are not detailed here; however, common side effects from similar treatments may include mild discomfort at the treatment site or temporary skin irritation.

Eligibility Criteria

Inclusion Criteria

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

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I am 40 years old or older.

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I have had knee pain for the last 6 months.

Exclusion Criteria

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

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I have a type of arthritis that is not osteoarthritis.

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I have not had vomiting or diarrhea in the last week.

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I haven't had significant rashes, sores, or infections in the last two weeks.

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I am not pregnant or breastfeeding.

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My weight is 350 lbs or less.

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My vital signs are not stable enough for safe participation in the study.

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I have a history of losing control of my bowels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and Efficacy for non significant risk device

Secondary study objectives

Participants with Osteoarthritic Joints Reaction to the LFU

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Low Frequency Ultrasound (LFU) InterventionExperimental Treatment1 Intervention

Subjects will be given ultrasound at a frequency of 33 kHz with a program of 1.6 seconds on and 1.6 seconds off for 30 min at either a power level of 4 or 10 Pascals to determine which power level is optimal for osteoarthritis. Follow up visits after two-three days will be used to continue therapy.

0 / 9Eligibility criteria met