Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

March 5, 2026 updated by: The University of Texas Medical Branch, Galveston
The purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (LFU) that may or may not help healing.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

This initial study is a pilot study which is going to test the safety and efficacy of the developed ultrasound intervention for osteoarthritis, initially on osteoarthritis of the knee. This study is a pilot study to evaluate two distinct variables. The first is the safety and efficacy of the device, and the second is the potential impact the device may have on patients as their osteoarthritic joints react to the LFU, using patient-reported outcomes associated with this study. The ultrasound will be delivered at a frequency of 33 kHz at power levels of 4-10 Pascals with a program of 1.6 seconds on and 1.6 seconds off. The generators will be encased in epoxy within the Osteoarthritis baths. The intervention will be repeated on every second or third day to allow time for healing

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 777555
        • University of Texas Medical Branch, Galveston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
  2. Adults at least ≥40 years of age at the time of consent.
  3. Chronic knee pain within the past 6 months.

Exclusion Criteria:

  1. Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder.
  2. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
  3. History of replacement surgery, acupuncture therapy on the joint/knee under study within the past 6 months, or systemic corticosteroids within the study period and previous 30 days.
  4. Subject's vitals are unstable or not in range for a safe study visit.
  5. History of fecal incontinence.
  6. Vomiting/Diarrheal illness within the past 7 days or at any time during the study.
  7. Any clinically significant rash or formation of rashes or open sores, boils or infected wounds two weeks prior to or during the study.
  8. Laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days (eg. vancomycin resistant enterococcus, methicillin-resistant Staphylococcus, Candida auris, extended- spectrum beta lactamase bacteria)
  9. History of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
  10. Females who are pregnant or lactating.
  11. Inability to comply with study protocol.
  12. Incarcerated individuals.
  13. Non-English speaking subjects.
  14. Participant's weight must be </= 350 lbs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Frequency Ultrasound (LFU) 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.
Device: Low Frequency Ultrasound Therapy
The ultrasound will be delivered at a frequency of 33 kHz at power levels of 4-10 Pascals with a program of 1.6 seconds on and 1.6 seconds off. The generators will be encased in epoxy within the Osteoarthritis baths. The intervention will be repeated on every second or third day to allow time for healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant-Reported Safety and Efficacy Following Use of Investigational Device
Time Frame: From device use through completion of the final study visit, up to one year
The number of participants who report any device-related safety concerns following use of the investigational non-significant risk device, as assessed by participant-reported surveys.
From device use through completion of the final study visit, up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with Osteoarthritic Joints Reaction to the LFU
Time Frame: one year
To determine the potential impact the device may have on patients as their osteoarthritic joints react to the LFU, which will be denoted by surveys.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Thomas Blackwell, University of Texas Medical Branch, Galveston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0164

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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