SUSPENDED

Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

Conditions

Osteo Arthritis Knee Age Related Osteoporosis Pain Knee Joint Contracture Knee Ultrasound Joint mobility

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

Quick Facts

Study Start:2024-07-31

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT06562374

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Thomas Blackwell

PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Study Locations (Sites)

University of Texas Medical Branch, Galveston

Galveston, Texas, 777555

United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Thomas Blackwell, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-07-31

Study Completion Date2026-02

Study Record Updates

Study Start Date2024-07-31

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

Pain
Osteo Arthritis Knee
Knee
Ultrasound
Joint mobility

Additional Relevant MeSH Terms

Osteo Arthritis Knee
Age Related Osteoporosis
Pain
Knee Joint Contracture