10 Participants Needed

Ultrasound Therapy for Osteoarthritis

LC
TB
Overseen ByThomas Blackwell
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Medical Branch, Galveston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking systemic corticosteroids, you must not have used them within the study period and the previous 30 days.

How is Low Frequency Ultrasound Therapy different from other treatments for osteoarthritis?

Low Frequency Ultrasound Therapy is unique because it is a non-invasive treatment that uses sound waves to provide mechanical stimulation to the cartilage, promoting cell growth and reducing inflammation, unlike traditional treatments that often rely on medications or surgery.12345

What data supports the effectiveness of the treatment Low Frequency Ultrasound Therapy for Osteoarthritis?

Research shows that long-duration, low-intensity ultrasound can reduce pain by up to 52% and improve mobility in people with knee osteoarthritis. Additionally, low-frequency ultrasound has been effective in other conditions, like pulmonary tuberculosis, suggesting it may help in osteoarthritis as well.12678

Who Is on the Research Team?

TB

Thomas Blackwell

Principal Investigator

University of Texas Medical Branch, Galveston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures
I am 40 years old or older.
I have had knee pain for the last 6 months.

Exclusion Criteria

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
Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
I have not had vomiting or diarrhea in the last week.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low frequency ultrasound (LFU) intervention for osteoarthritis, with sessions every second or third day

Varies, up to one year
Multiple visits (in-person) every 2-3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys to assess outcomes

One year

What Are the Treatments Tested in This Trial?

Interventions

  • Low Frequency Ultrasound Therapy
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Low Frequency Ultrasound (LFU) InterventionExperimental Treatment1 Intervention

Low Frequency Ultrasound Therapy is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Low Frequency Ultrasound Therapy for:
🇪🇺
Approved in European Union as Low Frequency Ultrasound Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials
263
Recruited
55,400+

Published Research Related to This Trial

In a study of 90 patients with knee osteoarthritis, long-duration low-intensity ultrasound therapy significantly reduced pain by an average of 1.96 points on a numeric rating scale over 6 weeks, compared to only 0.85 points in the placebo group.
The active treatment group also showed a significant improvement in functional scores, with a 505-point increase compared to 311 points in the placebo group, indicating that this non-invasive therapy can effectively enhance joint function in patients with knee osteoarthritis.
Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study.Draper, DO., Klyve, D., Ortiz, R., et al.[2019]
Low dose ultrasound therapy has been used for over 50 years, showing some effectiveness in treating conditions like ulcus cruris and lateral epicondylitis, based on limited clinical trials.
However, there is a lack of placebo-controlled studies for many other conditions, making it difficult to draw definitive conclusions about the overall efficacy of low dose ultrasound therapy.
[Critical evaluation of ultrasound therapy].Ebenbichler, G., Resch, KL.[2006]
In a study involving 50 new cases of pulmonary tuberculosis, the group receiving low-frequency ultrasound (LFU) treatment alongside standard therapy showed a higher response to treatment compared to the control group that only received standard therapy.
The results suggest that LFU can be a beneficial adjuvant treatment for pulmonary tuberculosis, enhancing the effectiveness of conventional therapies.
[The use of low-frequency ultrasound in the combined therapy of pulmonary tuberculosis patients].Samosiuk, IZ., Miasnikov, VG., Klimenko, IV.[2006]

Citations

Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. [2019]
[Critical evaluation of ultrasound therapy]. [2006]
3.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[The use of low-frequency ultrasound in the combined therapy of pulmonary tuberculosis patients]. [2006]
Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis. [2020]
LIPUS Alleviates Knee Joint Capsule Fibrosis in Rabbits by Regulating SOD/ROS Dynamics and Inhibiting the TGF-β1/Smad Signaling Pathway. [2023]
Therapeutic Potential Low-Intensity Pulsed Ultrasound for Osteoarthritis: Pre-clinical and Clinical Perspectives. [2021]
Improved cartilage repair after treatment with low-intensity pulsed ultrasound. [2019]
Therapeutic ultrasound for osteoarthritis of the knee or hip. [2022]
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