Ultrasound Therapy for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Blackwell

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Systemic corticosteroids

Disqualifiers: Arthritis, Surgery, Pregnancy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

Research Team

Thomas Blackwell

Principal Investigator

University of Texas Medical Branch, Galveston

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Low Frequency Ultrasound Therapy (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.

Participant Groups

Group I: Low Frequency Ultrasound (LFU) Intervention Experimental Treatment 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas Medical Branch, Galveston Galveston, TX

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Patients Recruited

55,400+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of low-frequency ultrasound in the combined therapy of pulmonary tuberculosis patients]. Samosiuk, IZ., Miasnikov, VG., Klimenko, IV.[2006]

Low-intensity pulsed ultrasound (LIPUS) effectively reduces knee joint capsule fibrosis and arthrogenic contracture in rabbits by decreasing reactive oxygen species (ROS) levels and inhibiting the TGF-β1/Smad signaling pathway, which are both elevated due to immobilization.

The study involved rabbits with immobilized knee joints for 6 weeks, followed by various remobilization and LIPUS treatment periods, demonstrating that LIPUS can counteract the negative effects of immobilization on joint health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LIPUS Alleviates Knee Joint Capsule Fibrosis in Rabbits by Regulating SOD/ROS Dynamics and Inhibiting the TGF-β1/Smad Signaling Pathway. Zhou, T., Zhou, CX., Zhang, QB., et al.[2023]

In a study involving 106 adult male New Zealand rabbits, daily low-intensity pulsed ultrasound therapy significantly improved the healing of full-thickness osteochondral defects, leading to better cartilage repair compared to untreated controls.

Increasing the treatment duration to 40 minutes daily further enhanced the histologic quality of the repair cartilage, indicating that longer ultrasound therapy may optimize healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved cartilage repair after treatment with low-intensity pulsed ultrasound. Cook, SD., Salkeld, SL., Popich-Patron, LS., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. [2019]

2. Austria pubmed.ncbi.nlm.nih.gov

[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]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

LIPUS Alleviates Knee Joint Capsule Fibrosis in Rabbits by Regulating SOD/ROS Dynamics and Inhibiting the TGF-β1/Smad Signaling Pathway. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Therapeutic Potential Low-Intensity Pulsed Ultrasound for Osteoarthritis: Pre-clinical and Clinical Perspectives. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Improved cartilage repair after treatment with low-intensity pulsed ultrasound. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Therapeutic ultrasound for osteoarthritis of the knee or hip. [2022]