Ultrasound Therapy for Osteoarthritis

Overseen By Thomas Blackwell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Systemic corticosteroids

Disqualifiers: Arthritis, Surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Varies, up to one year

10 Participants Needed

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.

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

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.

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:

• Wound cleaning and maintenance debridement
• Chronic venous leg ulcers
• Diabetic foot ulcers

Approved in European Union as Low Frequency Ultrasound Therapy for:

• Wound healing
• Chronic wounds
• Musculoskeletal conditions

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Findings from Research

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.

NCBI (Pubmed)

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. 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

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]

A novel, wearable ultrasound platform showed a significant pain reduction of up to 52% in patients with knee osteoarthritis during two pilot studies.

Initial data suggests that ultrasound therapy may also improve mobility in patients with mild to moderate knee arthritis, indicating potential clinical benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis. Langer, MD., Levine, V., Taggart, R., et al.[2020]

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]

Low-intensity pulsed ultrasound (LIPUS) can stimulate chondrocyte proliferation and inhibit inflammatory pathways, making it a promising non-invasive treatment option for mild to moderate osteoarthritis (OA).

This review highlights the need for further comprehensive studies on LIPUS, as it has shown potential in activating cellular pathways that could improve cartilage health and function in OA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Potential Low-Intensity Pulsed Ultrasound for Osteoarthritis: Pre-clinical and Clinical Perspectives. Uddin, SMZ., Komatsu, DE.[2021]

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]

Therapeutic ultrasound may provide significant pain relief for patients with knee osteoarthritis, showing a reduction in pain scores by an average of 1.2 cm on a 10-cm scale compared to control groups.

While there was a trend suggesting improved function with ultrasound treatment, the evidence quality was low, and no adverse events were reported, indicating that ultrasound is generally safe for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic ultrasound for osteoarthritis of the knee or hip. Rutjes, AW., Nüesch, E., Sterchi, R., et al.[2022]

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]