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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound device to determine its safety and effectiveness in helping with osteoarthritis, a condition causing joint pain and stiffness. The device uses low-frequency sound waves, known as Low Frequency Ultrasound Therapy, to potentially promote healing in affected knee joints. Individuals with chronic knee pain for at least six months may be suitable candidates for this trial. This research could uncover a better way to manage osteoarthritis pain and enhance daily life for those affected. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to improved osteoarthritis treatments.

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 prior data suggests that this ultrasound device is safe for osteoarthritis?

Studies have shown that low frequency ultrasound (LFU) therapy is safe for people with osteoarthritis. Research indicates that this type of ultrasound can reduce pain and improve movement without causing harm. In one study, participants used a similar ultrasound treatment and reported no negative side effects during or after therapy. Another study found that using ultrasound for a longer duration at low intensity reduced pain by more than half and improved joint movement. Overall, LFU therapy appears well-tolerated and effective for relieving osteoarthritis symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for osteoarthritis, which often involve medications like NSAIDs or corticosteroid injections, Low Frequency Ultrasound (LFU) Therapy uses sound waves to alleviate pain and improve joint function. Researchers are excited about LFU because it offers a non-invasive approach, potentially reducing the reliance on medications that can have side effects. Additionally, this therapy has a precise mechanism: it uses sound waves at a specific frequency and power to target the affected area, which may enhance tissue healing and provide faster relief. This innovative approach could be a game-changer for managing osteoarthritis symptoms more effectively and safely.

What evidence suggests that this ultrasound therapy is effective for osteoarthritis?

Research shows that low-intensity pulsed ultrasound (LIPUS) can help treat osteoarthritis (OA). Studies have found that it significantly reduces pain and improves knee function. In one study, ultrasound therapy reduced pain by up to 52% and improved mobility in individuals with knee OA. Another study found that patients using focused LIPUS experienced greater pain relief and better knee function than those who received a placebo treatment. This trial will evaluate Low Frequency Ultrasound Therapy by testing different power levels to determine the optimal setting for managing OA symptoms effectively. ^{1 3 4 6 7}

Who Is on the Research Team?

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.

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?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11061361/

Effectiveness of low-intensity pulsed ultrasound on osteoarthritis Numerous research studies have validated the effectiveness of low-intensity pulsed ultrasound (LIPUS) in OA treatment.

2. nature.com nature.com/articles/srep35453

Efficacy of focused low-intensity pulsed ultrasound therapy ... Compared with sham, patients receiving FLIPUS treatment showed statistically significant improvements in all pain, knee functional ability, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06562374

Low Frequency Ultrasound for Osteoarthritis Healing and ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1063458410002128

Efficacy of ultrasound therapy for the management of knee ... US could be efficacious for decreasing pain and may improve physical function in patients with knee OA. The findings of this review should be confirmed using ...

5. withpower.com withpower.com/trial/phase-arthritis-6-2024-b7909

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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11288152/

Evaluation of the effect of low-intensity pulsed ultrasound in ... Studies have proven that therapeutic ultrasound is a safe treatment to relieve pain and improve physical function in patients with KOA,17 in ...

7. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-018-0965-0

Effect of low-intensity long-duration ultrasound on the ... Long-duration low-intensity ultrasound significantly reduced pain and improved joint function in patients with moderate to severe osteoarthritis knee pain.