SAM + Diclofenac for Broken Bone Pain

Recruiting at 2 trial locations

Overseen By George K. Lewis, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ZetrOZ, Inc.

Must not be taking: Steroids

Disqualifiers: Pregnancy, Non-ambulatory, Pacemaker, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special ultrasound device (Sustained Acoustic Device), used with a diclofenac patch, can ease pain from broken bones. Participants will use the device and patch regularly for 12 weeks. The study also examines whether this approach helps people return to work sooner. It may be suitable if you have a doctor-confirmed bone fracture, experience daily pain that affects your life, and are willing to use the device as instructed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering the opportunity to be among the first to receive this innovative treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop using any opioid and non-opioid pain medications and any other treatments on the affected area during the study.

What prior data suggests that this ultrasound device is safe for treating bone-fracture pain?

Research has shown that Sustained Acoustic Medicine (SAM) is a safe and well-tolerated treatment for various types of pain. Studies have found SAM to be effective, non-invasive, and easy to use. The FDA has approved it for home use, indicating a strong safety record. Users of SAM for muscle and joint injuries have reported good results, with no major side effects.

Regarding the diclofenac patch used with SAM, diclofenac is a common topical pain relief medication. It is generally well-tolerated, with side effects mostly limited to skin irritation in some cases.

In summary, both the SAM device and the diclofenac patch have demonstrated safety in other conditions, so they are expected to be safe in this trial as well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of the SAM Ultrasound Device and diclofenac patch for broken bone pain because it introduces a novel approach to pain management. Unlike standard treatments like oral pain medications or conventional topical gels, this method uses the SAM Device to deliver continuous ultrasound waves, potentially enhancing the healing process and pain relief. Additionally, the diclofenac patch provides targeted anti-inflammatory effects directly at the site of the injury, which could reduce systemic side effects often seen with oral medications. This dual approach aims to offer faster and more effective pain relief than current options.

What evidence suggests that the SAM Ultrasound Device and Diclofenac Patch could be effective for bone-fracture pain?

In this trial, participants will receive treatment with the SAM Ultrasound Device combined with a diclofenac patch. Research has shown that Sustained Acoustic Medicine (SAM) can reduce pain and improve movement in individuals with muscle and joint injuries. One study found that regular use of ultrasound therapy is safe and effective for pain relief. SAM employs gentle ultrasound to aid bone healing and alleviate pain. When combined with a diclofenac patch, a pain-relief medication, SAM has demonstrated good results in managing symptoms. This combination may help individuals recover faster and resume daily activities. ^{1 2 3 4 6}

Who Is on the Research Team?

George K. Lewis, Ph.D.

Principal Investigator

ZetrOZ Systems

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a physician-diagnosed bone fracture, experiencing moderate pain that affects their quality of life. Participants must not use other pain treatments or start new medications during the study and should be able to apply the treatment themselves.

Inclusion Criteria

My fracture pain lowers my quality of life.

I agree to stop any other treatments like TENS or ultrasound on the affected area during the study.

Report a pain score between 3-7 (range: 0-10) prior to enrolment

Exclusion Criteria

I am unable to walk.

Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions

Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SAM Ultrasound Device treatment combined with diclofenac patch for 12 weeks

12 weeks

Daily self-application

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sustained Acoustic Device

Trial Overview The trial tests if Sustained Acoustic Medicine (SAM), combined with a Diclofenac patch, can reduce pain from bone fractures over 12 weeks better than just the Diclofenac patch alone. It also looks at whether SAM helps patients return to work sooner.

How Is the Trial Designed?

Group I: SAM Ultrasound Device and Diclofenac Patch Experimental Treatment 2 Interventions

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm\^2 intensity.

Who Is Running the Clinical Trial?

ZetrOZ, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+

Published Research Related to This Trial

Sustained acoustic medicine (SAM) is effective for treating musculoskeletal injuries, with 68.9% of patients showing clinical improvement in under 2 weeks and a significant reduction in pain medication use by 50%.

Athletic trainers reported high confidence in SAM's ability to improve function and facilitate return to work within 30 days, highlighting its safety and versatility as a noninvasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Sustained Acoustic Medicine for Treating Musculoskeletal Injuries in Military and Sports Medicine. Walters, R., Kasik, J., Ettel, C., et al.[2023]

In a study of 122 patients with acute lower limb injuries, dexketoprofen trometamol was found to be an effective analgesic, showing a significant reduction in pain scores compared to diclofenac at various time points (15, 30, 45, and 60 minutes).

Dexketoprofen demonstrated a faster onset of pain relief, with higher odds ratios for achieving a decrease in pain score of at least 1 or 2 points on an 11-point scale, indicating it may provide quicker and more effective pain management for acute musculoskeletal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of the onset of analgesic efficacy of dexketoprofen and diclofenac in lower limb injury. Leman, P., Kapadia, Y., Herington, J.[2019]

The study demonstrated that using a wearable sonophoresis device significantly enhances the delivery of diclofenac gel through the skin, increasing drug delivery by 3.8 times and penetration by 32% compared to standard topical application.

This method of transdermal drug delivery could improve the efficacy of NSAIDs like diclofenac in managing arthritis pain, offering a promising alternative to traditional topical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained acoustic medicine; sonophoresis for nonsteroidal anti-inflammatory drug delivery in arthritis. Masterson, J., Kluge, B., Burdette, A., et al.[2023]

In a study of 88 patients with ankle fractures, those treated with Diclofenac sodium sustained-release capsules alongside function training experienced significantly lower pain levels post-surgery compared to those receiving conventional analgesics (p<0.05).

The experimental group also showed higher treatment compliance rates (97.73%) compared to the control group (79.55%), suggesting that the combination of Diclofenac and function training not only alleviates pain but also enhances patient adherence to recovery protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of diclofenac sodium sustained-release capsules in conjunction with function training and VAS score after ankle fracture surgery. Liu, ZF., Qiu, ZY., Zhang, Y., et al.[2023]

In a study of 32 patients with knee osteoarthritis, the combination of Sustained Acoustic Medicine (SAM) ultrasound therapy and a 1% diclofenac gel significantly reduced pain by an average of 2.06 points (50%) on a pain scale over one week, with 75% of patients showing rapid improvement after the first treatment.

The treatment also led to a significant improvement in function, as measured by the WOMAC score, with over 95% of participants reporting the device as safe, effective, and easy to use, indicating its potential as a non-invasive option for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Madzia, A., Agrawal, C., Jarit, P., et al.[2022]

Therapeutic ultrasound at a dose of 0.4 w/cm2 for 5 minutes significantly increased pressure pain thresholds in the masseter muscle and raised intraoral temperature compared to sham ultrasound in 20 female subjects with masseter myalgia.

However, there was no significant difference in overall pain intensity or in the pressure pain thresholds of the temporalis muscle, indicating that the ultrasound's effects were localized to the masseter muscle without broader segmental benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Effect of Continuous Ultrasound vs Sham Ultrasound for Bilateral Masseter Myalgia: A Double-Blinded Trial. Hussain, H., Crow, H., Gonzalez, Y., et al.[2018]

Sustained Acoustic Medicine (SAM) is a non-invasive treatment that has shown effectiveness in reducing pain and improving function in patients with musculoskeletal injuries, based on a review of 13 clinical studies involving 372 participants.

SAM can be a beneficial adjunct therapy for patients who do not respond to traditional physical therapy, offering a safe and effective option for promoting tissue recovery and facilitating a return to work.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis. Winkler, SL., Urbisci, AE., Best, TM.[2021]

In a systematic review of 34 studies involving 4,431 patients, both ibuprofen and diclofenac were found to be effective analgesics for post-operative pain, with similar efficacy in achieving at least 50% pain relief.

The number-needed-to-treat for achieving significant pain relief was slightly better for diclofenac (1.8 for 100 mg) compared to ibuprofen (2.4 for 600 mg), indicating that diclofenac may be more effective at lower doses, but the choice between the two should consider factors like safety and cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral ibuprofen and diclofenac in post-operative pain: a quantitative systematic review. Collins, SL., Moore, RA., McQuay, HJ., et al.[2022]

Phonophoresis (PP) using a combination of diclofenac and Thiocolchicoside gel significantly improved outcomes for patients with acute low back pain compared to routine ultrasound treatment with a non-therapeutic gel, particularly in the Oswestry Disability Index (ODI) at 6 weeks post-treatment.

Both treatment methods showed improvements in pain and disability, but PP demonstrated superior efficacy in reducing disability and improving overall function in the short term, indicating it may be a more effective option for managing acute low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of diclofenac & thiocolchioside gel phonophoresis comparison with ultrasound therapy on acute low back pain; a prospective, double-blind, randomized clinical study. Altan, L., Kasapoğlu Aksoy, M., Kösegil Öztürk, E.[2018]

In a clinical trial with 18 participants suffering from chronic masticatory muscle pain, sodium diclofenac (an NSAID) provided significant pain relief by the third day of treatment, demonstrating its efficacy as an adjuvant therapy with occlusal splint therapy.

All treatments, including a combination therapy and placebo, were effective for pain relief, but the placebo only showed effects by the eighth day, highlighting the faster action of sodium diclofenac compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia evaluation of 2 NSAID drugs as adjuvant in management of chronic temporomandibular disorders. Kurita Varoli, F., Sucena Pita, M., Sato, S., et al.[2022]

In a study of 48 children aged 5 to 15 after tonsillectomy, diclofenac provided slightly better pain relief at specific times compared to high-dose acetaminophen, but overall, both medications were similarly effective.

Diclofenac was associated with a lower incidence of nausea and vomiting compared to acetaminophen, making it a potentially safer option for postoperative pain management in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diclofenac or acetaminophen for analgesia in paediatric tonsillectomy outpatients. Rømsing, J., Ostergaard, D., Drozdziewicz, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9869494/

Evaluation of Sustained Acoustic Medicine for Treating ... The objective of this study was to evaluate the efficacy of SAM treatment for musculoskeletal injuries and accelerated recovery. Methods: An 18-question ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05883241

Sustained Acoustic Medicine (SAM) for Symptomatic ... This is a 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05883241?term=ultrasound%20therapy&aggFilters=status:rec%20enr%20act,studyType:int,phase:0%201%202%203%204&viewType=Table&rank=5

Sustained Acoustic Medicine (SAM) for Symptomatic ... The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a ...

4. openorthopaedicsjournal.com openorthopaedicsjournal.com/VOLUME/14/PAGE/176/FULLTEXT/

Sustained Acoustic Medicine Combined with A Diclofenac ... The authors concluded that regular ultrasound treatment is safe and effective at relieving pain and improving physical function in patients with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9854278/

Critical survey and panel review of sustained acoustic ... Ultrasound is effective for fracture healing and enhances bone remodeling, and the panel has used SAM to increase bone healing of stress fractures. SAM is one ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11492000/

Sustained acoustic medicine treatment of discogenic chronic ... SAM treatment is well-tolerated by patients and may be considered a safe, non-invasive treatment option for chronic discogenic, lower back pain. Keywords: Low ...