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New treatment option for Bone Fracture
Official title Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
ClinicalTrials.gov ID: NCT05883241
What this study is testing
What is 2.5% Diclofenac Patches?
2.5% Diclofenac Patches is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for bone fracture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Have physician-diagnosed bone fracture
- Are between 18-80 years of age
- Report a pain score between 3-7 (range: 0-10) prior to enrolment
- Report that pain from fracture negatively affects quality of life
- Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the...
You likely can't join if
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to...
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Is pregnant.
- Is a prisoner.
- Is non-ambulatory (unable to walk).
See the full eligibility criteria
- Have physician-diagnosed bone fracture
- Are between 18-80 years of age
- Report a pain score between 3-7 (range: 0-10) prior to enrolment
- Report that pain from fracture negatively affects quality of life
- Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study
- Are deemed appropriate by their physician or by the study site physician to participate.
- Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study...
- Not use or initiate opioid and/or non-opioid analgesic medications.
- Be willing to discontinue any other treatment treatment modalities on the affected area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
- Cannot successfully demonstrate the ability to put on and take off the device.
- 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.
- Is pregnant.
- Is a prisoner.
- Is non-ambulatory (unable to walk).
- Has a pacemaker.
- Has a malignancy in the treatment area.
- Has an active infection, open sores, or wounds in the treatment area.
- Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
- Has a known neuropathy (disease of the brain or spinal nerves).
- Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
- Are currently taking steroids.
The study team makes the final eligibility decision.
Where it's taking place
- Trumbull, Connecticut, United States
- Lansdowne, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Trumbull, Connecticut, United States; Lansdowne, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.