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SAM + Diclofenac for Osteoarthritis
Study Summary
This trial tests if low-intensity ultrasound can reduce knee Osteoarthritis pain and improve joint function over 8 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am unable to walk.I am currently on steroids.I have an infection or open wounds in the area that would be treated.My doctor says I have mild to moderate knee arthritis.I am between 35 and 80 years old.My pain level has been between moderate to severe in the past week.I agree not to use any skin products other than what's given to me in the study.I can take my treatment by myself every day, except when in water.I agree to stop any knee treatments like TENS during the study.My arthritis is caused by another health condition.I have a diagnosed nerve condition.My knee pain worsens my quality of life.I have a genetic condition that causes excessive bleeding.I am not using and will not start using painkillers.I haven't had knee surgery or injections in the affected knee in the last 6 months.I have numbness in the area to be treated, possibly due to chemotherapy or anesthesia.I cannot put on or take off the device by myself.I have cancer in the area that will be treated.You have been diagnosed with knee osteoarthritis by a doctor using specific guidelines from the American College of Rheumatology.
- Group 1: SAM Ultrasound Device and Diclofenac Patch
- Group 2: SAM Ultrasound Device and SAM Patch
- Group 3: Diclofenac Patch
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do the qualifications for this trial extend to people of advanced age?
"According to the enrollment criteria for this particular trial, candidates must be aged between 35 and 80 years old. There are 85 medical trials targeting minors under 18 and 934 studies focused on patients over 65."
What possible adversities may patients experience when using the SAM Ultrasound Device and Diclofenac Patch?
"Taking into account the fact that this is merely a Phase 2 trial, our team has assigned SAM Ultrasound Device and Diclofenac Patch with a score of two in terms of safety. This indicates there are some available data points on its security but no evidence to support its efficacy."
To what extent has recruitment been successful for this research project?
"Affirmative. According to clinicaltrials.gov, the trial that was posted on June 3rd 2022 is presently recruiting participants. 120 persons will need to be enrolled from three different sites for this study."
Do I meet the criteria for enrollment in this clinical trial?
"To be a part of this study, patients must have arthritis and fall between the ages of 35 and 80. The recruitment process is seeking to enrol approximately 120 participants."
Are there currently any vacancies to partake in this medical experimentation?
"As reported on clinicaltrials.gov, this examination is actively seeking enrolment and has been available since June 3rd 2022 with the most recent update occurring on May 20th 2023."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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