Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01993693
Eligibility Criteria:
Individual will be included if they:
1. Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months,
2. are between 35-65 years of age
3. report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
4. report mobility limitations because of their knee pain
5. are currently not taking any prescription pain medication other than nonsteroidal antiinflammatory drugs (NSAIDs). All pain medication taken during the study should be documented.
6. are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
7. are deemed appropriate by their physician to participate.
Individuals will be excluded if they:
1. cannot successfully demonstrate the ability to put on and take off the device
2. are cognitively impaired
3. have bone-on-bone crepitus
4. have severe OA or patients with little to no cartilage on the knee
5. have knee replacement or other surgical intervention
6. take variable prescription medication
7. are non-ambulatory
8. participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
9. are currently taking neuropathic medications (ie: Neurontin, Lyrica or Topamax) and/or antidepressants (ie: Amitriptyline).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT01993693
Study Brief:
Protocol Section:
NCT01993693