Osteoarthritis Ankle, Osteoarthritis Foot
Conditions
Keywords
Electromagnetic Transduction Therapy
Brief summary
The purpose of this study is to determine if Electromagnetic Transduction Therapy (EMTT) is a viable treatment option in patients with osteoarthritis of the foot and/or ankle.
Interventions
Subjects will be treated with Electromagnetic Transduction Therapy (EMTT) using the Curamedix MAGNETOLITH device. Treatments will be administered twice per week, for four weeks. Each treatment will have the following settings: level 8, 8Hz, and 10,000 pulses andwill take about 15 to 20 minutes. Treatments will be spaced 2-3 days apart.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs.
Exclusion criteria
• Pacemaker, active cancer, shrapnel, metal in eye, implantable devices that are not compatible with MRIs, concurrent foot or ankle condition or injury, prior foot or ankle surgery for osteoarthritis, steroid, platelet rich plasma, or hyaluronic acid injection within 2 months of the treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | Baseline, 3 weeks, 3 months, 6 months | The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. |
| Foot and Ankle Ability Measure (FAAM) | Baseline, 3 weeks, 3 months, 6 months | The Foot and Ankle Ability Measure (FAAM) ADL is a 21-item self-report questionnaire measuring Activities of Daily Living. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 are reported in percentage scores. Higher scores represent higher levels of function, with 100% representing no dysfunction. |
Countries
United States
Outcome results
None listed