Focused Shockwave (ESWT), Radial Pressure Waves (EPAT), And Electromagnetic Transduction Therapy (EMTT) For Lower Extremity Musculoskeletal Injuries
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Men and women > 18 with lower extremity musculoskeletal injury confirmed by physician
Exclusion Criteria:
- All devices: Patients with active cancer or who may be pregnant.
- For EMTT only, patients with shrapnel, metal in the body, pacemaker, or non-MRI compatible implantable devices.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: shock wave only
|
shockwave
|
|
Experimental: shock wave + radial pressure wave
|
shockwave
Pressure waves
|
|
Experimental: EMTT
|
EMTT
|
|
Experimental: shock wave + EMTT
|
shockwave
EMTT
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
VAS
Time Frame: initial, 6weeks, 3 months, 6 months, 1 year
|
initial, 6weeks, 3 months, 6 months, 1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FAAM
Time Frame: baseline, 6 week, 3 month, 6 month 1 year
|
baseline, 6 week, 3 month, 6 month 1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Elizabeth Bondi, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 25-011219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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