Status:
COMPLETED
Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction
Lead Sponsor:
Guided Therapy Systems
Collaborating Sponsors:
University of Arizona
Conditions:
Chronic Plantar Fasciitis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Double-blinded feasibility study for the treatment of pain related to chronic plantar fasciitis. A total 37 patients (27 treated and 12 control/sham treated) received 2 treatments, 2 weeks apart on su...
Detailed Description
Intense therapeutic ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coa...
Eligibility Criteria
Inclusion
- • Chronic Pain (\>90 days) from previously diagnosed Plantar Fasciitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
- No History of surgery to the affected anatomy.
- No alternative treatment procedures within the last 90 days.
- Unilateral Pain
- Willingness to complete treatment and post treatment regimen as described.
- Patients who have provided written and verbal informed consent
Exclusion
- • Patients currently enrolled in any other non-conservative, device, or Investigational New Drug clinical trial, or who have participated in a clinical study involving the Plantar Fascia, thirty days prior to study initiation;
- Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
- Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
- At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
Key Trial Info
Start Date :
October 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03255655
Start Date
October 22 2014
End Date
March 1 2016
Last Update
December 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Univesity of Arizona; Orthopaedic Surgery and Biomedical Engineering
Tucson, Arizona, United States, 85724