Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Plantar Fasciitis

In brief

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 subcutaneous plantar fascia musculoskeletal tissue along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.

Key facts

Study ID

NCT03255655

Run by

Guided Therapy Systems

People needed

41

Starts

2014-10-22

Expected to finish

2016-03-01

Last updated by the study team

2017-12-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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.

Where it is running

• The Univesity of Arizona; Orthopaedic Surgery and Biomedical Engineering — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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