Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis (ITU)

University Foot and Ankle Foundation

Status: Completed

Conditions: Plantar Fasciitis, Chronic

Treatments: Device: Intense Therapeutic Ultrasound Treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03254602

20160753

Details and patient eligibility

About

A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction began in August 2016 and was completed in April 2017. The clinical setting: University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal study for chronic plantar fasciitis.

Full 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 coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction.

Enrollment: 33 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.
• Age: 18 - 85, depending on the study.
• Unilateral Pain
• Willingness to complete treatment and post treatment regimen as described.
• Patients who have provided written and verbal informed consent.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Intense Therapeutic Ultrasound Treatment

Experimental group

Description:

Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.

Treatment:

Device: Intense Therapeutic Ultrasound Treatment