We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03254602
Recruitment Status : Completed
First Posted : August 18, 2017
Results First Posted : November 17, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Plantar Fasciitis, Chronic Device: Intense Therapeutic Ultrasound Treatment

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 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis Musculoskeletal Pain Reduction
Actual Study Start Date : August 4, 2016
Primary Completion Date : April 10, 2017
Study Completion Date : April 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intense Therapeutic Ultrasound Treatment
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.
Device: Intense Therapeutic Ultrasound Treatment
Other Names:
  • Guided Therapy Systems, Ardent Sound, GTS, ITU
  • Actisound


Outcome Measures

Primary Outcome Measures :
  1. Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction [ Time Frame: At 12 weeks after the first treatment ]
    Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.


Secondary Outcome Measures :
  1. Ultrasound Changes [ Time Frame: At 12 Weeks after the first treatment ]
    Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments

  2. Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline [ Time Frame: At 12 Weeks after the first treatment ]
    Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254602


Sponsors and Collaborators
University Foot and Ankle Institute
Guided Therapy Systems
Investigators
Principal Investigator: Bob Baravarian, DPM University Foot and Ankle Institute
  Study Documents (Full-Text)

Documents provided by University Foot and Ankle Institute:
Informed Consent Form  [PDF] August 14, 2017
Study Protocol  [PDF] August 16, 2017
Statistical Analysis Plan  [PDF] August 16, 2017

More Information

Publications:
Responsible Party: University Foot and Ankle Institute
ClinicalTrials.gov Identifier: NCT03254602     History of Changes
Other Study ID Numbers: 20160753
First Posted: August 18, 2017    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: December 7, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases