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

November 15, 2017 updated by: Guided Therapy Systems

Intense Therapeutic Ultrasound for Chronic Plantar Fascia Musculoskeletal Pain Reduction

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide have been treated using this technology. Clinical studies have shown that 85% of patients receiving this treatment on facial skin tissue showed an improvement in facial lifting with no significant pain, erythema, inflammation or scarring by creating the same coagulative changes to the connective tissue under the skin. Histologically, it has been shown that ITU induces the production of dermal collagen with thickening of the dermis and straightening of the elastic fibers in the reticular dermis.

On-going research in laboratory studies has shown that ITU can improve healing of damaged Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta 1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated with ITU compared to injured, untreated rabbit tendons.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • The Univesity of Arizona; Orthopaedic Surgery and Biomedical Engineering

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ITU Treatment
Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.
Device: Intense Therapeutic Ultrasound Treatment - ITU
Other Names:
  • Guided Therapy Systems, Ardent Sound, GTS, ITU
PLACEBO_COMPARATOR: Sham ITU Treatment
Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.
Device: Intense Therapeutic Ultrasound Treatment - ITU
Other Names:
  • Guided Therapy Systems, Ardent Sound, GTS, ITU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Percentage of Change as Reported Using Foot Function Index Pain Subscale
Time Frame: 12 weeks after 1st Treatment
Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.
12 weeks after 1st Treatment
Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging
Time Frame: 12 Weeks after the first Treatment
Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).
12 Weeks after the first Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guided Therapy Systems

Collaborators

University of Arizona

Investigators

  • Principal Investigator: Dan Latt, Md, Ph.D., University of Arizona; Orthopaedic Surgery and Biomedical Engineering; Department of Orthopaedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 22, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (ACTUAL)

August 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTS - ITU UA Plantar Fascia 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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