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

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ClinicalTrials.gov Identifier: NCT03255655
Recruitment Status : Completed
First Posted : August 21, 2017
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Guided Therapy Systems

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 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.

Condition or disease Intervention/treatment Phase
Chronic Plantar Fasciitis Device: Intense Therapeutic Ultrasound Treatment - ITU Not Applicable

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  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Adult Patients (age 18 - 85) of either gender diagnosed with chronic plantar fasciitis pain (>90 days) where Standard of Care treatments had failed to reduce pain.
Masking: Single (Investigator)
Masking Description:

Investigator was blinded to the treated vs. control/sham treated patient identity and to the treated foot.

Researchers were blinded to the Investigators physical exam finding and patient outcome measure reports

Primary Purpose: Treatment
Official Title: Intense Therapeutic Ultrasound for Chronic Plantar Fascia Musculoskeletal Pain Reduction
Actual Study Start Date : October 22, 2014
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : March 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: Guided Therapy Systems, Ardent Sound, GTS, ITU




Primary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
    • 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.

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): NCT03255655


Locations
United States, Arizona
The Univesity of Arizona; Orthopaedic Surgery and Biomedical Engineering
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Guided Therapy Systems
University of Arizona
Investigators
Principal Investigator: Dan Latt, Md, Ph.D. University of Arizona; Orthopaedic Surgery and Biomedical Engineering; Department of Orthopaedic Surgery
  Study Documents (Full-Text)

Documents provided by Guided Therapy Systems:
Study Protocol  [PDF] April 5, 2014
Informed Consent Form  [PDF] May 23, 2014
Statistical Analysis Plan  [PDF] May 23, 2014


Publications:
Responsible Party: Guided Therapy Systems
ClinicalTrials.gov Identifier: NCT03255655     History of Changes
Other Study ID Numbers: GTS - ITU UA Plantar Fascia 01
First Posted: August 21, 2017    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 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

Keywords provided by Guided Therapy Systems:
Chronic Plantar Fasciitis
Plantar Fascia Pain
Intense Therapeutic Ultrasound (ITU)
Guided Therapy Systems (GTS)
Ardent Sound, Inc.
Actisound

Additional relevant MeSH terms:
Musculoskeletal Pain
Fasciitis
Fasciitis, Plantar
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Foot Diseases