Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis

NCT03254602 | Completed Results FDA Device

• 1 other identifier: 20160753
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plantar Fasciitis, Chronic

Outcome Measures

Primary Outcomes (1)

• Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction

  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.

  At 12 weeks after the first treatment

Secondary Outcomes (2)

• Ultrasound Changes

  At 12 Weeks after the first treatment

• Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline

  At 12 Weeks after the first treatment

Study Arms (1)

Intense Therapeutic Ultrasound Treatment

EXPERIMENTAL

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

Interventions

Intense Therapeutic Ultrasound Treatment DEVICE

Also known as: Guided Therapy Systems, Ardent Sound, GTS, ITU, Actisound

Intense Therapeutic Ultrasound Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

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.

Sponsors & Collaborators

• University Foot and Ankle Foundation: lead
• Guided Therapy Systems: collaborator

Related Publications (6)

• White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.

  PMID: 17224484 BACKGROUND

• Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.

  PMID: 20115948 BACKGROUND

• Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.

  PMID: 17372061 BACKGROUND

• Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.

  PMID: 18429926 BACKGROUND

• Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.

  PMID: 12696985 BACKGROUND

• Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305.

  PMID: 16801514 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Limitations and Caveats

Bias was mitigated as much as possible within the protocol by way of the blinding throughout the layers of patients and personnel involved in the study.

Results Point of Contact

• Title: Rich Amodei, RDMS
• Organization: Guided Therapy Systems

r.amodei@guidedtherapy.com

480-649-8587

Study Officials

• Bob Baravarian, DPM

  University Foot and Ankle Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 18, 2017
• Study Start: August 4, 2016
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: December 7, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share