Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis

Plantar Fasciitis, Chronic Clinical Trial

— ITU  

Official title:

Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis Musculoskeletal Pain Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254602
• Other study ID #: 20160753
• Status: Completed
• Phase: N/A
• First received: August 14, 2017
• Last updated: November 14, 2017
• Start date: August 4, 2016
• Est. completion date: April 10, 2017

Study information

• Verified date: October 2017
• Source: University Foot and Ankle Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis, Chronic

Intervention

Device:
• Intense Therapeutic Ultrasound Treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Foot and Ankle Institute	Guided Therapy Systems

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ultrasound Changes	Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments	At 12 Weeks after the first treatment
Secondary	Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline	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) p x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)	At 12 Weeks after the first treatment