Clinical trial NCT03255655: Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction
Official title: Intense Therapeutic Ultrasound for Chronic Plantar Fascia Musculoskeletal Pain Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Plantar Fasciitis
Keywords: Chronic Plantar Fasciitis
Plantar Fascia Pain
Intense Therapeutic Ultrasound (ITU)
Guided Therapy Systems (GTS)
Ardent Sound, Inc.
Actisound
Lead sponsor: Guided Therapy Systems
Sponsor class: INDUSTRY
Collaborators: name: University of Arizona
First posted: 2017-08-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Average Percentage of Change as Reported Using Foot Function Index Pain Subscale
timeFrame: 12 weeks after 1st Treatment
measure: Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging
timeFrame: 12 Weeks after the first Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The Univesity of Arizona; Orthopaedic Surgery and Biomedical Engineering
state: Arizona
Study officials:
affiliation: University of Arizona; Orthopaedic Surgery and Biomedical Engineering; Department of Orthopaedic Surgery
name: Dan Latt, Md, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1001/archfaci.9.1.22.
citation: 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.
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. doi: 10.1001/archfaci.9.2.88.
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.
citation: 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.
citation: DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.