Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction
Condition: Chronic Plantar Fasciitis
MeSH terms: Musculoskeletal Pain; Fasciitis; Fasciitis, Plantar
Study type: Interventional

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.
    

Intervention name(s): Intense Therapeutic Ultrasound Treatment - ITU
Intervention type(s): Device
Other intervention name(s): Guided Therapy Systems, Ardent Sound, GTS, ITU
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)
Primary purpose: Treatment
Keywords: Chronic Plantar Fasciitis; Plantar Fascia Pain; Intense Therapeutic Ultrasound (ITU); Guided Therapy Systems (GTS); Ardent Sound, Inc.; Actisound