ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction
Condition: Tennis Elbow
MeSH terms: Musculoskeletal Pain; Tennis Elbow
Study type: Interventional

Summary: 
      This study evaluates the effectiveness, safety and patient tolerance for the use of Intense
      Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal
      tissue pain reduction began in July 2015 and was completed in March 2017. The More
      Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic
      lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on
      subcutaneous musculoskeletal tissues 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
Intervention type(s): Device
Other intervention name(s): Guided Therapy Systems, Ardent Sound, GTS, ITU; Actisound
Intervention model: Single Group Assignment
Intervention model description: Patients age 18 - 85, previously diagnosed with Chronic Lateral Epicondylitis, with symptoms exceeding 90 days, and where Standard of Care treatments have failed to resolve the symptoms.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Lateral Epicondylitis; Tennis Elbow; Intense Therapeutic Ultrasound (ITU); Guided Therapy Systems (GTS); Ardent Sound, Inc.; Actisound