Musculoskeletal treatments using intense therapy ultrasound: Clinical studies for chronic plantar fasciitis and lateral epicondylitis

Background/Objective: Intense Therapy Ultrasound (ITU) effectively creates thermal injury zones inside soft tissue, initiating a tissue repair cascade in the skin, promoting collagen generation. It may be feasible to promote a robust healing response in musculoskeletal tissue accelerating healing from injury [1]. The objectives of the studies were to establish the feasibility of treatment by High Frequency ITU for Plantar Fasciitis and Lateral Epicondylitis. Protocols/Methods: Chronic Plantar Fasciitis: Two treatments, 2 weeks apart, 38 patients, (27-treated, 11-sham group) consisted of 250-320 80 msec pulses creating matrices of small ablative thermal lesions of 4-5 joules at a pre-programmed pitch of 1.6 mm. Each treatment did not exceed 12 minutes. Treatment effects were assessed with diagnostic ultrasound imaging at 12 MHz. Ultrasound images were analyzed to determine changes in peri-fascial lesion size. Patients reported outcomes at 2, 4 6 and 12 weeks after initiating treatment [2]. Chronic Lateral Epicondylitis: Two treatments, 4 weeks apart, 24 patients, consisting of 80 14 msec pulses creating matrices of small ablative thermal lesions of 1 joule. Manually targeted area mapped by diagnostic ultrasound imaging. Each treatment was less than 10 minutes. Treatment effects were assessed with diagnostic ultrasound at 17MHz. Patient reported outcomes at 2, 4, 8 and 12 weeks after initial treatment. For both studies patients randomized, the principal investigator, sonographer and study coordinator administering the study were blinded to clinical assessments and diagnostic ultrasound results. Results/Conclusions: Plantar Fasciitis: Results of the double blinded, randomized, sham controlled study for the treatment of Plantar Fasciitis with ITU appeared to have significant positive results within 12 weeks' post-treatment in 81% of patients treated. Both quantitative measurements from diagnostic ultrasound imaging and applied standardized assessment protocols showed statistically significant coincidental improvements in treated patients vs. control group. Chronic Lateral Epicondylitis: Statistically significant improvements were seen in 75% of patients and diagnostic ultrasound images show significant reduction in free fluid at 8 weeks compared to baseline images in patients with no to mild peri-tendon calcifications. These patients correlated well with significantly improved PRTEE survey scores. Few patients with little or no improvement in PRTEE scores consistently presented with moderate to severe peri-tendon calcifications.