One hundred thirty-five patients (n=135) participated in and completed the study (Figure 1) which followed the Consolidated Standards of Reporting Trials (CONSORT) [26 (link)]. The study was conducted at Yale-New Haven Health System and Sport and Orthopaedic Physical Therapy (Connecticut, United States of America). The study was performed in accordance with the principles stated in the Declaration of Helsinki. Ethics approval for the study and data collection was obtained from Advarra IRB #0000097. The study followed the International Compilation of Human Research Standards 2018 Edition for the protection of human subjects. The registered study started in September 2020 and was completed in February 2022 (Clinical trial: NCT05254470) (Figure 1).
The inclusion criteria for the study were patients 18 years of age or older undergoing physical therapy for musculoskeletal injury including acute conditions (surgery, sprains, and bone fractures) and chronic conditions (tendinopathy, arthritis, plantar fasciitis), and failed to respond with pain reduction to physical therapy for a minimum of 4 weeks. Patients were excluded if they were not willing to follow the daily treatment protocol, had a known neuropathy, were type 1 or type 2 diabetic, had a cortisone injection into the treatment site in the last 6 months, had a malignancy in the treatment area, had an open wound or had other contraindicated conditions to long duration ultrasound and diclofenac sonophoresis.
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