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Focused shockwave treatment for greater trochanteric pain syndrome: a multicenter, randomized, controlled clinical trial
Ramon S, Russo S, Santoboni F, Lucenteforte G, di Luise C, de Unzurrunzaga R, Vetrano M, Albano M, Baldini R, Cugat R, Stella G, Balato G, Seijas R, Nusca SM, Servodidio V, Vulpiani MC
Journal of Bone and Joint Surgery -- American Volume 2020 Jun 10:Epub ahead of print
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Greater trochanteric pain syndrome (GTPS) is a condition of lateral hip pain. Its physiopathology remains unknown, and there is no consensus on optimal management. The aim of this study was to assess the effectiveness of electromagnetic-focused extracorporeal shockwave treatment (F-ESWT) in patients with GTPS. METHODS: This multicenter clinical trial included 103 patients with chronic GTPS randomly assigned to the treatment group, consisting of electromagnetic F-ESWT and a specific exercise protocol, or the control group, receiving sham F-ESWT and the same exercise protocol. Both groups were treated with 3 weekly sessions; the F-ESWT group received an energy flux density of 0.20 mJ/mm, whereas the control group received 0.01 mJ/mm. Patients were assessed at baseline and 1, 2, 3, and 6 months after treatment. A visual analogue scale (VAS) score for pain at 2 months was the primary outcome. The Harris hip score (HHS), Lower Extremity Functional Scale (LEFS), EuroQoL-5 Dimensions Questionnaire (EQ-5D), and Roles and Maudsley score were used as secondary outcomes. Complications were recorded. RESULTS: The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001). All secondary outcomes at all follow-up intervals were significantly better in the F-ESWT group, except for the LEFS score at 1 month after treatment (p = 0.25). No complications were observed. CONCLUSIONS: F-ESWT in association with a specific exercise program is safe and effective for GTPS, with a success rate of 86.8% at 2 months after treatment, which was maintained until the end of follow-up. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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