Evaluating the efficacy of High-energy Extracorporeal Shockwave Therapy Aimed at Treating Calcified Shoulder (ESWT-CS): a study protocol for a randomized controlled trial

Abstract

Shockwave therapy is a solid scientifically based medical tool used to manage calcified shoulder. This therapy, along with its pros and cons, is paving its way among armamentarium of interventions for musculoskeletal disorders. Objective: To determine efficacy of extracorporeal shockwave therapy on subjective and objective measures in patients with calcified shoulder. Methods: Single-blinded, parallel-group, randomized trial will be conducted on sample of 48 participants recruited through convenient sampling. Patients with calcified shoulder tendinopathy, aged between 30-55 years and both gender will be included. Outcome measures will be numeric pain rating scale, Constant and Murley score, Western Ontario rotator cuff index, shoulder ROM and radiological outcomes. Current study has been initiated in June 2020 till enrollment in December 2020.The quantitative data would present in the form of mean and standard deviation. After fulfilling the parametric assumptions, data will be analyzed using independent sample t-test/Mann Whitney test. Repeated measure ANOVA/Friedman test for pair-wise comparisons for follow-ups will be used to determine the effects of treatment within the groups at baseline, in 6th week and 12th week after commencement of treatment. Discussion: Evidence reported related to shockwave therapy for tendinopathy shows less quality and less number of randomized trials done, with no comparable groups and methodological deficiencies of studies. Trial registration: Approval was obtained from Institutional Review Board Committee (ref: IRB-UOL-FAHS/693/2020). The study was registered on 28th March 2020 in Iranian Registry of Clinical trials (IRCT), its registration reference number is IRCT20200204046373N1 https://irct.ir/trial/45657.