Extracorporeal shockwave therapy with a modified peppering technique for knee osteoarthritis: study protocol for a randomized controlled trial

Abstract

Background and objectives: Extracorporeal shockwave therapy (ESWT) has been shown to promote pain relief and functional improvement in osteoarthritis (OA) patients. We aimed to determine the efficacy of ESWT for knee OA with a modified peppering technique by comparison with sham treatment. Design: A single-center, double-blinded, randomized controlled trial. Methods: This trial will be performed at Taoyuan General Hospital, Taiwan, China. We will enroll at least 36 patients with knee OA (Kellgren-Lawrence grading scale, grade 2 to grade 4) to receive ESWT or sham ESWT. Using simple randomization patients will be assigned into two groups: ESWT and sham ESWT. In the ESWT group, patients will receive 1600 pulses of shockwave at 0.24 mJ/mm2 weekly for 3 weeks. In the sham ESWT group, patients will receive 1600 pulses of shockwave at 0.24 mJ/mm2 in the same area without jelly between applicator pad and handpiece. Outcome measures: The primary outcome measure is Western Ontario and McMaster Universities Osteoarthritis Index. The secondary outcome measures are Visual analog scale and six-minute walk test. The patients will be evaluated at baseline, 3rd week and 4th week. Discussion: The trial outcomes will investigate the effects of ESWT with a modified peppering technique in patients diagnosed with knee OA. Ethics and dissemination: This study protocol has acquired written approval from Ethics Committee, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan, China (IRB No. TYGH105013), and will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association. Written informed consent will be obtained from all participants. The results will be published in peer-reviewed journals or disseminated via conference presentations. Trial registration: ClinicalTrial.gov identifier: NCT03048773; registered on February 9, 2017. Protocol version: 1.0.