Administrative information
Title {1} | A comparison of different physical stimulation combined with Platelet-rich plasma for the treatment of knee osteoarthritis: study protocol for a randomized controlled trial |
Trial registration {2a and 2b}. | This study has been registered with the Chinese Clinical Trials Registry. Registration number: ChiCTR2200065119 |
Protocol version {3} | Issue date: 25 October 2022 Protocol amendment number: 02 |
Funding {4} | This study is unfunded, but the platelet-rich plasma preparation kit will be supplied by WEGO (WEGO, Weihai, China). LIFU and TENS instruments will be supplied by Taiyou (Taiyou, Chengdu, China). |
Author details {5a} | Rehabilitation Medicine Centre, West China Hospital, Sichuan University, School of Rehabilitation Sciences, West China School of Medicine, Sichuan University, Rehabilitation Medicine Key Laboratory of Sichuan Province, Chengdu, Sichuan, PR China |
Name and contact information for the trial sponsor {5b} | Contact name: Mrs. Song-Chun Chen and Mrs. Shi-Ming Liu. Email: xshscb@weigaogroup.com, admin@taiyoumed.com |
Role of sponsor {5c} | This sponsor source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
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Diagnosis of osteoarthritis using the American College of Rheumatology criteria
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Radiological grading of Grade I–III osteoarthritis (OA) of the knee using the Kellgren and Lawrence system
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Previous internal and external fixation brackets after joint surgery
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The patients with local skin ulceration, infection, or local skin sensory disturbance
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The patients have used anti-inflammatory drugs in the past 2 weeks and non-steroidal anti-inflammatory drugs in the past 2 days
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The patients combined with language listening and speaking impairment or unable to cooperate with the doctor’s treatment
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The patients with a pacemaker
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The patients with blood system diseases