A Single-Blind Randomised Controlled Pilot trial of Corticosteroid Injection for Shoulder Pain - Pilot Trial of Steroid Injection for Shoulder Pain (RCT2), Version 1

niversity of Oxford0 个研究点开始时间: 2012年7月12日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•Male or female, aged 35 to 74 years
•Diagnosed with rotator cuff tendinopathy or adhesive capsulitis by a general practitioner trained in shoulder assessment, with duration of symptoms no greater than 6 months
•Willing to allow his or her usual General Practitioner to be notified of participation in the study and to be contacted for further information if an adverse event related to the trial occurs
•Able to complete follow-up data collection by questionnaire at 2, 4 and 12 weeks
•Willing and able to give informed consent for participation in the trial
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Female participants who are pregnant, lactating or planning pregnancy during the course of the study
•Participants who have participated in another research study involving an investigational product in the past 12 weeks
•Those having already received a shoulder injection in the past 12 months
•Those with other established chronic shoulder disorders (e.g. rheumatoid arthritis, other inflammatory poly-arthropathies and osteroarthritis)
•A history of previous shoulder surgery on the affected side
•Those with evidence of active infection anywhere, including temperature = to or > than 37.5oC
•Those currently prescribed anticoagulants
•Those either currently prescribed or likely to need during the following 12 months, systemic corticosteroids for any reason
•Immunocompromised
•Uncontrolled diabetes or uncontrolled hypertension
•A diagnosis of heart failure
•Those considered unable due to cognitive impairment to reliably report outcome measures
•Any other significant disease or disorder which, in the opinion of the general practitioner, may either put the participants at risk because of participation in the study, or may influence the participant's ability to participate in the study.
•Any patient who is allergic to corticosteroids and/or lidocaine.

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