Pilot Trial of Steroid Injection for Shoulder Pain (RCT2), Version 1

• Research type

  Research Study

• Full title

  A Single-Blind Randomised Controlled Pilot trial of Corticosteroid Injection for Shoulder Pain

• IRAS ID

  94635

• Contact name

  Tim Holt

• Sponsor organisation

  University of Oxford

• Eudract number

  2012-000147-27

• ISRCTN Number

  na

• Research summary

  Painful shoulders are a common problem frequently seen in general practice, and a widely used treatment is an injection of a steroid and local anaesthetic. However, whilst people often seem to benefit from such injections, it is not known for certain whether the steroid itself is actually affective. To be able to answer this definitively a large scale clinical trial is required. However to ensure the success and reliability of such a study and its results we plan to conduct a pilot trial using a small number of participants to identify any feasibility issues that may be encountered. We will recruit participants presenting to their GPs with shoulder pain. Eligible participants will be randomised to receive an injection of the steroid methylprednisolone plus a local anaesthetic (lidocaine) to their shoulder, or just local anaesthetic alone. Both of these medications are currently used for the treatment of shoulder pain. Over a period of three months participants will complete three Oxford Shoulder Score questionnaires, a tool frequently used by clinicians to assess shoulder symptoms. They will also be asked to answer three ??satisfaction?? questions and to report any unexpected effects, good or bad, during the period of their trial participation. This pilot study will be conducted within the Oxfordshire region and will help us to plan and design a larger trial that will take place over a much wider region with a larger number of participants to determine the efficacy of steroid injections in the treatment of shoulder pain. This study is funded by the NIHR School of Primary Care Research.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  12/SC/0233

• Date of REC Opinion

  30 May 2012

• REC opinion

  Further Information Favourable Opinion