steroid injection vs steroid injection and hydrodilatation

  • Research type

    Research Study

  • Full title

    Study to compare the effects of steroid injection vs steroid injection and hydrodilatation in the treatment of adhesive capsulitis

  • IRAS ID

    148661

  • Contact name

    Carlos Cobiella

  • Contact email

    Carlos@Cobiella.com

  • Sponsor organisation

    JRO UCL

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    This study aims to compare the effectiveness of two common treatments for frozen shoulder (adhesive capsulitis) currently used in University College London Hospital (UCLH).
    Frozen shoulder is a very common issue affecting 3 in 100 people. The Condition occurs due to inflammation in the lining of the shoulder joint (capsule), causes the lining to become scarred, sticking to the bone and restricting shoulder movement and incurring pain. Sufferers normally experience these symptoms for 18-24 months.
    The condition is often self-resolving and treatments are generally geared to managing the signs and symptoms in this time. Two treatments, UCLH offers for this are Hydrodilatation and Steroid injection. Steroid injection comprises direct injection a of a steroid into the lining of the shoulder, while Hydrodilatation is where saline is used to balloon out the lining that has become restrictive, and it also is combined with a steroid to help reduce the inflammation. There is limited comparative evidence as to which treatment, if any, has the greater patient benefit. This study aims to address that knowledge gap, which can subsequently inform practitioners for future best care for patients.
    The aim of the study is to compare the effectiveness of each treatment through assessment of randomized groups of patients receiving each treatment.
    Patients will be assessed prior to intervention and subsequently 6 weeks and 3 months post intervention. Initial assessment will include capture of relevant background information and prior treatment history and all assessment will include questionnaires and a measure of strength and range of motion in the affected shoulder.
    The Study will take place at UCLH and is only eligible to patients suffering with frozen shoulder who are able to give informed consent. All patients presenting with frozen shoulder should be considered for the trial, but it’s the clinician’s choice if they wish to offer other treatments.

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    15/SC/0124

  • Date of REC Opinion

    13 Mar 2015

  • REC opinion

    Further Information Favourable Opinion