United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial

Abstract

BackgroundFrozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy.MethodsWe will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods.DiscussionThe three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults.Trial registrationInternational Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2352-2) contains supplementary material, which is available to authorized users.

Muscle stiffness, gait instability, and liver cirrhosis in Wilson's disease

“…Further details about the delivery, type, and dose of the steroid are provided in the appendix (p 2). 16 2). Mean estimates were less than the minimal clinically important effect size of 4-5 OSS points (table 3).…”

“…current evidence did not support the superiority of either approach. 21 Full details about the physiotherapy programmes are given elsewhere, 12,16 and included information on pain management, mobilisation techniques (increasingly stretching into the stiff part of the range of movement), and a graduated home exercise programme that progressed from gentle pendular exercises to firm stretching exercises according to the stage of frozen shoulder, as is accepted good practice. 11,20 Manipulation under anaesthesia and arthroscopic capsular release were done as day case surgical procedures within 18 weeks of randomisation.…”

Idiopathic frozen shoulder

“…It occurs when the capsule, or the soft tissue envelope, becomes scarred and contracted, making the shoulder tight, painful and stiff. 9…”

“…It is a general belief that frozen shoulder resolves spontaneously after 1-3 years, 9 although there is a paucity of long-term follow up data to support this. 10 symptoms, with 7-15% having some degree of permanent loss of movement.…”

Tissue inflammation signatures point towards resolution in adhesive capsulitis

“…We also investigated if frozen shoulder tissues expressed proresolving receptors mediating resolution of inflammation. The frozen shoulder cohort consisted of 12 female and 4 male patients aged between 43-72 undergoing arthroscopic capsular release surgery as part of the NIHR-HTA programme funded UK FROST study [3]. Frozen shoulder patient tissues were compared with those from similarly aged patients with torn supraspinatus tendons undergoing surgical debridement and repair (n=11).…”