Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial

Abstract

Background Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection. MethodsIn this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508.

Midterm Outcomes After Arthroscopic Coracoid Decompression Combined With Manipulation for the Treatment of Frozen Shoulder Associated With Subcoracoid Impingement

“…MUA is often used to treat FS when conservative treatments have failed. MUA can provide improvement of shoulder function [30,31]. However, sometimes MUA is subject to great resistance because of joint adhesion, and aggressive manipulation may result in iatrogenic lesions, including hemarthrosis, superior labral anterior and posterior lesions, rotator cuff tears, and humeral or glenoid fractures.…”

Clinical Guidelines in the Management of Frozen Shoulder: An Update!

“…According to ISAKOS guidelines; if the range of movement is less than 100° in forward flexion, less than 10° in external rotation, and less than L5 vertebral level in internal rotation, it is defined as a global restriction of ROM [1]. In a recently published FROST trial, investigators defined FS as a condition characterised by the restriction of passive external rotation in the affected shoulder to less than 50% of the opposite shoulder with normal radiographs [28]. The strength of the rotator cuff is relatively unaffected.…”

“…2. Arthroscopic capsular release: Although all high-quality clinical studies have failed to reveal any major advantage of ACR over MUA [28,97]; of late, ACR has emerged as 'preferred' surgical option for the treatment of refractory FS as ACR allows controlled and precise release of fibrosed capsule-ligament complex under vision avoiding the said complications of MUA under the same anaesthetic burden [41,95]. Further, ACR enables the surgeon to thoroughly inspect and treat a "clinically or [42] No difference Jenkins et al, 2012 [91] 36% of diabetics may require repeat MUA compared to 15% controls Woods et al, 2017 [92] 38% risk of repeat MUA in diabetics compared to 18% as a group radiologically missed" concomitant lesion of the cartilage, rotator cuff, labrum and subacromial space, if any, which may be contributing to the pathology.…”

“…The PT program should consist of early passive and active-assisted ROM along with scapula stabilisation followed by active ROM combined with strengthening exercises for rotator cuff, scapular muscles, and core rehabilitation. 4 Arthroscopic view (from anterior portal) of inflamed synovium-capsule over the infraspinatus MUA vs. ACR: Despite all said advantages of ACR over MUA, literature has failed to prove clinical superiority of ACR over MUA [28,83,97]. A recently published triple arm pragmatic superiority randomised controlled trial by Rangan et al concluded that PT, MUA and ACR are not superior to each other in treatment of resistant FS [28].…”

“…4 Arthroscopic view (from anterior portal) of inflamed synovium-capsule over the infraspinatus MUA vs. ACR: Despite all said advantages of ACR over MUA, literature has failed to prove clinical superiority of ACR over MUA [28,83,97]. A recently published triple arm pragmatic superiority randomised controlled trial by Rangan et al concluded that PT, MUA and ACR are not superior to each other in treatment of resistant FS [28]. Further, Rangan et al concluded that ACR is more costly and associated with serious adverse events (4%) while MUA is most costeffective procedure [28].…”