Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice.

OBJECTIVES: The United Kingdom Frozen Shoulder Trial (UK FROST) compares stand-alone physiotherapy and two operative procedures, both with post operative rehabilitation, for primary frozen shoulder in secondary care. We developed physiotherapy protocols for UK FROST, incorporating best evidence but recognizing uncertainty and allowing flexibility. METHODS: We screened a UK Department of Health systematic review and UK evidence-based guidelines (Hanchard et al., 2012; Maund et al., 2012) for recommendations, and previous surveys of UK physiotherapists (Hanchard et al., 2011, 2013) for strong consensus. We conducted a two-stage, questionnaire-based, modified Delphi survey of shoulder specialist physiotherapists in the UK National Health Service. This required positive, negative or neutral ratings of possible interventions in four clinical contexts (stand-alone physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder; and post operative physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder). We proposed respectively mandating or recommending interventions with 100% and 90% positive consensus, and respectively disallowing or discouraging interventions with 90% and 80% negative consensus. Other interventions would be optional. RESULTS: The systematic review and guideline recommended including steroid injection and manual mobilizations in non-operative care, and we mandated these for stand-alone physiotherapy. Consensus in the pre-existing surveys strongly favoured advice, education and home exercises, which we mandated across contexts. The Delphi survey led to recommendation of some supervised exercise modalities, plus the disallowing or discouragement-in various contexts-of immobilization and some 'higher-tech' electrotherapies and alternative therapies. CONCLUSIONS: We developed physiotherapy protocols despite incomplete empirical evidence. Their clear structure enabled implementation in data-sheets designed to facilitate recording, monitoring of fidelity and reporting of interventions. Other trials involving physiotherapy may benefit from this approach.

Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial.

OBJECTIVES: A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. METHODS: These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. RESULTS: All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. CONCLUSION: In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335-40.

Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.

BACKGROUND: Acute anterior dislocation is the commonest type of shoulder dislocation and usually results from an injury. Subsequently, the shoulder is less stable and more susceptible to redislocation, especially in active young adults. OBJECTIVES: To compare methods of conservative (non-surgical) management versus no treatment or different methods of conservative management after closed reduction of traumatic anterior dislocation of the shoulder. Interventions include methods of postreduction immobilisation and rehabilitation. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE, EMBASE, the National Research Register (UK), conference proceedings and reference lists of articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing various conservative interventions versus control (no or sham treatment) or other conservative interventions applied after closed reduction of traumatic anterior dislocation of the shoulder. DATA COLLECTION AND ANALYSIS: All authors selected trials, assessed methodological quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: One flawed quasi-randomised trial was included. A "preliminary report" gave the results for 40 adults with primary traumatic anterior dislocation of the shoulder treated by post-reduction immobilisation with the arm in either external or internal rotation. There was no statistically significant difference between the two groups in the failure to return to pre-injury sports by previously active athletes, in redislocation or shoulder instability. Similar numbers of participants of the two groups removed their immobiliser before one week had passed. AUTHORS' CONCLUSIONS: There is a lack of evidence from randomised controlled trials to inform the choices for conservative management following closed reduction of traumatic anterior dislocation of the shoulder. Sufficiently powered, good quality, well reported randomised controlled trials with long-term surveillance of conservative management are required. In particular, trials examining the type and duration of immobilisation would be useful.