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• UK FROST

• UK FROST
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UK FROST: United Kingdom Frozen Shoulder Trial 

The UK FROST RCT examined the clinical and cost-effectiveness of three secondary care treatments for adults with frozen shoulder. The trial provided robust evidence that none of the three trial treatments were superior on patient-reported outcomes at 12 months.

Why did we do this research?

For most people frozen shoulder is a self-limiting condition of approximately one to three years duration. It happens when the flexible tissue surrounding the shoulder joint becomes inflamed and thickened, resulting in contraction (tightening) of the tissue and scarring. The shoulder then becomes very tight, painful and stiff which often can be extremely debilitating and interfere with people’s work, home and leisure activities. Most people eventually get better, even without treatment. However, for around one in 10 patients the condition is more resistant and these patients are referred to hospital. Hospital treatment commonly involves physiotherapy or one of two surgical procedures. It was unclear which of these treatments provided the best patient outcomes and was cost-effective.

 What did we do?

In our trial we randomised 503 patients with frozen shoulder to receive early physiotherapy, or manipulation under anaesthesia or arthroscopic capsular release. Patient experiences of all three interventions were examined to give important patient-centred insight to further guide clinical decision making. We followed patients up for 12 months and asked them questions about their functional limitation, symptoms, pain and general health. We also collected information on complications and medical occurrences.

Who was involved?

Patients were recruited from 35 hospital sites in the UK. On average, participants were 54 years old and 63% were female.

What did we find?

The trial provided robust evidence that none of the three trial treatments were superior on patient-reported outcomes at 12 months, although a marginal clinically important benefit of  capsular release may exist over physiotherapy. Early physiotherapy was accessed more quickly than the surgical options and was lower in cost. Manipulation under anaesthesia was found to be the most cost-effective option. Capsular release had higher risks and costs compared with manipulation and physiotherapy, but fewer participants in this group required further treatment.

What have we learned? 

The evidence from UKFROST suggests that capsular release should be used more selectively, when less costly less invasive interventions fail.

Outputs

Publications

• Rangan A, Brealey SD, Keding A, et al. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet. 2020 Oct 3;396(10256):977-989. https://doi.org/10.1016/S0140-6736(20)31965-6
• Brealey S, Northgraves M, Kottam L, et al. Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT. Health Technol Assess. 2020 Dec;24(71):1-162. https://doi.org/10.3310/hta24710 
• Knowlson CN, Brealey S, Keding A, et al. Examination of early treatment effects and related biases during the conduct of two UK-wide pragmatic orthopaedic surgical trials: ProFHER and UK FROST. Bone Jt Open. 2023 Feb 14;4(2):96-103. https://doi.org/10.1302/2633-1462.42.BJO-2022-0139 
• Valsamis EM, Beard D, Carr A, et al. Mapping the Oxford Shoulder Score onto the EQ-5D utility index. Qual Life Res 32, 507–518 (2023). https://doi.org/10.1007/s11136-022-03262-4
• Rex SS, Kottam L, McDaid C, et al. Effectiveness of interventions for the management of primary frozen shoulder : a systematic review of randomized trials. Bone Jt Open. 2021 Sep;2(9):773-784. https://doi.org/10.1302/2633-1462.29.BJO-2021-0060.R1 
• Corbacho B, Brealey S, Keding A, et al. Cost-effectiveness of surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder : an economic evaluation of the UK FROST trial. Bone Jt Open. 2021 Aug;2(8):685-695. https://doi.org/10.1302/2633-1462.28.BJO-2021-0075.R1 
• Srikesavan C, Toye F, Brealey S, et al. Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study. BMJ Open. 2021 Jun 11;11(6):e040829. https://doi.org/10.1136/bmjopen-2020-040829 
• Hanchard NCA, Goodchild L, Brealey SD, et al. 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. Physiotherapy. 2020 Jun;107:150-160. https://doi.org/10.1016/j.physio.2019.07.004 
• Partha Sarathy P, Kottam L, Parker A, et al. Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses. J Clin Epidemiol. 2020 Jun;122:70-77. https://doi.org/10.1016/j.jclinepi.2020.03.001 . 
• Dakin SG, Rangan A, Martinez F, et al. Tissue inflammation signatures point towards resolution in adhesive capsulitis. Rheumatology (Oxford). 2019 Jun 1;58(6):1109-1111. https://doi.org/10.1093/rheumatology/kez007 
• Brealey S, Armstrong AL, Brooksbank A, et al. 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. Trials. 2017 Dec 22;18(1):614. https://doi.org/10.1186/s13063-017-2352-2 . 

Presentations

• A Rangan. UKFROST results: a call to physiotherapists. Manchester. 10th November, 2022. 
• A Rangan. UKFROST Study Results. 2nd Northeast Shoulder & Elbow Symposium hosting the BESS roadshow at Durham Conference Centre, Durham. 1st April 2022.
• A Rangan. UKFROST enhanced dissemination: Physiotherapy pathways. 2nd Northeast Shoulder & Elbow Symposium hosting the BESS roadshow at Durham Conference Centre, Durham. 1st April 2022.
• A Rangan. UKFROST trial results.  European Shoulder & Elbow Society meeting (SECEC / EUSSER): presentation at virtual conference 18th May 2021.
• A Rangan. UKFROST results.  UCL meeting 29th November 2020.
• A Rangan. UKFROST: an example of high quality patient centred research. NIHR CRN NENC virtual meeting themed 'patient centred research'. 9th-14th October 2020.
• A Rangan. The United Kingdom Frozen Shoulder Trial. BOA online Virtual Meeting. 13th-19th September, 2020.
• A Rangan. UK FROST preliminary results. Research meeting of surgeons and AHPs in CoDurham & Tees Valley Treebridge Hotel, Teesside. 27th-29th January 2020. 
• C. Srikesavan, F. Toye, S. Brealey, L. Goodchild, ... A. Rangan. The experiences of participants and healthcare professionals in the United Kingdom Frozen Shoulder Trial (UK FROST): A nested qualitative study.  Virtual Physiotherapy UK 2020 (oral presentation). 13th-14th November 2020.
• A Rangan. The United Kingdom Frozen Shoulder Trial: podium presentation at the International Congress for Shoulder & Elbow Surgery (ICSES), Buenos Aires, 19th September 2019.

Other outputs

• Animations
  • UKFROST Trial Team. Frozen shoulder: which treatment should you choose? YouTube Channel https://youtu.be/I88uzfD8Y4s October 2020
• Featured articles
  • Jackie Mitchell. Frozen Shoulder. In People’s Friend. An article published from an interview with Prof Amar Rangan. 11th September 2021. 
  • Jackie Mitchell. Frozen Shoulder. In Health & Wellbeing. An article published from an interview with Prof Amar Rangan. 11th September 2021. 
  • Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three arm, superiority randomized clinical trial.  Bone & Joint 360. volume 10, issue 1, February 2021.
  • Catherine Knowlson et al. Examination of early treatment effects and related biases during the conduct of two UK-wide pragmatic orthopaedic surgical trials: ProFHER and UK FROST. Bone Jt Open. 2023;4(2):96-103. doi:10.1302/2633-1462.42.BJO-2022-0139
• Posters
  • A Rangan. UKFROST enhanced dissemination - standardising physiotherapy pathways for frozen shoulder. BESS, ACC Liverpool. 23rd June, 2022.
  • A Rangan. UK FROST Frozen Shoulder Trial. BESS, ACC Liverpool. 22nd June 2022.
  • UK FROST trial team. UK FROST Frozen Shoulder Trial. BESS 2020 Virtual Conference. 13th-14th October 2020.
  • Simpson J, Keding A, Spencer S, Brealey S, Rangan A. Factor structure of the Oxford Shoulder Score: the UK FROST Trial Population of Adults with a Frozen Shoulder. British Elbow and Shoulder Society, Virtual meeting, 14th-16th October, 2020.
  • Dakin SG, Rangan A, Martinez FO, Brealey S, Northgraves M, Kottam L, Cooper C, Buckley CD, Carr AJ. Tissue Inflammation Signatures Suggest A Resolving Inflammatory Milieu In Frozen Shoulder. Orthopaedic Research Society, Phoenix, Arizona. February 8th-11th, 2020.
• Stakeholder engagement meetings
  • UK FROST Trial Team. UK FROST Enhanced Dissemination Project with key stakeholders. Virtual meeting. 26th January, 2023.
  • UK FROST Trial Team. UK FROST Enhanced Dissemination Project with key stakeholders. Virtual meeting. 19th January, 2023.
  • UK FROST Trial Team. UK FROST Enhanced Dissemination Project with key stakeholders. Principal York, 17th November 2022.

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