United Kingdom Frozen Shoulder Trial (UK FroST)

Conditions

Frozen shoulder (adhesive capsulitis) Musculoskeletal Diseases Adhesive capsulitis of shoulder

Clark NL, Johnson M, Kottam L, Brealey S, Adamson J, Rangan A, UK FROST Stakeholder Group.

2025-05-30

Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study

Cynthia Srikesavan, Francine Toyé, Stephen Brealey, Lorna Goodchild, Matthew Northgraves et al. (8 authors)

BMJ Open2021-06-014 citations

10.1136/bmjopen-2020-040829

Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT

Stephen Brealey, Matthew Northgraves, Lucksy Kottam, Ada Keding, Belén Corbacho et al. (26 authors)

Health Technology Assessment2020-12-0133 citations

10.3310/hta24710

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

Rangan A, Brealey SD, Keding A, Corbacho B, Northgraves M, Kottam L, Goodchild L, Srikesavan C, Rex S, Charalambous CP, Hanchard N, Armstrong A, Brooksbank A, Carr A, Cooper C, Dias JJ, Donnelly I, Hewitt C, Lamb SE, McDaid C, Richardson G, Rodgers S, Sharp E, Spencer S, Torgerson D, Toye F, UK FROST Study Group.

2020-10-01124 citations

10.1016/s0140-6736(20)31965-6

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

Stephen Brealey, Alison Armstrong, Andrew Brooksbank, Andrew Carr, Charalambos Panayiotou Charalambous et al. (24 authors)

Trials2017-12-0129 citations

10.1186/s13063-017-2352-2

Interventions

Participants will be randomly allocated into one of three groups: 1. Evidence based, early structured physiotherapy (ESP) for 12 weeks (' active control') based on national clinical guidelines for man

instruction on exercises from gentle active, gentle pendular movements in comfortable range to stretches of the tightened capsule augmented by hands-on mobilisation techniques, applied by the physioth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with frozen shoulder, including diabetics, >=18 years old 2. Passive external rotation in the affected shoulder that is <50% of the contralateral shoulder 3. Radiographs to exclude secondary causes e.g. glenohumeral arthritis

Exclusion criteria

Exclusion criteria: 1. Bilateral concurrent frozen shoulders 2. Secondary to trauma or other causes 3. Trial treatments contraindicated 4. Unfit for general anaesthesia 5. Not resident to trauma catchment area of a participating trial site 6. Lack mental capacity to comply with treatment or data collection

Design outcomes

Primary

Measure	Time frame
Oxford Shoulder Score (OSS) (12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment) assessed at 3, 6 and 12 months post randomisation. Primary time point is 12 months after randomisation. OSS will also be collected at pre-treatment, as well as 6 months post-treatment	—

Secondary

Measure	Time frame
1. Disabilities of Arm Shoulder and Hand (DASH) - The QuickDASH will be measured at baseline, 3, 6 and 12 months. 2. Medical Outcomes Study Short Form 36-item questionnaire (MOS SF-36) to assess health related quality of life - will be collected at baseline, 3, 6 and 12 months. 3. The EQ5D-5L, generic and health economic self-complete patient-reported outcome measure - will be collected at baseline, 3, 6 and 12 months. 4. Pain measured using the Numeric Rating Scale for pain - will be collected at baseline, 3, 6 and 12 months. 5. Time to resolution- a simple subjective global question to be administered at baseline, 3, 6 and 12 months 6. Complications - All complications will be recorded at 12 months 7. Adverse events- will be collected over 12 months 8. The economic evaluation to determine the relative cost-effectiveness of three interventions for the treatment of frozen shoulder- at baseline, 3, 6 and 12 months 9. Qualitative study (Up to 45 patients and 10 to 15 health care professionals) - at 12 months	—

Measure

Time frame

1. Disabilities of Arm Shoulder and Hand (DASH) - The QuickDASH will be measured at baseline, 3, 6 and 12 months. 2. Medical Outcomes Study Short Form 36-item questionnaire (MOS SF-36) to assess health related quality of life - will be collected at baseline, 3, 6 and 12 months. 3. The EQ5D-5L, generic and health economic self-complete patient-reported outcome measure - will be collected at baseline, 3, 6 and 12 months. 4. Pain measured using the Numeric Rating Scale for pain - will be collected at baseline, 3, 6 and 12 months. 5. Time to resolution- a simple subjective global question to be administered at baseline, 3, 6 and 12 months 6. Complications - All complications will be recorded at 12 months 7. Adverse events- will be collected over 12 months 8. The economic evaluation to determine the relative cost-effectiveness of three interventions for the treatment of frozen shoulder- at baseline, 3, 6 and 12 months 9. Qualitative study (Up to 45 patients and 10 to 15 health care professionals) - at 12 months

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Countries

England, United Kingdom

Outcome results

None listed