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Bone & Joint Open
Vol. 5, Issue 3 | Pages 162 - 173
4 Mar 2024
Di Mascio L Hamborg T Mihaylova B Kassam J Shah B Stuart B Griffin XL

Aims

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.

Methods

In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.


Bone & Joint Open
Vol. 3, Issue 9 | Pages 701 - 709
2 Sep 2022
Thompson H Brealey S Cook E Hadi S Khan SHM Rangan A

Aims. To achieve expert clinical consensus in the delivery of hydrodilatation for the treatment of primary frozen shoulder to inform clinical practice and the design of an intervention for evaluation. Methods. We conducted a two-stage, electronic questionnaire-based, modified Delphi survey of shoulder experts in the UK NHS. Round one required positive, negative, or neutral ratings about hydrodilatation. In round two, each participant was reminded of their round one responses and the modal (or ‘group’) response from all participants. This allowed participants to modify their responses in round two. We proposed respectively mandating or encouraging elements of hydrodilatation with 100% and 90% positive consensus, and respectively disallowing or discouraging with 90% and 80% negative consensus. Other elements would be optional. Results. Between 4 August 2020 and 4 August 2021, shoulder experts from 47 hospitals in the UK completed the study. There were 106 participants (consultant upper limb orthopaedic surgeons, n = 50; consultant radiologists, n = 52; consultant physiotherapist, n = 1; extended scope physiotherapists, n = 3) who completed round one, of whom 97 (92%) completed round two. No elements of hydrodilatation were “mandated” (100% positive rating). Elements that were “encouraged” (≥ 80% positive rating) were the use of image guidance, local anaesthetic, normal saline, and steroids to deliver the injection. Injecting according to patient tolerance, physiotherapy, and home exercises were also “encouraged”. No elements were “discouraged” (≥ 80% negative rating) although using hypertonic saline was rated as being “disallowed” (≥ 90% negative rating). Conclusion. In the absence of rigorous evidence, our Delphi study allowed us to achieve expert consensus about positive, negative, and neutral ratings of hydrodilatation in the management of frozen shoulder in a hospital setting. This should inform clinical practice and the design of an intervention for evaluation. Cite this article: Bone Jt Open 2022;3(9):701–709


Bone & Joint Open
Vol. 2, Issue 9 | Pages 773 - 784
1 Sep 2021
Rex SS Kottam L McDaid C Brealey S Dias J Hewitt CE Keding A Lamb SE Wright K Rangan A

Aims. This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. Methods. MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder. Results. Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero. Conclusion. The findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open 2021;2(9):773–784


Bone & Joint Open
Vol. 2, Issue 8 | Pages 685 - 695
2 Aug 2021
Corbacho B Brealey S Keding A Richardson G Torgerson D Hewitt C McDaid C Rangan A

Aims

A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care.

Methods

A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods.


Bone & Joint 360
Vol. 10, Issue 1 | Pages 28 - 31
1 Feb 2021


Bone & Joint 360
Vol. 9, Issue 6 | Pages 31 - 33
1 Dec 2020


Bone & Joint 360
Vol. 7, Issue 4 | Pages 22 - 25
1 Aug 2018


The Bone & Joint Journal
Vol. 99-B, Issue 8 | Pages 1067 - 1072
1 Aug 2017
Booker SJ Boyd M Gallacher S Evans JP Auckland C Kitson J Thomas W Smith CD

Aims

Our aim was to investigate the prevalence of Propionibacterium (P.) acnes in the subcutaneous fat and capsule of patients undergoing shoulder surgery for frozen shoulder or instability.

Patients and Methods

A total of 46 patients undergoing either an arthroscopic capsular release or stabilisation had biopsies taken from the subcutaneous fat and capsule of the shoulder at the time of surgery. These samples were sent for culture in enrichment, and also for Nucleic Acid Amplification testing. The prevalence of P. acnes and other microbes was recorded. Fisher's exact test of binary variables was used to calculate the association with significance set at p < 0.05. Assessment of influence of independent variables including a pre-operative glenohumeral injection, fat colonisation and gender, was undertaken using binary linear regression.


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 963 - 966
1 Jul 2015
Evans JP Guyver PM Smith CD

Frozen shoulder is a recognised complication following simple arthroscopic shoulder procedures, but its exact incidence has not been reported. Our aim was to analyse a single-surgeon series of patients undergoing arthroscopic subacromial decompression (ASD; group 1) or ASD in combination with arthroscopic acromioclavicular joint (ACJ) excision (group 2), to establish the incidence of frozen shoulder post-operatively. Our secondary aim was to identify associated risk factors and to compare this cohort with a group of patients with primary frozen shoulder.

We undertook a retrospective analysis of 200 consecutive procedures performed between August 2011 and November 2013. Group 1 included 96 procedures and group 2 104 procedures. Frozen shoulder was diagnosed post-operatively using the British Elbow and Shoulder Society criteria. A comparative group from the same institution involved 136 patients undergoing arthroscopic capsular release for primary idiopathic frozen shoulder.

The incidence of frozen shoulder was 5.21% in group 1 and 5.71% in group 2. Age between 46 and 60 years (p = 0.002) and a previous idiopathic contralateral frozen shoulder (p < 0.001) were statistically significant risk factors for the development of secondary frozen shoulder. Comparison of baseline characteristics against the comparator groups showed no statistically significant differences for age, gender, diabetes and previous contralateral frozen shoulder.

These results suggest that the risk of frozen shoulder following simple arthroscopic procedures is just over 5%, with no increased risk if the ACJ is also excised. Patients aged between 46 and 60 years and a previous history of frozen shoulder increase the relative risk of secondary frozen shoulder by 7.8 (95% confidence interval (CI) 2.1 to 28.3)and 18.5 (95% CI 7.4 to 46.3) respectively.

Cite this article: Bone Joint J 2015; 97-B:963–6.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 570 - 570
1 Nov 2011
Ahmad ZI Ingham C Roberts C
Full Access

Purpose: Frozen shoulder, an excruciatingly painful condition known medically as adhesive capsulitis, affects two million people in Britain. Diabetics and women aged 40–60 are particularly at risk. The current treatment for frozen shoulder includes painkillers, physiotherapy, or surgery. The above presents their own problems, including recurrence of symptoms, failure of therapy, and for surgery: recovery period, anaesthetic and surgical operative risks. In contrast, the therapy involving hydrodilatation injections into the shoulder takes just ten minutes and allows patients to go home immediately. Hydrodilatation had fallen out of favour as a means of treating frozen shoulders until the recent publications specifically the King’s Lynn study (Quraishi et al) in 2007. Our objective is to see if we can reproduce these results that the King’s Lynn study shows. Method: Our study is a cohort study, prospectively evaluating the outcome of hydrodilatation as treatments for adhesive capsulitis. 24 patients were treated with hydrodilatation, and had Oxford scores done before injection; 2 months and 6 months after injection. The overall scores were recorded as was the range of movement. Results: The overall scores for the study showed a significant improvement and increased ROM of patients’ shoulders. Conclusion: We believe our study shows that hydrodilatation is an effective means of treating frozen shoulders. We believe our study demonstrates the need for hydrodilatation to be more widely practiced. Other therapy such as painkillers and physiotherapy has shown not to be effective, and surgery has its respective complications. Therefore hydrodilatation offers a minimally invasive, cheap, low risk alternative


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_II | Pages 215 - 215
1 Jul 2008
Quraishi MNA Johnston MP Bayer MJ Crowe DM Chakrabarti MA
Full Access

This is a prospectively randomised blind study to determine which treatment- Manipulation under anaesthesia (MUA) or Hydrodilatation is more effective for proven shoulder adhesive capsulitis. Forty patients with adhesive capsulitis were randomised to receive either of the two treatments. All patients were assessed by an independent investigator, with Visual Analogue Scores (VAS) and Constant scores, at three intervals “ pre-treatment, 2 months and 6 months following treatment. Twenty patients (mean age 55.2 years (44–70); duration of symptoms 33.7 weeks (8–76)) received hydrodilatation and eighteen (mean age 54.5 years (39–69); duration of symptoms 43.5 weeks (12–102)) underwent MUA (two patients dropped out). VAS scores in the hydrodilatation group were pre treatment 6.1 (n=20), 2.4 (n=18;p=0.001) at 2 months and 1.7 (n=17; p=0.0006) at 6 months. VAS scores in the MUA group were pre treatment 5.7 (n=18), 4.7 (n=16) at 2 months, and 2.7 (n=15;p=0.0006) at 6 months. The VAS pain scores in the hydrodilatation group were significantly better than the MUA group over the six month follow-up (p< 0.0001)Constant scores in the hydrodilatation group were 30.8 pre treatment, 57.4 (p=0.0004) at 2 months and 65.9 (p=0.0005) at 6 months. In the MUA group, Constant scores were 38 pre treatment, 60.2 (p=0.001) at 2 months and 59.5 (p=0.0006) at 6 months. Constant scores in the hydrodilataion group were again significantly better than the MUA group over the six month follow-up (p= 0.02). At final follow up, 93% of patients were satisfied or very satisfied after hydrodilatation compared to 71% of those receiving an MUA. We have for the first time prospectively measured the outcome of two treatments “ MUA and hydrodilatation in patients with adhesive capsulitis. Our results suggest that although both treatments are effective in the majority of patients, hydrodilatation is significantly more effective than a manipulation under anaesthesia


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 9 | Pages 1197 - 1200
1 Sep 2007
Quraishi NA Johnston P Bayer J Crowe M Chakrabarti AJ

This study prospectively evaluated the outcome of manipulation under anaesthesia and hydrodilatation as treatments for adhesive capsulitis. A total of 36 patients (38 shoulders) were randomised to receive either method, with all patients being treated in stage II of the disease process. The mean age of the patients was 55.2 years (44 to 70) and the mean duration of symptoms was 33.7 weeks (12 to 76). Eighteen shoulders (17 patients) underwent manipulation under anaesthesia and 20 (19 patients) had hydrodilatation. There were three insulin-dependent diabetics in each group. The mean visual analogue score in the manipulation under anaesthesia group was 5.7 (3 to 8.5; n = 18) before treatment, 4.7 (0 to 8.5; n = 16) at two months (paired t-test p = 0.02), and 2.7 (0 to 9; n = 16) at six months (paired t-test, p = 0.0006). The mean score in the hydrodilatation group was 6.1 (4 to 10; n = 20) before treatment, 2.4 (0 to 8; n = 18) at two months (paired t-test, p = 0.001), and 1.7 (0 to 7; n = 18) at six months (paired t-test, p = 0.0006). The visual analogue scores in the hydrodilatation group were significantly better than in the manipulation under anaesthesia group over the six-month follow-up period (p < 0.0001). The mean Constant score in those manipulated was 36 (26 to 66) before treatment, 58.5 (24 to 90) at two months (paired t-test, p = 0.001) and 59.5 (23 to 85) at six months (paired t-test, p = 0.0006). In the hydrodilatation group it was 28.8 (18 to 55) before treatment, 57.4 (17 to 80) at two months (paired t-test, p = 0.0004) and 65.9 (28 to 92) at six months (paired t-test, p = 0.0005). The Constant scores in the hydrodilatation group were significantly better than in the manipulated group over the six-month period of follow-up (p = 0.02). The range of movement improved in all patients over the six months, but was not significantly different between the groups. At the final follow-up, 94% of patients (17 of 18) were satisfied or very satisfied after hydrodilatation compared with 81% (13 of 16) of those receiving a manipulation. Most of our patients were treated successfully, but those undergoing hydrodilatation did better than those who were manipulated