Written By: C. Allen Witt (Duke University) & the RheumMadness Leadership Team
Based on: Rangan 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;396(10256):977-89 (pubmed link)
Adhesive Capsulitis (Frozen Shoulder) results in gradual loss of passive and active range of motion in the glenohumeral joint and is usually accompanied by severe pain. Plain radiographs usually only show evidence of osteopenia though there are some non-specific inflammatory or post-inflammatory soft tissue findings on Ultrasound and MRI. It occurs in 8.2% of men and 10.1% of women of working age. This condition is sually self-limited with functional limitation and pain lasting 2-3 years but 40% of patients have persistent mild symptoms and 6% with severe pain and loss of function at 4 years2.
Current UK national physiotherapy guidelines recommend exercise and manual therapy either in isolation or to supplement steroid injection (CSI) , manipulation under anesthesia (MUA) or arthroscopic capsular release (ACR). The purpose of this trial was to determine any potential difference in efficacy or cost effectiveness of CSI + early structured physiotherapy vs MUA vs ACR.
This was a multicenter, pragmatic, superiority randomized trial comparing the three parallel groups. All patients were referred to secondary care for primary frozen shoulder. Patients with symptoms secondary to trauma, radiographic evidence of other cause or unable to tolerate surgery were excluded. Participants were randomly allocated in a respective 2:2:1 ratio to arthroscopic capsular release, manipulation under anesthesia, or steroid injection then early structured physiotherapy. Procedural groups also got the same physiotherapy post procedure. Primary outcome was the Oxford Shoulder Score (OSS), a 12 item patient-reported measure of pain and function. Other outcomes included visual analogue scale (0-100) of patient-perceived extent of recovery. All outcome measures conducted at 3, 6, and 12 months after randomization. Cost Effectiveness of each therapy in the UK health system was also an outcome measure, taking into account for each group the cost of initial intervention, hospitalizations and any further interventions in the 12-month period. In terms of results, there was no clinical difference in effectiveness between the three groups. Capsular Release was associated with greater risk of adverse events. Manipulation under anesthesia was considered most cost effective based on elaborate statistical modeling. Patients who got early physiotherapy were more likely to pursue additional therapies, but also the only group without any serious adverse effects.
Implications for Patients, Providers, & Researchers
Steroid injection and 12 weeks of appropriate physiotherapy is just as effective as the most popular procedural options for patients referred to secondary care for primary frozen shoulder. This has enormous implications for patients who are concerned about or at higher risk for adverse events from procedures. For providers this means that prior to referral to surgery there should at least be a discussion about starting PT or re-starting PT, perhaps with a different therapist than was originally used. If patients are insistent on procedure, it seems that manipulation may be the most reasonable option given relative safety and cost effectiveness. This is a practice changing study for a difficult-to-treat, painful and disabling condition that affects a large proportion of workers. If the cost-effectiveness data translates well into healthcare settings beyond the UK, these findings could lead to large savings in healthcare expenditures without changing efficacy of treatment or patient perception of wellness.
60% of all the patients in this study had already completed PT for the same shoulder with same symptoms. Patients had on average, 10.5 months of symptoms prior to randomizations, so the endpoint of 12 months means ~2 years post onset. This implies that not all PT is created equal and/or multiple rounds of PT are often required. No additional training was necessary and standard therapies for were used for the structured PT but the protocol was developed specifically for the study and was based on a survey of UK shoulder specialist physiotherapists3. If, as this study has shown, early PT can be safer and just as effective for patients then perhaps we should more closely examine the regimens and delivery models for PT. It would be interesting to see this same structured early PT program implemented nearer to onset of symptoms in a research study which may help answer the important question of whether these patients could start benefiting earlier in the course.
Will UK Frost for Frozen Shoulder Win its First Round Match-up?
Its first opponent, PT vs CSI for Knee OA is similar in many ways; both represent a win for Physical therapy over procedural care. The CSI vs PT in Knee OA trial is a very clean 1:1 design that a great job of showing that PT is better than steroid injection. I’m not sure how practice changing this really will be though given that the study did not look at steroid injection + physical therapy which is a common treatment that I suspect will continue and may be superior to either treatment alone. Also, UK FROST had a more robust sample size and so were able to clearly demonstrate the clinical soundness of avoiding surgery or procedure under anesthesia thus avoiding all the costs and morbidities that go along with it. It is a study that leads to reduction of truly serious adverse events and saves millions of dollars in healthcare costs. UK Frost will undoubtedly give CSI vs PT the proverbial “cold shoulder” on its way to the next round.
Could UK Frost Win it All?
It ticks all the boxes. Is it practice changing? Check. Is it practice changing in a way that will substantially save healthcare costs? Check. Will it lead to reduction in serious adverse effects and morbidity for patients? Check. That being said, it can be difficult for a team out of the MSK bracket to go all the way when it is not a classic autoimmune Rheumatological disease. For this reason, this team is a dark horse but its potential to add value to patient care is tremendous. I think it will clear the first round but may have difficulty contending with other trials looking at therapy for more traditional Rheum disorders (i.e. SEMIRA).
- 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. 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. doi: 10.1016/S0140-6736(20)31965-6. Erratum in: Lancet. 2021 Jan 9;397(10269):98. PMID: 33010843.
- Hand C, Clipsham K, Rees JL, Carr AJ. Long-term outcome of frozen shoulder. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):231-6. doi: 10.1016/j.jse.2007.05.009. Epub 2007 Nov 12. PMID: 17993282.
- Hanchard NCA, Goodchild L, Brealey SD, Lamb SE, Rangan A. 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. doi: 10.1016/j.physio.2019.07.004. Epub 2019 Jul 19. PMID: 32026815.