Researchers lead largest clinical trial of its kind

Posted on in Research

Prof Amar Rangan with a patient

Professor Amar Rangan carrying out a recent shoulder examination at The James Cook University Hospital

Research departments from The James Cook University Hospital and the University of York have teamed up to lead the largest clinical trial of its kind comparing treatment options for frozen shoulders.

The results of the National Institute for Health Research (NIHR) funded UK FROST trial, published in The Lancet on Thursday 1 October, show keyhole surgery is no better at treating a frozen shoulder than two alternative therapies which are less invasive.

Frozen shoulder is a common and painful condition in which movements in the shoulder become restricted. It affects around 10% of women and 8% of men of working age and can last for years.

Diabetics with a frozen shoulder are more likely to be resistant to treatment and suffer worse symptoms, while those with stroke and cardiac conditions are also vulnerable to having a frozen shoulder.

A common surgical treatment is arthroscopic capsular release (ACR), a keyhole procedure under general anaesthetic where a probe is inserted into the shoulder, along with a camera and the joint capsule is released, stretched and manipulated to regain a range of movement. This is a costly and invasive treatment.

However, in the largest clinical trial of its kind, NIHR researchers led by a team at South Tees Hospitals NHS Foundation Trust and University of York Trials Unit, have found that ACR was no more effective than two other less costly and less invasive treatments using a patient-reported questionnaire about shoulder pain and function.

One was manipulation under anaesthesia (MUA) – a minimally invasive procedure where surgeons move the shoulder joint to a full range of motion. The other was early structured physiotherapy (ESP) with a steroid injection – a treatment specially designed for the trial that does not require a general anaesthetic.

Professor Amar Rangan, chief investigator and consultant orthopaedic surgeon at South Tees, said: “Frozen shoulder is a common condition for which thousands of people annually need hospital treatment because of the pain they are in and because they are struggling with daily activities, sleep and work.

“Our trial has shown that expensive keyhole surgery is no better than two alternative therapies. This could provide more choice for patients – especially those with conditions like diabetes who have to manage a chronic disease and who may not want the additional inconvenience and risk of surgery under anaesthetic.”

The randomised controlled trial was carried out in 35 UK hospitals. More than 500 patients took part with 203 receiving ACR and 201 MUA. The remaining 99 underwent ESP.

All three treatments led to substantial improvements in patient reported shoulder pain and function over one year, but none of the treatments proved superior.

Although ACR resulted in the least number of further treatments: 4%, compared to 7% for MUA and 15% for ESP, it carried relatively higher risks, mostly general risks from having a surgical procedure, and had longer waiting times to access.

ESP with a steroid injection could be accessed quickly, had relatively fewer risks than ACR and was cheaper, but more patients required further treatment.

Overall MUA was found to be the most cost-effective option that provided the NHS with the best value for money spent in terms of health gains for the patient.

Professor Caroline Wroe, clinical director at NIHR Clinical Research Network North East and North Cumbria, said: “We’re delighted to see positive research findings into such a limiting and painful condition as frozen shoulder. The hard work carried out collaboratively by healthcare and academia in our region demonstrates how researchers are continuing to successfully work together, deliver clinical trials and communicate their results to change practice.

“By providing more clarity around treatment options, the NIHR can not only impact and improve the care patients receive but also streamline vital services and staff times to help the NHS cope in strenuous circumstances.”

Professor Melanie Davies, director, NIHR Leicester Biomedical Research Centre, said: “This study provides important evidence indicating less invasive therapies have similar outcomes to surgery for patients with this common condition which often affects those with diabetes, stroke and cardiac conditions.

“Once again NIHR is funding and supporting crucial research which can inform clinicians and those who manage health and care services and makes a real difference to patient care.”

Professor Rangan added: “At a time when NHS resources are stretched, encouraging surgeons to use keyhole surgery more selectively when less costly and less invasive interventions fail could save valuable theatre time and limit the need for people to undergo unnecessary lengthy procedures.”

The trial was funded by the NIHR’s Health Technology Assessment (HTA) Programme and the study was supported by the NIHR Clinical Research Network (CRN). More information on the study is available on the NIHR Funding and Awards website.

Video reproduced with kind permission from Science Animated