Rheumatology Advance Access originally published online on January 11, 2008
Rheumatology 2008 47(2):230-231; doi:10.1093/rheumatology/kem340
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Comment on: A prospective double blind placebo-controlled randomized trial of ultrasound in the physiotherapy treatment of shoulder pain: reply
1School of Health Sciences, University of Birmingham, Birmingham, 2Physiotherapy Department, Torbay Hospital, Lawes Bridge, Torquay, 3Primary Care Musculoskeletal Research Centre, Keele University, Keele, 4Warwick Clinical Trials Unit, University of Warwick, Coventry and 5Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK
Correspondence to: Ainsworth, Physiotherapy Department, Torbay Hospital, Lawes Bridge, Torquay, TQ2 7AA, UK. E-mail: roberta.ainsworth{at}nhs.net
SIR, We thank the editor for the opportunity to reply to the letter [1] in response to our paper, ‘A prospective double blind placebo-controlled trial of ultrasound in the physiotherapy treatment of shoulder pain’ [2].
This was a pragmatic multicentre study in primary care and answered a question considered of importance to clinical and research physiotherapists working within the West Midlands region of the UK. Koel [1] highlights the limitations of the pragmatic design and cites a number of studies to support his argument. Many of these, however, were not published at the time our research question was developed with our clinical partners. One exception was an efficacy study targeting a highly selected subgroup of shoulder conditions verified by radiography [3]. Patients received twenty four 15 min sessions of ultrasound or placebo ultrasound. The first 15 treatments were given daily (five times per week). Such a lengthy course of treatment would not be feasible in the National Health Service (NHS) in the UK.
Whilst we acknowledge that pragmatic randomized controlled clinical trials (RCTs) have limitations, our design is similar to other studies in primary care [4–8]. For instance, packages of care are commonly evaluated rather than individual modalities, reflecting usual practice in UK NHS physiotherapy clinics. Additionally, the primary outcome in such studies is frequently disability [4–8], which reflects what is important to patients.
Pragmatic clinical trials can ask ‘is this treatment helpful on average for a wide range of patients?’ We therefore recruited eligible patients with soft tissue shoulder disorders to ensure large numbers of patients to answer the question. However, our study was not large enough to undertake subgroup analysis. Whilst it is possible that therapeutic ultrasound may be beneficial in highly selected diagnostic subgroups, we are less certain than Koel [1] that specific shoulder disorders occur in isolation and can be easily identified in primary care for subgroup analysis. Palmer et al. [9] found that of all the upper-limb disorders, the shoulder was the most difficult to categorize and diagnostic groups overlapped.
Our study question and eligibility criteria were developed through consensus with experienced UK musculoskeletal physiotherapy practitioners and researchers. Physiotherapy practice is frequently based on treatment packages tailored to individual patients. It was therefore important to work closely with clinicians in order to develop an intervention package that enabled an individual practitioner to provide treatment in line with usual practice without compromising the design of the trial. Our interventions were formulated using the best available evidence at the time. Clinical reasoning was used by physiotherapists in applying this evidence to individual patients and in recording individual clinical diagnoses (data not shown). Dosages of ultrasound reflected current local practice in the absence of clear recommendations from the literature [4, 10, 11].
Koel [1] also has concerns over the protocol used for the other components of the package of physiotherapy care, namely advice and exercise and manual therapy. A standard protocol was used for these interventions [10] and was based on those developed previously in the study by Hay et al. [4]. A treatment protocol was developed that was tailored to align with the randomized controlled trial, but enabled physiotherapists to modify their approach according to the patient's clinical presentation.
We agree with Koel [1] that there is a need for further well-designed studies as part of the development of evidence-based physiotherapy treatment of shoulder disorders in primary care.
Disclosure statement: The authors have declared no conflicts of interest.
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- Ainsworth R, Dziedzic K, Hiller L, Daniels J, Bruton A, Broadfield J. A prospective double blind placebo-controlled randomized trial of ultrasound in the physiotherapy treatment of shoulder pain. Rheumatology (2007) 46:815–20.
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