Trial of Ultrasound

Trial of Ultrasound

1) What is the rationale for this study?

A systematic review of randomized clinical trials for soft tissue disorders concluded that therapeutic ultrasound (US) was not an effective treatment in the physiotherapy management of shoulder pain . However, this review also highlighted the poor methodological quality of most of the physiotherapy trials evaluated. Partly due to this, the findings of the systematic review carried little weight within the UK physiotherapy community

2) What are the study's aims? Do these follow logically from the rationale?

To compare the effectiveness of manual therapy and ultrasound (US) with manual therapy and placebo ultrasound (placebo US) in the treatment of new episodes of unilateral shoulder pain referred for physiotherapy.

3) What ethical issues are there with this study?

This was a multicentre, double blind, pragmatical randomized controlled trial in nine primary care physiotherapy treatment facilities in Birmingham, UK. Ethical approval was granted by the local research ethics committees of North, East and West Birmingham. Written informed consent was obtained from all participants prior to randomization.

4) The study is a randomized controlled trial? What are the main advantages of this trial design over a cohort study?

A randomized controlled trial (RCT) is a type of scientific experiment most commonly used in testing the efficacy or effectiveness of healthcare services (such as medicine or nursing) or health technologies (such as pharmaceuticals, medical devices or surgery). RCTs involve the random allocation of different interventions (treatments or conditions) to subjects. The most important advantage of proper randomization is that "it eliminates selection bias, balancing both known and unknown prognostic factors, in the assignment of treatments."

The terms "RCT" and randomized trial are often used synonymously, but some authors distinguish between "RCTs" which compare treatment groups with control groups not receiving treatment (as in a placebo-controlled study), and "randomized trials" which can compare multiple treatment groups with each other. RCTs are sometimes known as randomized control trials. RCTs are also called randomized clinical trials or randomized controlled clinical trials when they concern clinical research ; however, RCTs are also employed in other research areas such as criminology, education, and international development.

5) What are the inclusion/exclusion criteria for this study? How does this affect the generalisability of the study?

Whilst the pragmatic approach could be considered a weakness, in stratifying the patients into capsular and non-capsular patterns this followed an approach commonly adopted in practice. A specific diagnosis often involves costly, intrusive and untimely tests and the findings may not reflect accurately the cause of a patient's pain . Whilst we recognize that there is a wide variation in both the skill of clinicians and their chosen management, additional to the US, attempts were made to ensure that any interventions used were based on sound clinical reasoning. This was undertaken by inclusion of all treating physiotherapists in a training day prior to the study launch covering the trial protocol, a refresher course on shoulder treatment techniques and the clinical application of therapeutic US.

The physiotherapy training session included the concept of ...