The purpose of this report is to present the detailed statistical analysis of a randomised, placebo-controlled trial comparing two different treatment modalities to an intervention of no known benefit for people with acute or subacute thoracic spine pain.
The therapy arms consist of Spinal Manipulative Therapy (SMT) and Graston Technique (GT) and the placebo is a non-functional ultrasound. A placebo group was utilised because at present there are no proven treatments for non-specific thoracic pain. This trial is registered with the Australia and New Zealand Clinical Trials Registry. Ethics approval has been granted by Murdoch University Human Research and Ethics Committee, number 2007/274.
The aim of this three arm trial was to test the efficacy of SMT and GT as independent modalities compared to detuned ultrasound for the outcomes of pain and disability. The latter were measured using the Visual Analogue Scale (VAS) and a modified Oswestry Back Pain Disability Index. The study was conducted at the Murdoch University Chiropractic student clinic in Perth, Australia, and the protocol published in Crothers et al (2008).
In this report, Section 2 provides an initial exploratory analysis of the data, Section 3 outlines the statistical models used in the final analysis, Section 4 defines these models in mathematical terms, Section 5 discusses the management of missing values via multiple imputation and Section 6 presents the results of the statistical modelling and hypothesis tests. The clinical study will be published in full elsewhere