The effects of spinal mobilizations on the sympathetic nervous system: a systematic review.

The activity of the sympathetic nervous system is of importance to manual therapists, since the experience of pain is associated with sympathetic activity. There has been little exploration into the effects of mobilizing vertebral segments below the cervical spine. In addition to this, a synthesis of the evidence for changes in sympathetic outcome measures has not been completed. The primary aim of this review was to investigate the effects of spinal mobilizations compared to a control or placebo on sympathetic outcome measures. The secondary aim was to establish the level of change, either excitatory or inhibitory, in sympathetic outcome measures. Five electronic databases (Ovid Medline, Embase, AMED, PEDro, and the Cochrane library; from database inception to May 2012) were searched for randomized controlled trials. Two independent raters applied inclusion criteria and rated studies for methodological quality. Seven studies met the inclusion criteria. All studies demonstrated a consistent increase in sympathetic outcome measures, indicative of sympathetic excitation, irrespective of the segments mobilized. Synthesis of the results established strong evidence (multiple high-quality randomised controlled trials (RCTs) for a positive change in skin conductance, respiratory rate, blood pressure, and heart rate among the healthy population. As only one study investigated changes in a symptomatic population, there was limited evidence (one RCT) for an increase in skin conductance and decrease in skin temperature. Evidence from this systematic review supports a sympatho-excitatory response to spinal mobilizations irrespective of the segment mobilized.

Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: a multi-centre, double-masked, factorial randomised controlled trial.

BACKGROUND: Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed.The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. METHODS/DESIGN: Patients with active thyroid eye disease will be randomised to receive (i) azathioprine or oral placebo and (ii) radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure) at 12 months and secondary end-points include quality of life scores and health economic measures. DISCUSSION: The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a) robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b) constructing effective inclusion and exclusion criteria to select for active disease; and (c) selecting pragmatic outcome measures. TRIAL REGISTRATION: Current controlled trials ISRCTN22471573.