14 research outputs found

    The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial

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    Contains fulltext : 109801.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND: Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study. After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted. The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1. Methods/design This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version. DISCUSSION: This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories. Trial registration Clinical trials NCT00817128; National Trial Register NTR2090

    Comparability, stability, and reliability of internet-based mental chronometry in domestic and laboratory settings

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    Internet-based assessment of response time (RT) and error rate (ERR) has recently become a well validated alternative to traditional laboratory-based assessment, because methodological research provided evidence for negligible setting- and setup-related differences in RT and ERR measures of central tendency. However, corresponding data on potential differences in the variability of such performance measures are still lacking to date. Hence, it was the aim of this study to conduct internet- based mental chronometry in both, poorly standardized domestic and highly standardized laboratory environments and to compare the variability of the corresponding performance measures. Using the Millisecond Inquisit4Web software, 127 men and women completed three different RT-based cognitive paradigms (i.e., Go/Nogo, 2-Back, Number-Letter). Each participant completed all paradigms in two environments (i.e., at home and in the laboratory) with a time lag of seven days in a counterbalanced order. Mixed-effects modeling was employed to estimate the between-setting variability across a comprehensive set of performance measures, including conventional measures of central tendency (i.e., mean RT and ERR) and further measures characterizing the joint distribution of RT/ERR. The latter were estimated using the diffusion model. Results suggested negligible differences between domestic and laboratory settings. Thus, this study provides novel evidence suggesting that the statistical power of internet-based mental chronometry is commonly not compromised by increased environmental variance. Within- and between-session reliabilities were in a satisfactory range, that is, comparable to performance measures collected offline in laboratory settings. In consequence, our results support the broad applicability, robustness, and cost-efficiency of mental chronometry assessment using the internet
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