Efficacy and safety of a single intrathecal methylprednisolone bolus in chronic complex regional pain syndrome

Department of Neurology, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.
European journal of pain (London, England) (Impact Factor: 2.93). 12/2009; 14(5):523-8. DOI: 10.1016/j.ejpain.2009.11.004
Source: PubMed


Activated immune cells in the spinal cord may play an important role in the development and maintenance of neuropathic pain, such as occurs in response to peripheral inflammation or tissue injury. Immune activation may therefore serve as a therapeutic target for immune modulating drugs like corticosteroids. This double-blind randomized placebo-controlled parallel-group trial aimed to investigate the efficacy and safety of a single intrathecal administration of 60 mg methylprednisolone (ITM) in chronic patients with complex regional pain syndrome (CRPS). The primary outcome measure was change in pain (pain intensity numeric rating scale; range 0-10) after 6 weeks. With 21 subjects per group the study had a 90% power to detect a clinically relevant difference (> or = 2 points). After 21 patients (10 on ITM) were included, the trial was stopped prematurely after the interim analysis had shown that ITM had no effect on pain (difference in mean pain intensity numeric rating scale at 6 weeks 0.3, 95% confidence interval -0.7 to 1.3) or any other outcome measure. We did not find any difference in treatment-emergent adverse events between the ITM and placebo group. We conclude that a single bolus administration of ITM is not efficacious in chronic CRPS patients, which may indicate that spinal immune activation does not play an important role in this phase of the syndrome.

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    • "Sixty-eight outcome measures were identified from the 104 papers included in the review (Table 1). Four measures were adapted specifically for CRPS; Brief Pain Inventory adapted for CRPS (Van der Vusse et al., 2004), CRPS Limb Symptom Scale (Goebel et al., 2010) and global impression of change in CRPS signs and symptoms, both patient reported (Munts et al., 2009, 2010) and health professional reported (Munts et al., 2009, 2010; Van Der Plas et al., 2011, 2013). Sixty-four measures were generic . "
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    ABSTRACT: Complex Regional Pain Syndrome (CRPS) is a chronic pain condition, often triggered by trauma to a limb and characterized by sensory, motor, autonomic and trophic changes within the affected limb. Due to the multi-faceted nature of the condition there are a wide range of potential health outcome measures for use within CRPS related clinical trials. This aim of this systematic literature review was to identify which patient or health professional questionnaire format outcome measures have been used in CRPS specific clinical trials, and which of these have been developed specifically for use in CRPS populations. Information gained from this review will inform an international consortium project to define a Core Outcome measurement set for CRPS Clinical trials. The electronic databases EMBASE, Medline, PsycInfo, CINAHL and LILACS were systematically searched from January 2000 until April 2014. One hundred and four full text papers were obtained with 68 questionnaire outcome measures identified. Five of these outcome measures were validated for CRPS. Of those outcome measures used since 2000, those addressing physical functioning were most prevalent. Currently, CRPS clinical trials use a wide range of outcome measures making the potential to synthesize evidence problematic. There is no internationally agreed core measurement set. This diversity of outcome measures demonstrates a clear need for the development of a core measurement set to be used in CRPS clinical trials. © 2015 European Pain Federation - EFIC®
    No preview · Article · Jun 2015 · European journal of pain (London, England)
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    • "The commentary repeatedly states that late stage CRPS type I is to be regarded a neuropathic pain condition and argues, e.g., that ''signs of major peripheral nerve damage are not present when the diagnosis of CRPS-I is obvious often a long time after the initial injury, the inciting tissue damage may have partially damaged peripheral nerves, that later regenerated " . Labelling CRPS type I as a neuropathic condition is a view shared byMunts et al. (2010). Dr. Breivik also claims that ''Immunological processes are activated in the CNS in response to nerve injury (Hansson, in press); microglia (macrophages of the CNS) and astrocytes are activated and changes in the astrocyte networks and pain regulating mechanisms occur (Costigan et al., 2009;Hansson, 2010). "

    Preview · Article · May 2010 · European journal of pain (London, England)
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    ABSTRACT: We introduce several EM-based multiuser detectors for an optical CDMA system. The detectors have soft and hard stages. In the soft stage, a soft estimation of the interference is obtained by solving an unconstrained maximum-likelihood (ML) problem via an iterative expectation-maximization (EM) algorithm. Then, the hard stage detects the user information bit by solving a one-dimensional Boolean constrained problem conditioned on knowing the interference. Our results reveal that the proposed detectors have very low complexity and are robust against changes in parameters. Moreover. the numerical results illustrate that, despite their simplicity, our detectors substantially outperform other well-known suboptimum detectors, such as multistage and decorrelating detectors.
    No preview · Conference Paper · Feb 2002
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