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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    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®
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    ABSTRACT: Over the last 15 years, clinical and experimental data have emerged that suggest that peripheral and central, glial-mediated neuroimmune activation is both necessary and sufficient to sustain chronic pain. Immune modulation appears to be, therefore, a possible new therapeutic option. The Medline database and international trial registry databases were searched using the keywords "intravenous immunoglobulin" or "IVIG," "pain" or "chronic pain," "neuropathic pain," "CRPS," "complex regional pain syndrome" or "fibromyalgia." Evidence from RCTs suggest that IVIG is effective to reduce pain in complex regional pain syndrome (low-dose IVIG) and post-polio syndrome (high-dose IVIG), and open trials have suggested efficacy in additional pain conditions. IVIG therapy may emerge as a novel treatment modality for refractory cases. However, before this drug can be confidently used by clinicians, important questions need to be answered concerning optimal treatment doses, duration of treatment, and its effect on function and quality of life.
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