scholarly journals A randomised placebo-controlled Phase III multicentre trial: low-dose intravenous immunoglobulin treatment for long-standing complex regional pain syndrome (LIPS trial)

2017 ◽  
Vol 4 (5) ◽  
pp. 1-82 ◽  
Author(s):  
Andreas Goebel ◽  
Jatinder Bisla ◽  
Roy Carganillo ◽  
Claire Cole ◽  
Bernhard Frank ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Intravenous Immunoglobulin ◽  
Complex Regional Pain Syndrome ◽  
Primary Outcome ◽  
Low Dose ◽  
Multicentre Trial ◽  
Pain Syndrome ◽  
Phase Iii ◽  
Significant Difference ◽  
Average Pain

Background Complex regional pain syndrome (CRPS) is a rare, severe post-traumatic pain condition affecting distal limbs. Patients who do not spontaneously improve in 12 months are classed as having ‘long-standing CRPS’ and often cannot be effectively treated, leading to a poor prognosis. CRPS is associated with functional autoantibodies. Two small trials, including a randomised controlled trial, have suggested that low-dose intravenous immunoglobulin (IVIg) may be an effective treatment for some patients. Objective We hypothesised that low-dose IVIg is effective for reducing pain in long-standing CRPS. Methods A randomised, double blinded placebo-controlled multicentre trial in seven UK pain management centres. Patients were eligible if they had moderate or severe long-standing CRPS that they had experienced for up to 5 years. Participants were randomly allocated to receive 0.5 g/kg IVIg, the active intervention, or visually indistinguishable 0.1% albumin in saline placebo. Randomisation was initiated by study sites via an independent online randomisation system and was 1 : 1 with varying block sizes, stratified by study centre. Participants, investigators and assessors were blinded to group assignment. The study drug/placebo was infused intravenously at the study centres on day 1 and day 23 after randomisation. The primary outcome was the 24-hour average pain intensity between day 6 and day 42, on an 11-point (0–10) numeric rating scale, compared between the groups. Outcomes were analysed using a mixed-effects regression model that used 37 measurements of pain intensity (the primary outcome) per participant. All patients who received an infusion and provided any outcome were included in the intention-to-treat analysis. Results A total of 111 patients were recruited and assigned between 27 August 2013 and 28 October 2015. Three patients were excluded because they had been inappropriately randomised, five patients were withdrawn from the primary analysis because they provided no outcomes and 103 patients were analysed for the primary outcome. The average pain score in the IVIg group was 0.27 units (95% confidence interval –0.24 to 0.80 units) higher than in the placebo group. Therefore, there is no significant evidence of a treatment effect at the 5% level and there was no significant difference between groups. Six serious adverse events but no suspected unexpected serious adverse reactions were reported during the blinded and open-label phase. Conclusion and future work Low-dose immunoglobulin was not effective in relieving pain in patients with moderate to severe CRPS of 1–5 years’ duration. Better drug treatments for long-standing CRPS are urgently required. Trial registration Current Controlled Trials ISRCTN42179756. Funding This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership. Additional funding was obtained by the Pain Relief Foundation. Biotest UK Ltd provided the active study medication at no cost.

A randomized controlled trial of amitriptyline versus gabapentin for complex regional pain syndrome type I and neuropathic pain in children

2016 ◽  
Vol 13 (1) ◽  
pp. 156-163 ◽  
Author(s):  
Stephen Brown ◽  
Bradley Johnston ◽  
Khush Amaria ◽  
Jessica Watkins ◽  
Fiona Campbell ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Pain Intensity ◽  
Complex Regional Pain Syndrome ◽  
Pain Syndrome ◽  
Type I ◽  
Syndrome Type ◽  
Care Providers ◽  
First Line ◽  
Significant Difference

AbstractBackgroundTreatment of neuropathic pain in children is challenging, and requires a multimodal approach of pharmacologic, physical, and psychological therapies; however there is little evidence to guide practice. Amitriptyline and gabapentin are first-line drugs for treating neuropathic pain in adults, yet no studies have examined their efficacy, or compared them directly, to determine which might be better for pain relief and sleep disturbance in children.MethodsAfter informed consent was obtained, 34 patients aged 7–18 years diagnosed with complex regional pain syndrome type I (CRPS I) or a neuropathic pain condition were randomly allocated to receive either amitriptyline or gabapentin. Patients were followed for 6 weeks and assessed for pain intensity, sleep quality and adverse events. We blinded study personnel, including health-care providers, participants, parents, the research coordinator and the data analyst. Patients then completed quantitative sensory testing (QST) and a psychosocial pain assessment with the team psychologist, within 1–3 days of the start of the trial.ResultsAt the end of the 6-week trial, patients on both drugs had important reductions in pain, having surpassed the minimally important difference (MID) of 1. The difference between the groups however was not statistically significant. For the secondary outcomes, we found no statistically significant difference between the two drugs in sleep score or adverse events suggesting that both drugs improve sleep score to a similar degree and are equally safe.ConclusionsAmitriptyline and gabapentin significantly decreased pain intensity scores and improved sleep. There were no significant differences between the two drugs in their effects on pain reduction or sleep disability.ImplicationsAlthough larger, multi-centred trials are needed to confirm our findings, including longterm follow-up, both drugs appear to be safe and effective in treating paediatric patients in the first-line treatment of CRPS I and neuropathic pain over 6-weeks.

Low-Dose Intravenous Immunoglobulin Treatment for Long-Standing Complex Regional Pain Syndrome

2017 ◽  
Vol 167 (7) ◽  
pp. 476 ◽  
Author(s):  
Andreas Goebel ◽  
Jatinder Bisla ◽  
Roy Carganillo ◽  
Bernhard Frank ◽  
Rima Gupta ◽  
...  
Keyword(s):  
Intravenous Immunoglobulin ◽  
Complex Regional Pain Syndrome ◽  
Low Dose ◽  
Pain Syndrome ◽  
Immunoglobulin Treatment

INR Response to Low-Dose Vitamin K in Warfarin Patients

2021 ◽  
pp. 106002802199323
Author(s):  
Caitlin E. Kulig ◽  
A. Joshua Roberts ◽  
A. Shaun Rowe ◽  
Hahyoon Kim ◽  
William E. Dager
Keyword(s):  
Vitamin K ◽  
Primary Outcome ◽  
Low Dose ◽  
International Normalized Ratio ◽  
Mortality Rates ◽  
Observational Cohort Study ◽  
Significant Difference ◽  
Observational Cohort ◽  
Reduction Effect ◽  
Retrospective Observational Cohort Study

Background Literature suggests that 2 mg of vitamin K intravenously (IV) provides a similar effect as 10 mg to reverse warfarin. Doses <5 mg haven’t been studied in depth. Objective The objective was to determine the international normalized ratio (INR) reduction effect of ultra low-dose (ULD) IV vitamin K. Methods This retrospective, observational cohort study compared IV vitamin K doses of 0.25-0.5 mg (ULD) versus 1-2 mg (standard low dose [SLD]). The primary outcome assessed ΔINR at 36 hours; secondary outcomes assessed ΔINR at 12 hours and 30-day venous thromboembolism (VTE) and mortality rates. Results Of 88 patients identified (median baseline INR [IQR], 5.1 [3.1, 7.3] vs 4.5 [2.8, 8.2], ULD vs SLD, respectively), 59 had an INR at 12 hours. The ULD had fewer 12-hour INR values <2, with no statistical difference in the ΔINR at 12 hours between the ULD and SLD cohorts (median ΔINR, 2.2 [1.1, 3.4] vs 2.2 [1.1, 6.3]; P = 0.54; median INR, 2.3 vs 1.8). A total of 41 patients had both a 12- and 36-hour INR. No significant difference in the ΔINR between the 12- and 36-hour values occurred (median ΔINR, 0.52 [0.2, 0.91] vs ΔINR, 0.46 [0.18, 0.55]; P = 0.61), suggesting no rebound or excessive reversal and no difference in 30-day rates of VTE ( P > 0.99) or death ( P = 0.38). Conclusion and Relevance ULD IV vitamin K reversed INR similarly to doses of 1-2 mg without rebound. A ULD strategy may be considered in patients requiring more cautious reversal.

scholarly journals Complex Regional Pain Syndrome: Current Practice Management and Referral Trends in a Closed Healthcare System

Osteology ◽  
2020 ◽  
Vol 1 (1) ◽  
pp. 39-47
Author(s):  
Connor Zale ◽  
Joshua Hansen ◽  
Paul Ryan
Keyword(s):  
Pain Management ◽  
Pain Score ◽  
Complex Regional Pain Syndrome ◽  
Healthcare System ◽  
Pain Syndrome ◽  
Occupational Outcomes ◽  
Mean Delay ◽  
Significant Difference ◽  
The Mean ◽  
Over Time

Background: Complex regional pain syndrome (CRPS) is a neurologic condition that can present with severe pain and dysfunction. Delay in treatment adversely affects outcomes. The purpose of this study is to evaluate patient outcomes as they relate to the time from diagnosis to pain management referral once the diagnosis of CRPS has been made in a closed healthcare system. Methods: A retrospective record review from a closed healthcare system was utilized for CRPS cases from 2010–2019. Demographics, injury pattern, surgeries, pain score, treatment modalities, occupational outcomes, and time to pain management referral were recorded. Results: There were 26 cases of CRPS that met inclusion criteria. The mean time from diagnosis to treatment was 55 days. 16/26 (61.5%) were medically discharged from the military. 23/26 (88.5%) were unable to return to full duty due to CRPS. There was no significant difference in the reported pain scores over time regardless of treatment (p = 0.76). A linear regression demonstrated a significantly higher Visual Analog Scale Pain Score (VAS) over time in patients that were medically discharged (p = 0.022). Conclusions: The mean delay in referral to the pain service was 55 days. The majority of patients (88.5%) did not return to full duty secondary to the diagnosis of CRPS, and 61.5% of patients required medical separation from active duty. Due to the negative impact that the diagnosis of CRPS has on occupational outcomes with a mean delay in referral of 55 days, clinics and providers should set up referral criteria and establish early pain pathways for patients diagnosed with CRPS.

Factors associated with disability and pain intensity in patients with complex regional pain syndrome

2021 ◽  
pp. 1-9
Author(s):  
Maryam Farzad ◽  
Joy C. MacDermid ◽  
Tara Packham ◽  
Behzad Khodabandeh ◽  
Mohsen Vahedi ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Complex Regional Pain Syndrome ◽  
Pain Syndrome ◽  
Factors Associated

Are Illness Perceptions Associated with Pain and Disability in Complex Regional Pain Syndrome? A Cross-Sectional Study

Pain Medicine ◽  
2020 ◽  
Author(s):  
Dana R Antunovich ◽  
Juliette C Horne ◽  
Natalie L Tuck ◽  
Debbie J Bean
Keyword(s):  
Pain Intensity ◽  
Complex Regional Pain Syndrome ◽  
Psychological Factors ◽  
Illness Perceptions ◽  
Pain Syndrome ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Pain Disability ◽  
Regulation Model

Abstract Objective Complex regional pain syndrome (CRPS) is a complex and often poorly understood condition, and people with CRPS will have diverse beliefs about their symptoms. According to the self-regulation model, these beliefs (termed “illness perceptions”) influence health behaviors and outcomes. Previous studies have found that psychological factors influence CRPS outcomes, but few studies have investigated CRPS patients’ illness perceptions specifically. The present study examined whether illness perceptions were related to pain intensity and other relevant outcomes in people with CRPS. Methods In this cross-sectional study, 53 patients with CRPS (type 1 and type 2) completed questionnaires assessing illness perceptions, pain, disability, and psychological factors. Multiple regression analyses were used to determine whether illness perceptions were associated with pain intensity, disability, depression, and kinesiophobia, after controlling for possible covariates (including clinical and demographic factors, pain catastrophizing, and negative affect). Results Negative illness perceptions were associated with greater pain, disability, and kinesiophobia, but not depression. Specifically, attributing more symptoms to CRPS (more negative illness identity perceptions) was associated with greater pain intensity, and reporting a poorer understanding of CRPS (lower illness coherence scores) was associated with greater disability and kinesiophobia. Conclusions Patients with CRPS with more negative illness perceptions (particularly perceptions indicating a poor understanding of their condition) also experience greater pain, disability, and kinesiophobia. Future research could investigate whether altering CRPS patients’ illness perceptions influences clinical outcomes.

scholarly journals Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

2019 ◽  
Vol 79 (2) ◽  
pp. 276-284 ◽  
Author(s):  
Edward Roddy ◽  
Kris Clarkson ◽  
Milica Blagojevic-Bucknall ◽  
Rajnikant Mehta ◽  
Raymond Oppong ◽  
...  
Keyword(s):  
Primary Care ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Low Dose ◽  
Rating Scale ◽  
Randomised Trial ◽  
Pragmatic Trial ◽  
Open Label ◽  
Gout Flare ◽  
Gout Flares

ObjectivesTo compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.MethodsThis was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0–10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1–7 by intention to treat.ResultsBetween 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1–7 (colchicine vs naproxen: mean difference −0.18; 95% CI −0.53 to 0.17; p=0.32). During days 1–7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54).ConclusionWe found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications.Trial registration numberISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

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