Abstract:
Background:Many aspects of study conduct impact the observed effect size of treatment. Data were utilized from a recently published meta-analysis of randomized, double-blind, placebo-controlled, clinical trials performed for the United States Food and Drug Administration (FDA) approval of full mu-agonist opioids for the treatment of chronic pain. Methods:The number of study sites in each clinical trial and standardized effect size (SES) were extracted and computed. Standardized effect size was plotted against number of sites, and a two-piece linear model was fit to the plot. Ten studies were included. Results:The SES decreased linearly by 0.13 units for every 10 sites (p=0.037), from 0.75 to 0.36, until an inflection point of 60 sites, after which SES did not decline further. The total number of subjects required for 90% power to discriminate drug from placebo increased from 78 to 336 subjects going from 30 to 60 sites. Conclusion:Results showed that the number of sites was a source of loss of assay sensitivity in clinical trials, which may contribute to the well-known problem of failure to successfully transition from Phase 2 to Phase 3 clinical development. Potential solutions include minimizing the number of sites, more rigorous and validated training, central statistical monitoring with rapid correction of performance issues, and more rigorous subject and site selection.
journal_name
J Pain Resjournal_title
Journal of pain researchauthors
Meske DS,Vaughn BJ,Kopecky EA,Katz Ndoi
10.2147/JPR.S201751subject
Has Abstractpub_date
2019-11-20 00:00:00pages
3161-3165issn
1178-7090pii
201751journal_volume
12pub_type
杂志文章abstract::Advances in intrathecal analgesia and intrathecal drug delivery systems have allowed for a range of medications to be used in the control of pain and spasticity. This technique allows for reduced medication doses that can decrease the side effects typically associated with oral or parenteral drug delivery. Recent expe...
journal_title:Journal of pain research
pub_type: 杂志文章,评审
doi:10.2147/JPR.S37591
更新日期:2014-11-06 00:00:00
abstract:BACKGROUND:Sports-related injuries, such as sprains and strains, commonly occur during exercise and athletic events. Current therapy includes nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of upper gastrointestinal side effects. The present study assessed the efficacy and safety of the diclo...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S15380
更新日期:2011-03-07 00:00:00
abstract:PURPOSE:Conditioned pain modulation (CPM) is an experimental approach for probing endogenous analgesia by which one painful stimulus (the conditioning stimulus) may inhibit the perceived pain of a subsequent stimulus (the test stimulus). Animal studies suggest that CPM is mediated by a spino-bulbo-spinal loop using obj...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S65607
更新日期:2014-11-26 00:00:00
abstract:Background:Central post-stroke pain (CPSP) is refractory to pharmacotherapy (eg, NSAIDs, opioids, antidepressants, and anticonvulsants), and may require transcranial or deep brain stimulation. Case Presentation:A 67-year-old woman presented with severe paroxysmal cramp-like pain on the right side, including the head a...
journal_title:Journal of pain research
pub_type:
doi:10.2147/JPR.S236812
更新日期:2020-02-26 00:00:00
abstract:BACKGROUND:Even though pain is a subjective phenomenon, its objective evaluation in humans is important because subjects requiring pain evaluation may be unable to describe their pain intensity because of decreased awareness or impaired cognitive function. Previous reports indicate that the perfusion index (PI), which ...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S57140
更新日期:2014-02-10 00:00:00
abstract::Calcitonin gene-related peptide (CGRP) is a major player in migraine pathophysiology, and CGRP monoclonal antibodies including fremanezumab may be a safe effective preventive therapy. Phase IIb studies in episodic migraine (EM) and chronic migraine (CM) demonstrated efficacy at both the monthly 225 mg and quarterly 67...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S166427
更新日期:2019-08-22 00:00:00
abstract:Purpose:Primary dysmenorrhea (PD; menstrual pain without an identified organic cause) has been proposed as a possible risk factor for the development of chronic pelvic pain, but the mechanism through which this process occurs is unknown. One possible mechanism is central sensitization - alterations in the central nervo...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S283363
更新日期:2020-12-22 00:00:00
abstract:Purpose:Post-herpetic neuralgia (PHN) is a common herpes zoster (HZ) complication, where pain persists 90 days after the initial HZ diagnosis. Evaluating PHN risk is essential for determining the burden on patients and health-care systems, but research shows variable estimates. The extent to which these differences are...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S255238
更新日期:2020-07-13 00:00:00
abstract:Background:Previous studies have shown the efficacy of tapentadol (TP) for chronic cancer pain. We evaluated multiple effectiveness aspects of TP prolonged release on moderate-severe cancer-related pain, neuropathic pain (NeP), patient satisfaction, and quality of life. Methods:An observational prospective study was c...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S181079
更新日期:2018-12-24 00:00:00
abstract::This study describes the cultural adaptation and testing of the behavioral pain scale (BPS) and the critical-care pain observation tools (CPOT) for pain assessment in Taiwan. The cross-cultural adaptation followed the steps of translation, including forward translation, back-translation, evaluation of the translations...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S91036
更新日期:2016-09-15 00:00:00
abstract:BACKGROUND:It has been demonstrated that N-ethyl-lidocaine (QX-314) can target the transient receptor protein vanilloid 1 (TRPV1) nociceptors when coadministered with capsaicin, resulting in a selective block of the nociceptors. Capsaicin is problematic in therapeutic use because it induces firing of nociceptors. The p...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S41614
更新日期:2013-01-01 00:00:00
abstract:PURPOSE:This paper aimed to investigate motor proficiency in fine and gross motor function, with a focus on reaction time (RT) and movement skill, in patients with fibromyalgia (FM) and chronic fatigue syndrome (CFS) compared to healthy controls (HC). METHODS:A total of 60 individuals (20 CFS, 20 FM, and 20 HC), age 1...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S127038
更新日期:2017-02-07 00:00:00
abstract:Purpose:Pregabalin is indicated for postherpetic neuralgia (PHN) in multiple countries, including China. This analysis compared pregabalin efficacy and safety in Chinese and international patients with PHN. Patients and methods:Data from Chinese and international randomized, double-blind, placebo-controlled trials wer...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S157856
更新日期:2018-09-03 00:00:00
abstract::Purpose: One of the main factor of cervical foraminal stenosis (CFS) is the hypertrophic change of the cervical facet joint. In order to analyze the connection between CFS and the facet joint hypertrophy, we devised a new morphological parameter, called the cervical facet joint cross-sectional area (CFJA). The CFJA ha...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S204567
更新日期:2019-04-24 00:00:00
abstract::Pulsed radiofrequency is an effective, safe, and nondestructive pain treatment technique that has been insufficiently reported in the treatment of supraorbital neuralgia. We report the successful use of pulsed radiofrequency to alleviate acute severe supraorbital neuralgia in a post-craniotomy patient. A 52-year-old f...
journal_title:Journal of pain research
pub_type:
doi:10.2147/JPR.S166446
更新日期:2018-08-08 00:00:00
abstract::This open-label, phase 3b study (ClinicalTrials.gov Identifier: NCT00983073) evaluated the effectiveness, and tolerability of tapentadol for severe, chronic osteoarthritis knee pain that was inadequately managed with World Health Organization (WHO) Step I or II analgesics or co-analgesics, or that was not treated with...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S30540
更新日期:2012-01-01 00:00:00
abstract:Purpose:The upregulation of spinal NMDA receptor is a crucial mechanism in remifentanil-induced hyperalgesia (RIH). Wnt3a/β-catenin pathway plays an important role in neuropathic pain. We hypothesized that wnt3a inhibitor (iwp-2) could downregulate the expression of NR2B subunit in NMDA receptor, in order to relieve R...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S250663
更新日期:2020-05-19 00:00:00
abstract:Background:Postherpetic neuralgia (PHN) refers to pain which remains after the healing of rashes from herpes zoster. Previous literatures have shown that acupuncture has potential benefits for PHN, but evidence remains lacking. Thus, we have performed a systematic review and meta-analysis to identify the effectiveness ...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S199950
更新日期:2019-07-16 00:00:00
abstract:Purpose:This study aimed to review and pool the current literature on intra-articular ozone injection in knee osteoarthritis (OA) patients. Methods:A systematic review of three big databases was performed to identify all English-language randomized clinical trials (RCTs) that evaluated the efficacy of intra-articular ...
journal_title:Journal of pain research
pub_type: 杂志文章,评审
doi:10.2147/JPR.S175441
更新日期:2018-10-25 00:00:00
abstract:Background:Chronic shoulder pain (CSP) is a common disease causing pain and functional limitation, which is highly prevalent and has substantial negative effects on the quality of life. Acupuncture has gained popularity and has been accepted gradually by many countries because it can successfully treat patients with ch...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S152550
更新日期:2018-03-07 00:00:00
abstract:BACKGROUND:Diagnosis of fibromyalgia (FM), a chronic musculoskeletal condition characterized by widespread pain and a constellation of symptoms, remains challenging and is often delayed. METHODS:Random forest modeling of electronic medical records was used to identify variables that may facilitate earlier FM identific...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/jpr.s8256
更新日期:2015-06-10 00:00:00
abstract:INTRODUCTION:Although the majority of opioids in the US are prescribed by nonpain specialists, these providers often report inadequate training in chronic pain management and opioid prescribing. The extent of health care providers' knowledge of opioid prescribing for chronic pain has not been well established. The purp...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S98273
更新日期:2016-03-10 00:00:00
abstract:UNLABELLED:Postsurgical pain management remains a significant challenge. Liposome bupivacaine, as part of a multimodal analgesic regimen, has been shown to significantly reduce postsurgical opioid consumption, hospital length of stay (LOS), and hospitalization costs in gastrointestinal (GI) surgery, compared with intra...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S63764
更新日期:2014-06-24 00:00:00
abstract:Background and Aims:Plantar fasciitis (PF) is the leading cause of heel pain in adults. This study was designed to evaluate the effect of hyaluronic acid (HA) injection in reducing the symptoms of PF, compared with corticosteroid (CS) injection as a conventional treatment. Methods:In this triple-blind, randomized, cli...
journal_title:Journal of pain research
pub_type:
doi:10.2147/JPR.S217419
更新日期:2020-01-14 00:00:00
abstract:BACKGROUND:The objective of this study was to assess the safety, tolerability, and preliminary efficacy of NGX-4010, a capsaicin 8% patch, following pretreatment with three different topical anesthetics in patients with peripheral neuropathic pain. METHODS:This open-label, multicenter study enrolled 117 patients with ...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S25272
更新日期:2012-01-01 00:00:00
abstract:Background:This study evaluates the reporting quality of randomized controlled trials (RCTs) on acupuncture use for the treatment of postherpetic neuralgia and explores related factors. Methods:The following six databases PubMed, Embase, Cochrane Library, VIP, CNKI, and SinoMed, were systematically searched from their...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S210471
更新日期:2019-07-29 00:00:00
abstract:Objective:To describe the rate and demographics of pain among Vietnamese people in 48 provinces and describe the impact of pain on individuals, levels of satisfaction with treatment results, and behavior of pain sufferers. Methods:The cross-sectional study was conducted in adults presenting to outpatient clinics throu...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S184713
更新日期:2019-02-25 00:00:00
abstract:BACKGROUND:Very few studies have discussed transforaminal endoscopic discectomy (TED) in the treatment of common peroneal nerve paralysis induced by lumbar disk herniation (LDH). This study aimed to evaluate the efficacy of TED in the treatment of LDH combined with common peroneal nerve paralysis. MATERIALS AND METHOD...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S120463
更新日期:2017-01-05 00:00:00
abstract::Purpose: The study aimed to evaluate the analgesic efficiency of dexmedetomidine (DEX) when added to levobupivacaine in continuous ultrasound-guided serratus anterior plane block (SAPB) performed at the end of major thoracic surgery. Methods: This randomized, double-blind trial included 50 adults undergoing thoracic s...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S195431
更新日期:2019-04-30 00:00:00
abstract::Background: Chronic neuropathic pain (NP) is a complex disease that results from damage or presumed damage to the somatosensory nervous system. Current treatment regimens are often ineffective. The major impediment in developing effective treatments is our limited understanding of the underlying mechanisms. Preclinica...
journal_title:Journal of pain research
pub_type: 杂志文章
doi:10.2147/JPR.S209657
更新日期:2019-08-02 00:00:00