The journal of pain : official journal of the American Pain Society
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The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). ⋯ Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. PERSPECTIVE: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry.
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Comparative Study
Sensitivities to Thermal and Mechanical Stimuli: Adults with Sickle Cell Disease Compared to Healthy, Pain-free African American Controls.
Evidence supports, but is inconclusive that sensitization contributes to chronic pain in some adults with sickle cell disease (SCD). We determined the prevalence of pain sensitization among adults with SCD pain compared with pain-free healthy adults. In a cross sectional, single session study of 186 African American outpatients with SCD pain (age 18-74 years, 59% female) and 124 healthy age, gender, and race matched control subjects (age 18-69 years, 49% female), we compared responses to standard thermal (Medoc TSA II) and mechanical stimuli (von Frey filaments). ⋯ Findings indicate that persistent allodynia and hyperalgesia can be part of the SCD pain experience and should be considered when selecting therapies for SCD pain. PERSPECTIVE: Compared with matched healthy controls, quantitative sensory testing in adults with pain and sickle cell disease (SCD) demonstrates higher prevalence of sensitization, including central sensitization. The findings of allodynia and hyperalgesia may indicate neuropathic pain and could contribute to a paradigm shift in assessment and treatment of SCD pain.
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The opioid crisis has highlighted the importance of improving patients' access to behavioral treatments for chronic pain and addiction. What is not known is if patients are interested in receiving these treatments. In this cross-sectional study, over 1,000 participants with chronic pain were surveyed using an anonymous online questionnaire on Amazon Mechanical Turk to investigate participants' use of and interest in pharmacological and behavioral treatments for chronic pain and addiction. ⋯ Results also suggest that patients endorsing behaviors consistent with opioid misuse are interested in behavioral treatments. PERSPECTIVE: This study provides information around chronic pain patients' treatment interests, treatment receipt, and recommendation receipt for behavioral pain management and addiction treatment. This study could help facilitate communication between patients and doctors regarding available treatments for chronic pain and pain treatment-related addiction problems.
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Review Meta Analysis
Cupping for patients with chronic pain: a systematic review and meta-analysis.
There is a growing interest in nonpharmacological pain treatment options such as cupping. This meta-analysis aimed to assess the effectiveness and safety of cupping in chronic pain. PubMed, Cochrane Library, and Scopus were searched through November 2018 for randomized controlled trials on effects of cupping on pain intensity and disability in patients with chronic pain. ⋯ Perspective: This article presents the results of a meta-analysis aimed to assess the effectiveness and safety of cupping with chronic pain. The results suggest that cupping might be a treatment option; however, the evidence is still limited due to methodical limitations of the included trials. High-quality trials seem warranted.
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Randomized Controlled Trial Multicenter Study
Evolution of Analgesic Tolerance and Opioid-Induced Hyperalgesia over 6 months: Double-blind randomized trial incorporating experimental pain models.
Contributors to the ongoing epidemic of prescription opioid abuse, addiction, and death include opioid tolerance, withdrawal symptoms, and possibly opioid-induced hyperalgesia (OIH). Thirty stable chronic nonmalignant pain patients entered a 6-month long, randomized, double-blind, dose-response, 2-center trial of the potent opioid levorphanol, conducted over a decade ago during an era of permissive opioid prescribing. Eleven were taking no opioids at study entry and eleven were taking between 35 and 122 morphine equivalents. ⋯ TRIAL REGISTRATION: NCT00275249 Evolution of Analgesic Tolerance With Opioids PERSPECTIVE: A double-blind, 6-month, high-dose opioid feasibility trial, completed years ago, provides critically important data for clinically defining analgesic tolerance and OIH. Overall benefit was small, and 18% of patients had evidence of both tolerance and OIH. Future work requires a different approach than a classic randomized controlled trial design.