A Phase 1 randomized, open-label clinical trial to evaluate the effect of a far-infrared emitting patch on local skin perfusion, microcirculation and oxygenation.

Far-infrared radiation (FIR) has been investigated for reduction of pain and improvement of dermal blood flow. The FIRTECH patch is a medical device designed to re-emit FIR radiated by the body. This phase 1 study was conducted to evaluate the local effects of the FIRTECH patch on local skin perfusion, microcirculation and oxygenation. This prospective, randomized, open-label, parallel designed study admitted 20 healthy participants to a medical research facility for treatment for 31 h on three anatomical locations. During treatment, imaging assessments consisting of laser speckle contrast imaging, near-infrared spectroscopy, side-stream dark-field microscopy, multispectral imaging and thermography were conducted regularly on patch-treated skin and contralateral non-treated skin. The primary endpoint was baseline perfusion increase during treatment on the upper back. Secondary endpoints included change in baseline perfusion, oxygen consumption and temperature of treated versus untreated areas. The primary endpoint was not statistically significantly different between treated and non-treated areas. The secondary endpoints baseline perfusion on the forearm (least square means [LSMs] difference 2.63 PU, 95% CI: 0.97, 4.28), oxygen consumption (LSMs difference: 0.42 arbitrary units [AUs], 95% CI: 0.04, 0.81) and skin temperature (LSMs difference 0.35°C, 95% CI: 0.16, 0.6) were statistically significantly higher in treated areas. Adverse events observed during the study were mild and transient. The vascular response to the FIRTECH patch was short-lived suggesting a non-thermal vasodilatory effect of the patch. The FIRTECH patch was well tolerated, with mild and transient adverse events observed during the study. These results support the therapeutic potential of FIR in future investigations.

Physical properties and biological effects of ceramic materials emitting infrared radiation for pain, muscular activity, and musculoskeletal conditions.

BACKGROUND: Up to 33% of the general population worldwide suffer musculoskeletal conditions, with low back pain being the single leading cause of disability globally. Multimodal therapeutic options are available to relieve the pain associated with muscular disorders, including physical, complementary, and pharmacological therapies. However, existing interventions are not disease modifying and have several limitations. METHOD: Literature review. RESULTS: In this context, the use of nonthermal infrared light delivered via patches, fabrics, and garments containing infrared-emitting bioceramic minerals have been investigated. Positive effects on muscular cells, muscular recovery, and reduced inflammation and pain have been reported both in preclinical and clinical studies. There are several hypotheses on how infrared may contribute to musculoskeletal pain relief, however, the full mechanism of action remains unclear. This article provides an overview of the physical characteristics of infrared radiation and its biological effects, focusing on those that could potentially explain the mechanism of action responsible for the relief of musculoskeletal pain. CONCLUSIONS: Based on the current evidence, the following pathways have been considered: upregulation of endothelial nitric oxide synthase, increase in nitric oxide bioavailability, anti-inflammatory effects, and reduction in oxidative stress.

Paracetamol Use in Patients With Osteoarthritis and Lower Back Pain: Infodemiology Study and Observational Analysis of Electronic Medical Record Data.

BACKGROUND: Lower back pain (LBP) and osteoarthritis (OA) are common musculoskeletal disorders and account for around 17.0% of years lived with disability worldwide; however, there is a lack of real-world data on these conditions. Paracetamol brands are frequently prescribed in France for musculoskeletal pain and include Doliprane, Dafalgan, and Ixprim (tramadol-paracetamol). OBJECTIVE: The objective of this retrospective study was to understand the journey of patients with LBP or OA when treated with paracetamol. METHODS: Three studies were undertaken. Two studies analyzed electronic medical records from general practitioners (GPs) and rheumatologists of patients with OA or LBP, who had received at least one paracetamol prescription between 2013 and 2018 in France. Data were extracted, anonymized, and stratified by gender, age, and provider specialty. The third study, an infodemiology study, analyzed associations between terms used on public medical forums and Twitter in France and the United States for OA only. RESULTS: In the first 2 studies, among patients with LBP (98,998), most (n=92,068, 93.0%) saw a GP, and Doliprane was a first-line therapy for 87.0% (n=86,128) of patients (71.0% [n=61,151] in combination with nonsteroidal anti-inflammatory drugs [NSAIDs] or opioids). Among patients with OA (99,997), most (n=84,997, 85.0%) saw a GP, and Doliprane was a first-line therapy for 83.0% (n=82,998) of patients (62.0% [n=51,459] in combination). Overall, paracetamol monotherapy prescriptions decreased as episodes increased. In the third study, in line with available literature, the data confirmed that the prevalence of OA increases with age (91.5% [212,875/232,650] above 41 years), OA is more predominant in females (46,530/232,650, 20.0%), and paracetamol use varies between GPs and rheumatologists. CONCLUSIONS: This health surveillance analysis provides a better understanding of the journey for patients with LBP or OA. These data confirmed that although paracetamol remains the most common first-line analgesic for patients with LBP and OA, usage varies among patients and health care specialists, and there are concerns over efficacy.

Self-Healing: A Concept for Musculoskeletal Body Pain Management - Scientific Evidence and Mode of Action.

Traditionally, musculoskeletal pain management has focused on the use of conventional treatments to relieve pain. However, multi-modal integrative medicine including alternative/complementary treatments is becoming more widely used and integrated into treatment guidelines around the world. The uptake of this approach varies according to country, with generally a higher uptake in developed countries and in females aged more than 40 years. Integral to the concept described here, is that the body has an innate ability to self-heal, which can be optimized by the use of integrative medical strategies. Stress triggers for acute or recurring musculoskeletal pain are diverse and can range from physical to psychological. The mechanism by which the body responds to triggers and initiates the self-healing processes is complex, but five body networks or processes are thought to be integral: the nervous system, microcirculation/vasodilation, immune modulation, muscular relaxation/contraction and psychological balance. Multi-modal integrative medicine approaches include nutritional/dietary modification, postural/muscular training exercises, and cognitive behavioral mind/body techniques. This article will review the self-healing concept and provide plausible scientific evidence where available.

Evaluating the Risk of Digitalis Intoxication Associated With Concomitant Use of Dronedarone and Digoxin Using Real-World Data.

PURPOSE: Dronedarone may increase digoxin plasma levels through inhibition of P-glycoprotein. Using real-world data, we evaluated the risk of digitalis intoxication in concomitant users of dronedarone and digoxin compared digoxin-alone users. METHODS: We used the Clinformatics DataMart, a US claims database, to identify adult patients with atrial fibrillation (AF) or atrial flutter (AFL) who concomitantly used dronedarone and digoxin and those who used digoxin alone between July 2009 and March 2016. Digitalis intoxication during follow-up until March 2016 was ascertained using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). Adjusted hazard ratios (HR) for digitalis intoxication in concomitant users versus users of digoxin alone were estimated, controlling for age, sex, cohort entry year, number of medical encounters for AF or AFL, history of congestive heart failure, diabetes, hypertension, stroke, myocardial infarction, renal failure, use of drugs interacting with digoxin, and digoxin dose. FINDINGS: Overall, 524 concomitant users and 32,459 users of digoxin alone were identified, among which 3 and 301 events of digitalis intoxication occurred during follow-up, respectively. Incidence rates were 17.25 and 9.17 cases per 1000 person-years, respectively. The adjusted HR for digitalis intoxication in concomitant users versus users of digoxin alone was 1.56 (95% CI, 0.50-4.88; P = 0.45). When digitalis intoxication was defined by ICD-9-CM and ICD-10-CM codes accompanied by laboratory testing for digoxin/digitoxin or hospitalization within 30 days, no events occurred in the concomitant users and 40 events occurred in the users of digoxin alone (incidence rate of 1.22 cases per 1000 person-years). IMPLICATIONS: Concomitant use of dronedarone and digoxin was uncommon in this study, and no significant increase in the risk of digitalis intoxication with concomitant use was found.

Assessing the Risk for Peripheral Neuropathy in Patients Treated With Dronedarone Compared With That in Other Antiarrhythmics.

PURPOSE: There are few data on the risk for peripheral neuropathy associated with dronedarone, a newer antiarrhythmic medicine. The objective of this study was to assess whether dronedarone is potentially associated with an increased risk for peripheral neuropathy compared with other antiarrhythmics, including amiodarone, sotalol, flecainide, and propafenone. METHODS: The MarketScan database was used for identifying patients who were at least 18 years of age, had atrial fibrillation or flutter, and had not been diagnosed with peripheral neuropathy in the 180-day period prior to or on the date of the first prescription of an antiarrhythmic between July 20, 2009, and December 31, 2011. Peripheral neuropathy that occurred during the treatment period for a study drug was ascertained using ICD-9-CM diagnostic codes. For each antiarrhythmic, the incidence rate of peripheral neuropathy was calculated. The adjusted hazard ratio (aHR) for peripheral neuropathy for dronedarone compared with another antiarrhythmic was obtained, with control for age, sex, diabetes mellitus status, and the presence of other comorbidities. FINDINGS: The study population included 106,933 patients treated with dronedarone (n = 12,989), amiodarone (n = 45,173), sotalol (n = 22,036), flecainide (n = 14,244), or propafenone (n = 12,491). The incidence rates (per 1000 person-years) of peripheral neuropathy were 1.33 for dronedarone, 2.38 for amiodarone, 1.20 for sotalol, 1.08 for flecainide, and 1.97 for propafenone. The aHRs for peripheral neuropathy for dronedarone relative to other drugs ranged from 0.53 (95% CI, 0.21-1.34) compared with propafenone, to 0.94 (95% CI, 0.38-2.30) compared with sotalol. A new-user analysis showed similar results. IMPLICATIONS: The risks for peripheral neuropathy were not significantly different between dronedarone and other antiarrhythmics.