Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional Care In Patients Suffering From Fibromyalgia.

BACKGROUND: Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored. OBJECTIVES: To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM. METHODS: Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales. RESULTS: 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at both week 12 and 24. Improvement was higher for Fib-19-01 (-13.4 ± 18.9) than in the 2 other groups (-5.5 ± 15.6 and -5.6 ± 11.3) despite there was no statistical between-group difference at week 24 in FIQ score (P = .08 and P = .09 respectively). Analysis of variance in repeated measurements of FIQ showed a significant difference between Fib-19-01 and FS throughout the follow-up period (P = .03). Fib-19-01 was superior to both FS and NoST for Pichot scale decrease over time: -4.6 (range -6.9; -2.28), -0.29 (-2.7; 2.1) and -0.72 (-3.1; 1.66) (P = .013 and 0.023 respectively), mental and social SF12 [+8.1 (range 3.5; 12.6), -0.27(range -5.3; 4.8 ) and -0.02 (range -5.0; 4.9 ) P = .02 and 0.018)],HAD depression [-2.0 (range -3.3; -0.7), +0.5 (range -0.9; 1.9 ) and +0.71 (range -0.7; 2.1) P = .013 and 0.007]. No significant difference was found between FS and NoST groups for any outcome. All treatments were well and similarly tolerated. CONCLUSIONS: In patients with FM taking conventional therapy, Fib-19-01 has a therapeutic effect on fatigue, emotion and social life, and depression associated with the disease.

Mobile Health App and Web Platform (eDOL) for Medical Follow-Up of Patients With Chronic Pain: Cohort Study Involving the French eDOL National Cohort After 1 Year.

BACKGROUND: Chronic pain affects approximately 30% of the general population, severely degrades quality of life and professional life, and leads to additional health care costs. Moreover, the medical follow-up of patients with chronic pain remains complex and provides only fragmentary data on painful daily experiences. This situation makes the management of patients with chronic pain less than optimal and may partly explain the lack of effectiveness of current therapies. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs could better characterize patients, chronic pain, pain medications, and daily impact to help medical management. OBJECTIVE: This cohort study aimed to assess the ability of our mHealth tool (eDOL) to collect extensive real-life medical data from chronic pain patients after 1 year of use. The data collected in this way would provide new epidemiological and pathophysiological data on chronic pain. METHODS: A French national cohort of patients with chronic pain treated at 18 pain clinics has been established and followed up using mHealth tools. This cohort makes it possible to collect the determinants and repercussions of chronic pain and their evolutions in a real-life context, taking into account all environmental events likely to influence chronic pain. The patients were asked to complete several questionnaires, body schemes, and weekly meters, and were able to interact with a chatbot and use educational modules on chronic pain. Physicians could monitor their patients' progress in real time via an online platform. RESULTS: The cohort study included 1427 patients and analyzed 1178 patients. The eDOL tool was able to collect various sociodemographic data; specific data for characterizing pain disorders, including body scheme; data on comorbidities related to chronic pain and its psychological and overall impact on patients' quality of life; data on drug and nondrug therapeutics and their benefit-to-risk ratio; and medical or treatment history. Among the patients completing weekly meters, 49.4% (497/1007) continued to complete them after 3 months of follow-up, and the proportion stabilized at 39.3% (108/275) after 12 months of follow-up. Overall, despite a fairly high attrition rate over the follow-up period, the eDOL tool collected extensive data. This amount of data will increase over time and provide a significant volume of health data of interest for future research involving the epidemiology, care pathways, trajectories, medical management, sociodemographic characteristics, and other aspects of patients with chronic pain. CONCLUSIONS: This work demonstrates that the mHealth tool eDOL is able to generate a considerable volume of data concerning the determinants and repercussions of chronic pain and their evolutions in a real-life context. The eDOL tool can incorporate numerous parameters to ensure the detailed characterization of patients with chronic pain for future research and pain management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04880096; https://clinicaltrials.gov/ct2/show/NCT04880096.

[Opioid therapy for chronic noncancer pain: retrospective analysis of patients hospitalized for withdrawal]. / Opioïdes forts dans le traitement des douleurs chroniques non cancéreuses : analyse rétrospective de patients pris en charge pour un sevrage*

OBJECTIVE: The prescription of opioids for the treatment of chronic non-cancer pain (CNCP) is not recommended for all of them, and can expose the patients to a benefit/risk ratio unfavorable. The objective of this study was to evaluate the management of patients hospitalized at the centre for evaluation and treatment of pain for opioid withdrawal, their outcome during hospitalization. METHOD: This is a retrospective descriptive study. The medical record of each patient was consulted to identify relevant data (demographics, treatments at the entrance and discharge of hospitalization, comorbidities, rating scale of pain). RESULTS: During the study period (3 years), 53 patients (64% of women), with a median age of 52 years, were included. Pain was mainly back pain and neck pain (52%). Morphine (43%) and fentanyl (42%) were the most frequently used opioids. At admission, 62% of patients had a depressive state. At hospital discharge, withdrawal was total in 18 patients (34%) and a total improvement of pain was observed for 19% of them. CONCLUSION: In this study, 57% of patients received, at admission to hospital, an opioid other than morphine in the treatment of CNCP. The management of pain offered by the pain clinic led to a total or partial opioid withdrawal in 94% of patients.

Safety and efficacy of an equimolar mixture of oxygen and nitrous oxide: a randomized controlled trial in patients with peripheral neuropathic pain.

ABSTRACT: Nitrous oxide (N2O) is an odorless and colorless gas routinely used as an adjuvant of anesthesia and for short-duration analgesia in various clinical settings mostly in the form of an N2O/O2 50%-50% equimolar mixture (EMONO). Experimental studies have suggested that EMONO could also induce long-lasting analgesic effects related to the blockade of N-methyl-D-aspartate receptors. We designed the first international multicenter proof of concept randomized, placebo-controlled study to assess the efficacy and safety of a 1-hour administration of EMONO or placebo (medical air) on 3 consecutive days up to 1 month after the last administration in patients with chronic peripheral neuropathic pain. A total of 240 patients were recruited in 22 centers in France and Germany and randomly assigned to 1 study group (120 per group). Average pain intensity (primary outcome), neuropathic pain characteristics (Neuropathic Pain Symptom Inventory), Patient Global Impression of Change, anxiety, depression, and quality of life were systematically assessed before and after treatment. The changes in average pain intensity between baseline and 7 days after the last administration were not significantly different between the 2 groups. However, evoked pain intensity (predefined secondary endpoint) and Patient Global Impression of Change (exploratory endpoint) were significantly improved in the EMONO group, and these effects were maintained up to 4 weeks after the last treatment administration. Mostly transient side effects were reported during the treatment administration. These encouraging results provide a basis for further investigation of the long-term analgesic effects of EMONO in patients with neuropathic pain.

High Prevalence of Misuse of Prescribed Opioid Analgesics in Patients with Chronic Non-Cancer Pain.

Opioid analgesic misuse by patients with chronic non-cancer pain is increasing in Western countries. To determine the extent of opioid misuse by patients with chronic non-cancer pain followed at a French pain management clinic. A questionnaire on pain (severity, causes and management) and opioid misuse (based on the 11 DSM-V criteria for substance abuse disorders) was administered by a health professional to patients during a short hospitalization. During the study period (September 1, 2015 to March 31, 2016), 52 patients (73.1% women; median age = 50 years [IQR25-75: 43-57]) responded to the questionnaire. Chronic pain was caused by fibromyalgia in 55.6% of patients, and was mainly classified as neurogenic (32.6%), nociceptive (30.4%), and psychosomatic (15.2%). At hospitalization, the median pain visual analog scale score was 7/10 [IQR25-75: 6-8], despite the ongoing treatment. The opioid misuse evaluation suggested the presence of misuse in 76.9% of patients (≥2 DSM-V criteria) that was severe in 52% of patients (≥6 DSM-V criteria). Our data highlight the high prevalence of misuse of prescribed opioids by adults with chronic non-cancer pain. A consultation with an addiction specialist should be included in the management of such patients.

Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4).

Few studies have directly compared the clinical features of neuropathic and non-neuropathic pains. For this purpose, the French Neuropathic Pain Group developed a clinician-administered questionnaire named DN4 consisting of both sensory descriptors and signs related to bedside sensory examination. This questionnaire was used in a prospective study of 160 patients presenting with pain associated with a definite neurological or somatic lesion. The most common aetiologies of nervous lesions (n=89) were traumatic nerve injury, post herpetic neuralgia and post stroke pain. Non-neurological lesions (n=71) were represented by osteoarthritis, inflammatory arthropathies and mechanical low back pain. Each patient was seen independently by two experts in order to confirm the diagnosis of neuropathic or non-neuropathic pain. The prevalence of pain descriptors and sensory dysfunctions were systematically compared in the two groups of patients. The analysis of the psychometric properties of the DN4 questionnaire included: face validity, inter-rater reliability, factor analysis and logistic regression to identify the discriminant properties of items or combinations of items for the diagnosis of neuropathic pain. We found that a relatively small number of items are sufficient to discriminate neuropathic pain. The 10-item questionnaire developed in the present study constitutes a new diagnostic instrument, which might be helpful both in clinical research and daily practice.

The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial.

OBJECTIVE: A music intervention method in the management of pain was recently developed while taking account of recommendations in the scientific literature. The objective of this study was to assess the usefulness of this music intervention to the management of patients with chronic pain. METHODS: A controlled, single-blind, randomized trial was used. Eighty-seven patients presenting with lumbar pain, fibromyalgia, inflammatory disease, or neurological disease were included in the study. During their hospitalization, the intervention arm (n=44) received at least 2 daily sessions of music listening between D0 and D10, associated with their standard treatment, and then pursued the music intervention at home until D60 using a multimedia player in which the music listening software program had been installed. The control arm received standard treatment only (n=43). The end points measured at D0, D10, D60, and D90 were: pain (VAS), anxiety-depression (HAD) and the consumption of medication. RESULTS: At D60 in the music intervention arm, this technique enabled a more significant reduction (P<0.001) in pain (6.3 ± 1.7 at D0 vs. 3 ± 1.7 at D60) when compared with the arm without music intervention (6.2 ± 1.5 at D0 vs. 4.6 ± 1.7 at D60). In addition, music intervention contributed to significantly reducing both anxiety/depression and the consumption of anxiolytic agents. DISCUSSION: These results confirm the value of music intervention to the management of chronic pain and anxiety/depression. This music intervention method appears to be useful in managing chronic pain as it enables a significant reduction in the consumption of medication.