Compounded Pain Formulations: What is the Evidence?

Pain syndromes are among the most widespread, costly, and debilitating of all neurological disorders. The number of patients living with chronic pain is expected to increase with the aging population and with the rise in obesity and diabetes across the nation. This type of pain is often insensitive to the traditional pain pharmacopeia or surgical intervention. Over the last 10 years the number of prescriptions that have been compounded by pharmacists has increased dramatically. There are a number of drugs in the area of pain management that have been formulated and compounded by pharmacists to treat conditions such as diabetic neuropathy, fibromyalgia, postherpetic neuralgia, joint pain, arthritis, and a variety of other conditions. A significant portion of these compounded analgesic preparations is made up of topical/transdermal dosage forms such as gels and creams. While the efficacy and doses of these drugs in systemic dosage forms have been widely established, little is known about the permeation and efficacy of these compounds from topical/transdermal gels. This review will provide an overview of chronic pain as a disease, the mechanisms of chronic pain, current treatment approaches to chronic pain, and a discussion of the drugs that are typically compounded into these topical formulations and studied in clinical trials.

Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial.

The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with mild/moderate ME/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists. The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6 months, with higher scores indicating better functioning. After 6 months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of -2.02 (95% confidence interval -7.75, 2.70). One hundred thirty-five participants completed the mean SF-36-PFS at 12 months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6 months, with the 12-month assessment, and the Spence Children's Anxiety scale being aligned with that finding. There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; p = 0.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.  Conclusion: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.  Trial registration: The study protocol was registered at www.isrctn.com (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.

Comparative Analysis of Psychophysiological Responses in Fibromyalgia Patients: Evaluating Neuromodulation Alone, Neuromodulation Combined with Virtual Reality, and Exercise Interventions.

BACKGROUND AND OBJECTIVES: Fibromyalgia, a chronic condition, manifests as widespread musculoskeletal pain, fatigue, sleep disturbances, autonomic and cognitive dysfunction, hypersensitivity to stimuli, and various somatic and psychiatric symptoms. This study, a controlled and randomized experiment, aimed to evaluate and compare the immediate effects of different treatments on fibromyalgia patients. MATERIALS AND METHODS: The treatments included the EXOPULSE Mollii suit, a combination of the EXOPULSE Mollii suit with a virtual reality (VR) protocol, and a physical exercise regimen. A cohort of 89 female fibromyalgia patients was randomly assigned to one of four groups: Control (n = 20), Suit only (n = 22), Suit combined with VR (n = 21), and Exercise (n = 26). RESULTS: This study found notable differences across the groups in several key parameters. In the Control group, significant changes were observed in Forced Expiratory Volume (FEV 1/FEV 6), the Numeric Rating Scale (NRS) for pain, Pressure Pain Threshold (PPT) at the epicondyle, cortical arousal levels, the 10 m up-and-go test, and in all measured variables related to temperature and muscle oxygenation. For the group using the suit alone, there were significant differences noted in the NRS, the chair stand test, palm temperature, and all muscle oxygenation parameters. The Suit + VR group showed significant changes in the NRS, PPT at the knee, handgrip strength test, the 10 m up-and-go test, one-leg balance test with the right leg, muscle oxygen saturation (SmO2), deoxygenated hemoglobin (HHb), and oxygenated hemoglobin (O2Hb). Finally, the Exercise group exhibited significant differences in FEV 1/FEV 6, chest perimeter difference, NRS, PPT at both the epicondyle and knee, cortical arousal, the chair stand test, the 10-m up-and-go test, and in SmO2, HHb, and O2Hb levels. CONCLUSIONS: combining neuromodulation with VR and targeted exercise regimens can effectively alleviate fibromyalgia symptoms, offering promising avenues for non-pharmacological management.

Efficacy of aquatic vs land-based therapy for pain management in women with fibromyalgia: a randomised controlled trial.

OBJECTIVE: To determine the efficacy of two physiotherapeutic interventions - aquatic therapy (AT) and land-based therapy (LBT) - for reducing pain in women with fibromyalgia. DESIGN: Single-blind, randomised controlled, equivalence trial. SETTING: Fibromyalgia, Chronic Fatigue Syndrome and Multiple Chemical Sensitivity Association in A Coruña, Spain. PARTICIPANTS: Forty women with fibromyalgia were assigned at random in a 1:1 manner to two groups: AT (n = 20) and LBT (n = 20). INTERVENTIONS: Two therapeutic exercise programmes, with 60-min sessions, were undertaken three times per week for 12 weeks. Sessions were carried out in groups by a trained physiotherapist. OUTCOME: The primary outcome was pain intensity (visual analogue scale). The secondary outcomes were pressure pain threshold (algometer), quality of life (Revised Fibromyalgia Impact Questionnaire), sleep quality (Pittsburgh Sleep Quality Index), fatigue (Multidimensional Fatigue Inventory) and physical ability (6-Minute Walk Test). Patients were evaluated at baseline, 12 weeks (post-treatment) and 18 weeks (follow-up). The statistical analysis was per-protocol. P < 0.05 was considered to indicate significance. Effect size was calculated. RESULTS: The mean age was 50 [standard deviation (SD) 9] years, with median body mass index of 27 [interquartile range (IQR) 25-30] kg/m2 and median symptom duration of 11 (IQR 6-15) years. No differences were observed between the groups post-treatment, but differences in favour of AT were found in pain intensity [2.7 (IQR 1.5-4.9) vs 5.5 (IQR 3.3-7.6); p= 0.023; large effect, Cohen's d= 0.8; 95% confidence interval (CI) 0.1-1.5] and sleep quality [12.0 (IQR 7.3-15.3) vs 15.0 (IQR 13.0-17.0); p= 0.030; large effect, Cohen's d= 0.8; 95% CI 0.1-1.5] at follow-up. CONCLUSIONS: The results suggest that AT is better than LBT for reducing pain intensity and improving sleep quality after 6 weeks of follow-up. AT may be a good treatment option for women with fibromyalgia. CLINICAL TRIALS REGISTRATION NUMBER: ClinicalTrials.gov NCT02695875 CONTRIBUTION OF THE PAPER.

Efficacy and Safety of Low Dose Naltrexone for Chronic Pain.

Naltrexone is a mu-opioid receptor antagonist increasingly used as an analgesic for chronic pain at low doses. This retrospective, observational cohort study was conducted at an academic medical center to evaluate low-dose naltrexone (LDN) efficacy and describe its use in routine clinical practice. Adults receiving LDN, doses <10 mg for ≥1 month, seen at an outpatient pain clinic from January 1, 2014 to April 1, 2022 were included. The primary outcome was change in the Pain, Enjoyment of Life, and General Activity (PEG) score after LDN. Thirty-one patients were included. Median age was 50 years and 71% were female. Median duration of pain at baseline was 5 years. Mean PEG scores were 7.27 ± 1.39 and 6.62 ± 2.04 at baseline and follow-up, respectively. Mean difference was 0.66 (95% CI [0.10-1.21], p = 0.022). Eighty-seven percent (27) of patients discontinued LDN, 52% (16) for lack of benefit, 23% (7) for loss of benefit, 10% (3) for side effects, and 3% (1) for other reasons. Seven (23%) reported side effects. LDN was associated with a statistically significant reduction in PEG in adult chronic pain patients, however the clinical significance is unclear as over 75% of patients discontinued LDN due to lack of benefit.

Opioids and fibromyalgia: frequency of use and factors associated with increased consumption in patients remitted to a tertiary care center.

BACKGROUND: Opioids are not recommended for fibromyalgia. OBJECTIVE: To investigate the frequency of opioid use in a large cohort of fibromyalgia patients and to identify factors associated with opioid consumption. METHODS: A retrospective, observational study of a large fibromyalgia cohort in a tertiary care center. We assessed fibromyalgia severity, functional capacity, anxiety, depression, drugs consumption and the patient's impression of change. We compared strong opioid consumers (SOC) and non-SOC. Inferential statistical and logistic regression analysis were used to identify factors associated with opioid consumption, and ANOVA for repeated measurements. RESULTS: We found a prevalence of 9.2% of SOC (100 patients) among 1087 patients in the cohort. During the last four years there was a significant increase on the incidence of SOC up to 12.8% (p = 0.004). There were no differences in demographic variables between SOC and non-SOC. Clinical variables were significantly more severe in SOC, and they consumed more non-opioid drugs (p < 0.0001). Opioid consumption was independently associated with other non-opioid drugs (Odds ratio 1.25, CI: 1.13-1.38), but not with the fibromyalgia severity. At three months, 62% of the patients had opioid withdrawal. There were no statistical differences in the fibromyalgia severity at the initial evaluation, or the patient's impression of change compared with those patients who continued opioids. Coping strategies were better in those patients who withdrew opioids (p = 0.044). CONCLUSIONS: We observed an increase in opioid prescriptions during the last four years. Opioid consumption was associated with concomitant use of non-opioid drugs, but it was not associated with fibromyalgia severity.

The crosstalk between subjective fibromyalgia, mental health symptoms and the use of over-the-counter analgesics in female Syrian refugees: a cross-sectional web-based study.

Suboptimal fibromyalgia management with over-the-counter analgesics leads to deteriorated outcomes for pain and mental health symptoms especially in low-income countries hosting refugees. To examine the association between the over-the-counter analgesics and the severity of fibromyalgia, depression, anxiety and PTSD symptoms in a cohort of Syrian refugees. This is a cross-sectional study. Fibromyalgia was assessed using the patient self-report survey for the assessment of fibromyalgia. Depression was measured using the Patient Health Questionnaire-9, insomnia severity was measured using the insomnia severity index (ISI-A), and PTSD was assessed using the Davidson trauma scale (DTS)-DSM-IV. Data were analyzed from 291. Among them, 221 (75.9%) reported using acetaminophen, 79 (27.1%) reported using non-steroidal anti-inflammatory drugs (NSAIDs), and 56 (19.2%) reported receiving a prescription for centrally acting medications (CAMs). Fibromyalgia screening was significantly associated with using NSAIDs (OR 3.03, 95% CI 1.58-5.80, p = 0.001). Severe depression was significantly associated with using NSAIDs (OR 2.07, 95% CI 2.18-3.81, p = 0.02) and CAMs (OR 2.74, 95% CI 1.30-5.76, p = 0.008). Severe insomnia was significantly associated with the use of CAMs (OR 3.90, 95% CI 2.04-5.61, p < 0.001). PTSD symptoms were associated with the use of CAMs (ß = 8.99, p = 0.001) and NSAIDs (ß = 10.39, p < 0.001). Improper analgesics are associated with poor fibromyalgia and mental health outcomes, prompt awareness efforts are required to address this challenge for the refugees and health care providers.

Effects of traditional Chinese exercises in fibromyalgia syndrome: A meta-analysis of randomized controlled trials.

OBJECTIVES: To explore the efficacy and safety of five traditional Chinese exercises (TCEs) in patients with fibromyalgia syndrome (FMS). METHODS: The PubMed, Embase, Scopus, ProQuest, Web of Science, Cochrane, CNKI, WanFang, and VIP databases were comprehensively searched for randomized controlled trials (RCTs) related to TCEs published from inception until February 2023. Standardized mean differences (SMD) and 95% confidence intervals (CI) were used to determine the combined effects of the intervention, and the Cochrane risk-of-bias assessment tool and Review 5.2 software were used to assess methodological quality. The data were extracted and analyzed by the Stata15.0 random effects model. RESULTS: Nineteen RCTs including 1315 participants were included in the analysis. The studies were found to be heterogeneous (I2 =86.2, P = 0.000), and thus a random effects model was used to combine the data. The results showed that traditional Chinese exercises had potentially beneficial effects on reducing pain (SMD =-0.66,95% CI [-1.08, -0.25], P = 0.002), improving sleep (SMD = -0.35,95% CI [-0.68,0. 01], P = 0.041) and relieving depression (SMD= -0.24,95% CI [-0.47, -0.02], P = 0.034) in FMS patients. However, no significant effects were found on improved quality of life (SMD =-0.20,95% CI [-0.48,0.09], P = 0.176). CONCLUSIONS: TCEs can improve pain, sleep quality and depression in patients with FMS and are safe. However, they do not improve the quality of life significantly. Further large-scale, high-quality, and multi-center RCTs are required to verify the efficacy of TCEs.

Effects of exercise-based interventions on inflammatory markers in patients with fibromyalgia: A systematic review and meta-analysis.

OBJECTIVES: The aim of the present review was (1) to determine the effects of exercise based-interventions (EBIs) on pro-inflammatory and anti-inflammatory biomarkers in patients with fibromyalgia (FM), and (2) to determine the most effective type (acute or maintained) and modality (aerobic, resistance, etc.). METHODS: A systematic search was conducted in various electronic databases to identify all the relevant studies: Medline (PubMed), PEDro, EBSCO and Google Scholar. Clinical trials assessing the effects of EBIs in patients with FM were selected. Methodological quality was evaluated by two independent investigators using the Cochrane Risk of Bias Tool. Qualitative analysis was based on the classification of the results into levels of evidence according to GRADE. RESULTS: Eleven studies were included. The meta-analysis showed a statistically significant decrease in proinflammatory biomarkers by EBIs with a large clinical effect in 19 comparisons (SMD: 1.74; 95 % CI: 0.85-2.62; p < 0.05), especially for IL8. The certainty of the evidence was low. The meta-analysis showed no statistically significant increase in anti-inflammatory biomarkers (IL10) by EBIs in 6 comparisons and very low certainty of evidence. Evidence was found for acute and maintained effects of exercise, with aerobic and aquatic exercise modalities showing better improvements than resistance exercise. CONCLUSIONS: EBIs are effective in inducing an immunomodulatory response in FM, characterized by decreased pro-inflammatory signaling. However, there was no evidence of an increase in anti-inflammatory biomarkers. These results should be interpreted with caution due to low certainty of evidence.

Low dose lofexidine for medically directed outpatient opioid tapering in adults with chronic pain: a prospective case series.

BACKGROUND: In adults with chronic pain, mild-to-moderate withdrawal symptoms during medically directed opioid tapering in the outpatient setting may not be accompanied by hypertension or tachycardia. This clinical scenario could limit the use of lofexidine at dosages reported in clinical trials of opioid withdrawal precipitated by abrupt opioid discontinuation. Thus, the primary aim of this prospective case series is to describe the use of low dose lofexidine for opioid withdrawal in patients with chronic pain undergoing medically directed opioid tapering in an outpatient setting. METHODS: Six patients (white 5, Latino 1) admitted to an outpatient interdisciplinary pain rehabilitation program met inclusion and exclusion criteria. Patients self-selected to undergo medically directed opioid tapering, and the medication the patients were prescribed upon admission was used in the taper schedule. Upon initiation of the opioid taper, patients received 0.18 mg of lofexidine every 6 hours. RESULTS: Five of the six patients were women, and the median morphine milligram equivalents at baseline were 36.9. The median taper duration was 15 days, and the median duration of lofexidine administration was 14 days. Withdrawal scores were mild throughout the taper in four patients, and two patients with fibromyalgia experienced single episodes of moderately severe withdrawal symptoms at the median morphine milligram equivalent midpoint of the taper. No hypotension or sustained bradycardia were observed, and no adverse effects related to lofexidine were reported. CONCLUSION: The observations from this prospective case series suggest that low-dose lofexidine may be a feasible adjunct medication to attenuate withdrawal symptoms in adults with chronic pain undergoing outpatient opioid tapering.

Continuous ketamine infusion for the management of opioid-induced hyperalgesia following amputation.

We discuss the use of an inpatient multi-day continuous intravenous ketamine infusion for the treatment of opioid-induced hyperalgesia (OIH) and high fentanyl requirements in the case of a patient with a background of fibromyalgia/central sensitisation syndrome who underwent a complicated post-operative course following a right below-knee amputation for high-grade myxoid fibrosarcoma. The patient was successfully tapered off a total fentanyl patch dose of 162 mcg/hour every 72 hours (morphine equivalent dose of 389 mg/day) to short-acting hydromorphone 2 mg orally two times per day as needed (equivalent of 8 mg morphine sustained-release twice per day) during a 2-week admission with only mild withdrawal symptoms. We discuss the pharmacology of ketamine and its possible application in the treatment of OIH.

Effects of traditional Chinese exercise therapy on pain scores, sleep quality, and anxiety-depression symptoms in fibromyalgia patients: a systematic review and meta-analysis.

OBJECTIVE: This study aims to assess the effectiveness of traditional Chinese exercise therapy in alleviating pain, improving sleep quality, and reducing symptoms of anxiety and depression among fibromyalgia patients. METHODS: We conducted a comprehensive search across various databases, including PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge, VIP database, and Wanfang, to identify randomized controlled trials (RCTs) examining the impact of Traditional Chinese Exercise (TCE) interventions on fibromyalgia. Two independent authors extracted data from the selected studies based on predefined inclusion and exclusion criteria. Meta-analyses were performed using RevMan 5.3. RESULTS: The analysis encompassed 15 RCTs, comprising 936 participants. The meta-analysis revealed that TCE significantly surpassed the control group in reducing pain scores for fibromyalgia patients, as evidenced by improvements in FIQ [MD = -3.30, 95% CI (- 5.37, - 0.69), z = 2.53, p = 0.01] and VAS [MD = -1.87, 95% CI (- 2.12, - 1.61), z = 6.98, p < 0.00001]. Additionally, TCE demonstrated notable enhancements in sleep quality (PSQI) [MD = -2.23, 95% CI (- 2.86, - 1.61), z = 6.98, p < 0.0001], as well as in alleviating symptoms of anxiety and depression [MD = - 0.59, 95% CI (- 0.80, - 0.39), z = 5.63, p < 0.0001]. CONCLUSION: Traditional Chinese Exercise (TCE) exhibits significant efficacy in ameliorating pain, enhancing sleep quality, and alleviating symptoms of anxiety and depression in fibromyalgia patients.

Exercises for fibromyalgia syndrome: what YouTube tells us as a source of information for patient and physician education.

OBJECTIVE: YouTube, a popular worldwide source to access health information online, may have an impact in enhancing exercise therapy for fibromyalgia patients. This study is aimed to investigate the quality and reliability of exercise videos prepared for fibromyalgia syndrome on YouTube. METHODS: A thorough search on YouTube using six search terms related to fibromyalgia treatment and exercise was conducted. The videos with content on exercises for fibromyalgia, acceptable audio-video quality, and are in English language were included, whereas duplicates were excluded from the analysis. Quality was determined using the Global Quality Scale (GQS) and JAMA system, and reliability using the mDISCERN criteria. RESULTS: Out of a total of 600 videos, 70 videos that met the inclusion criteria were included in the analysis. Physicians were found to produce content mostly in high and medium quality (%70.2), other medical professionals mostly in low and medium quality (93.8%), while non-medical users mostly in low quality (86.7%). Ninety percent of the videos targeted patients, while 10% targeted healthcare professionals as an audience, and the majority (93.7%) of videos targeting patients were of low and medium quality, as most (85.7%) of the videos targeting healthcare professionals were of high quality. CONCLUSION: YouTube can be used as a tool to increase exercise adherence in fibromyalgia patients, as it offers a wide range of content that is easily accessible and useful at times. To implement this tool, physicians need to upload more content online as they stand for pioneers of high-quality information dissemination on the internet. KeyPoints • This research emphasizes the need for high-quality online healthcare information which is accessed by a vast number of individuals and the implementations that effectively address and prevent the spread of misinformation. • Additionally, it presents suggestions for the future regarding the uploading of such content on the internet. • Physicians hold the key responsibility in ensuring the availability of high-quality online health content, thereby carrying significant implications for its overall impact.

Does the effect of cognitive behavior therapy for chronic fatigue syndrome (ME/CFS) vary by patient characteristics? A systematic review and individual patient data meta-analysis.

Debate is ongoing on the efficacy of cognitive behavior therapy (CBT) for myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). With an individual patient data (IPD) meta-analysis we investigated whether the effect of CBT varied by patient characteristics. These included post-exertional malaise (PEM), a central feature of ME/CFS according to many. We searched for randomized controlled trials similar with respect to comparison condition, outcomes and treatment-protocol. Moderation on fatigue severity (Checklist Individual Strength, subscale fatigue severity), functional impairment (Sickness Impact Profile-8) and physical functioning (Short Form-36, subscale physical functioning) was investigated using linear mixed model analyses and interaction tests. PROSPERO (CRD42022358245). Data from eight trials (n = 1298 patients) were pooled. CBT showed beneficial effects on fatigue severity (ß = -11.46, 95% CI -15.13 to -7.79); p < 0.001, functional impairment (ß = -448.40, 95% CI -625.58 to -271.23); p < 0.001; and physical functioning (ß = 9.64, 95% CI 3.30 to 15.98); p < 0.001. The effect of CBT on fatigue severity varied by age (pinteraction = 0.003), functional impairment (pinteraction = 0.045) and physical activity pattern (pinteraction = 0.027). Patients who were younger, reported less functional impairments and had a fluctuating activity pattern benefitted more. The effect on physical functioning varied by self-efficacy (pinteraction = 0.025), with patients with higher self-efficacy benefitting most. No other moderators were found. It can be concluded from this study that CBT for ME/CFS can lead to significant reductions of fatigue, functional impairment, and physical limitations. There is no indication patients meeting different case definitions or reporting additional symptoms benefit less from CBT. Our findings do not support recent guidelines in which evidence from studies not mandating PEM was downgraded.

Dropout From Exercise Interventions in Adults With Fibromyalgia: A Systematic Review and Meta-analysis.

OBJECTIVE: To meta-analyze the prevalence and predictors of dropout rates among adults with fibromyalgia participating in exercise randomized controlled trials (RCTs). DATA SOURCES: Two authors searched Embase, CINAHL, PsycARTICLES, and Medline up to 01/21/2023. STUDY SELECTION: We included RCTs of exercise interventions in people with fibromyalgia that reported dropout rates. DATA EXTRACTION: Dropout rates from exercise and control conditions and exerciser/participant, provider, and design/implementation related predictors. DATA SYNTHESIS: A random effects meta-analysis and meta-regression were conducted. In total, 89 RCTs involving 122 exercise arms in 3.702 people with fibromyalgia were included. The trim-and-fill-adjusted prevalence of dropout across all RCTs was 19.2% (95% CI=16.9%-21.8%), which is comparable with the dropout observed in control conditions with the trim-and-fill-adjusted odds ratio being 0.31 (95% CI=0.92-1.86, P=.44). Body mass index (R2=0.16, P=.03) and higher effect of illness (R2=0.20, P=.02) predicted higher dropout. The lowest dropout was observed in exergaming, compared with other exercise types (P=.014), and in lower-intensity exercises, compared with high intensity exercise (P=.03). No differences in dropout were observed for the frequency or duration of the exercise intervention. Continuous supervision by an exercise expert (eg, physiotherapist) resulted in the lowest dropout rates (P<.001). CONCLUSIONS: Exercise dropout in RCTs is comparable with control conditions, suggesting that exercise is a feasible and accepted treatment modality; however, interventions are ideally supervised by an expert (eg, physiotherapist) to minimize the risk of dropout. Experts should consider a high BMI and the effect of the illness as risk factors for dropout.

Effectiveness of aquatic training based on aerobic and strengthening exercises in patients with fibromyalgia: systematic review with meta-analysis.

BACKGROUND AND PURPOSE: fibromyalgia is a chronic condition causing widespread pain, fatigue, limited physical function, and reduced quality of life. Aquatic training is recommended as a first-line non-pharmacological treatment. This study aims to evaluate the effectiveness of aquatic training based on aerobic and strengthening exercises in improving symptoms in women with fibromyalgia. MATERIAL AND METHODS: a systematic review with meta-analysis was conducted by searching the PubMed, Scopus, Cochrane Library and Web of Science databases. Randomized clinical trials that compared aquatic therapy with either a control group or a land-based exercise group were included. Study quality was assessed using the PEDro scale, the risk of bias was evaluated using the Cochrane Risk of Bias Tool, and the certainty of the evidence was assessed the GRADE guidelines. RESULTS: six randomized clinical trials comprising 9 publications showed that aquatic therapy had statistically significant benefits compared to no intervention, including pain, fatigue, fibromyalgia impact, depression, physical function, and mental health in the short term. In the medium term, improvements were observed in fibromyalgia impact, physical function, and mental health. However, aquatic therapy was not found to be superior to land-based exercise. CONCLUSION: low to very low certainty of evidence suggested that aquatic training may reduce pain, fibromyalgia impact, fatigue and depression and improve physical function and mental health in patients with fibromyalgia. Further studies should investigate the medium and long-term effects of aquatic training using larger sample sizes.

How to treat chronic pain in rheumatic and musculoskeletal diseases (RMDs) - A pharmacological review.

INTRODUCTION: Chronic pain is a common symptom of rheumatic diseases that impacts patients' quality of life. While non-pharmacological approaches are often recommended as first-line treatments, pharmacological interventions are important for pain management. However, the effectiveness and safety of different pharmacological treatments for chronic pain in rheumatic diseases are unclear. METHODS: This review critically synthesizes the current evidence base to guide clinicians in selecting appropriate pharmacological treatments for their patients, considering the expected benefits and potential risks and side effects. RESULTS: For osteoarthritis, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, opioids, and antidepressants are commonly used, with NSAIDs being the most recommended. In addition, topical agents, such as topical NSAIDs, are recommended for localized pain relief. For fibromyalgia, amitriptyline, serotonin and noradrenaline reuptake inhibitors (SNRIs), and gabapentinoids are commonly used, with SNRIs being the most recommended. For back pain, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, opioids are used only for acute of flare-up pain, whereas neuropathic pain drugs are only used for chronic radicular pain. For inflammatory rheumatic diseases, disease-modifying antirheumatic drugs (DMARDs) and biological agents are recommended to slow disease progression and manage symptoms. CONCLUSION: While DMARDs and biological agents are recommended for inflammatory rheumatic diseases, pharmacological treatments for other rheumatic diseases only alleviate symptoms and do not provide a cure for the underlying condition. The use of pharmacological treatments should be based on the expected benefits and evaluation of side effects, with non-pharmacological modalities also being considered, especially for fibromyalgia.

Effects of Nature-Based Multisensory Stimulation on Pain Mechanisms in Women with Fibromyalgia Syndrome: A Randomized Double-Blind Placebo-Controlled Trial.

BACKGROUND: The term "nature-based sensory stimuli" refers to the sensory information produced by biotic and abiotic agents from natural environments. The literature has reported the beneficial effects of these agents on various pain dimensions in non-clinical populations. AIMS: To evaluate the potential analgesic effects of nature-based multisensory stimulation in women with fibromyalgia syndrome. METHODS: A randomized, double-blind, placebo-controlled, parallel-group trial with a 1:1 allocation ratio was conducted. Forty-two women with fibromyalgia syndrome interacted with either different plant species with flowers, stones, and soil organic matter or their synthetic imitations for 30 minutes. Outcome measurements were performed before and after the intervention, including clinical pain intensity using the Numeric Rating Scale, cold pain thresholds using the Cold Pressor Test, mechanical hyperalgesia and wind-up using a monofilament, and pressure pain thresholds using a pressure algometer. RESULTS: Analyses revealed group × time interactions for clinical pain intensity (F = 7.915, p = .008), cold-water immersion time (F = 7.271, p = .010), mechanical hyperalgesia (F = 4.701, p = .036), and pressure pain threshold (p ≤ .017). Between-group differences were found in clinical pain intensity (p = .012), cold pain thresholds (p = .002), and pressure pain thresholds (p < .05). The experimental group exhibited reduced clinical pain intensity (p = .001) and increased pressure pain thresholds (p ≤ .034). CONCLUSIONS: Women with fibromyalgia syndrome may benefit from multisensory stimulation using biotic and abiotic agents from natural environments for 30 minutes. Interacting with flowering plants and soil components appears to induce analgesic effects.

Incidence and Prevalence of Pain Medication Prescriptions in Pathologies with a Potential for Chronic Pain.

BACKGROUND: Heightened risks of dependence, addiction, anxiolytic effects, or prescription overdose death due to long-term use of pain medication have increased awareness about extended pain medication use in chronic pain populations. The goal of this study was to evaluate the incidence and prevalence of pain medication prescriptions from 2012 to 2022 in common pathologies with a potential for chronic pain. METHODS: A retrospective cohort study was conducted using electronic health records from TriNetX (Cambridge, Massachusetts) Global Collaborative Network. For 10 distinct cohorts (total n = 9,357,584 patients), pain medication prescriptions were extracted for five classes, namely nonsteroidal anti-inflammatory drug (NSAIDs) and acetaminophen, opioids, gabapentinoids, neuropathic mood agents, and muscle relaxants. Annual incidence and prevalence of each class of medication were evaluated for the past 11 yr. RESULTS: From 2012 to 2022, there was a significant increase in prescriptions of NSAIDs, except for patients with fibromyalgia, and persistent spinal pain syndrome (PSPS) type 2. Interestingly, over time, prescriptions of opioids in patients with complex regional pain syndrome, endometriosis, osteoarthritis, and PSPS type 2 increased, as did prescriptions of muscle relaxants for all cohorts except those with fibromyalgia. Incidence of prescriptions of neuropathic mood agents is high for patients with complex regional pain syndrome (both types) and PSPS type 2. Only for benzodiazepines did there seem to be a decline over the years, with a significantly decreased time trend in patients with complex regional pain syndrome type 1, fibromyalgia, and PSPS type 2. CONCLUSIONS: During the last 11 yr, an increase in incidence of NSAIDs and acetaminophen, opioids, neuropathic agents, and muscle relaxants was observed. Only prescriptions of benzodiazepines significantly decreased over time in specific cohorts. Overall, patients with PSPS type 2 and complex regional pain syndrome (both types) consume a broad variety of pain medication classes.

Effectiveness of an online multicomponent program (FATIGUEWALK) for chronic fatigue syndrome: A randomized controlled trial.

OBJECTIVE: This study aimed to evaluate the effectiveness of an online multicomponent intervention called FATIGUEWALK (FaW) compared to treatment as usual (TAU) in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). METHOD: FaW included pain neuroscience education, therapeutic exercise, cognitive restructuring, and mindfulness training. A total of 428 patients with CFS/ME were randomized into two study arms: online FaW plus TAU versus TAU alone. A single-blinded randomized controlled trial was conducted. Validated patient-reported outcome measures of fatigue, pain, anxiety, depression, and physical function were collected at baseline and posttreatment, following the FaW intervention, which lasted 12 weeks. RESULTS: Statistically significant improvements (with small-to-moderate effect sizes) were observed in online FaW versus TAU alone with respect to multidimensional aspects of fatigue (Cohen's d ranging from 0.25 to 0.73) and most secondary outcomes (pain and fatigue intensity, depressive and anxious symptomatology, functional impairment, kinesiophobia, physical functioning). The absolute risk reduction in FaW versus TAU was 19%, 95% confidence interval (CI) [12.19, 25.80] with number needed to treat = 6, 95% CI [3.9, 8.2]. Overall, similar clinical improvements were observed in sensitivity analyses including a subgroup of patients without comorbidity with fibromyalgia (n = 70). CONCLUSIONS: This is the first study to assess the short-term effectiveness of an online multicomponent intervention added to TAU, compared to TAU alone, for the management of CFS/ME. Further trials, including active control groups with an equivalent treatment dose, and assessing the long-term effectiveness of the online FaW, are warranted. (PsycInfo Database Record (c) 2024 APA, all rights reserved).