Effects of a low-pressure hyperbaric oxygen therapy on psychological constructs related to pain and quality of life in women with fibromyalgia: A randomized clinical trial.

BACKGROUND AND OBJECTIVES: Self-reported psychological variables related to pain have been posited as the major contributors to the quality of life of fibromyalgia (FM) women and should be considered when implementing therapeutic strategies among this population. The aim of this study was to explore the effect of low-pressure hyperbaric oxygen therapy (HBOT) on psychological constructs related to pain (i.e., pain catastrophism, pain acceptance, pain inflexibility, mental defeat) and quality of life in women with FM. METHODS: This was a randomized controlled trial. Thirty-three women with FM were randomly allocated to a low-pressure hyperbaric oxygen therapy group (HBOTG) (n=17), who received an 8-week intervention (5 sessions per week), and a control group (CG) (n=16). All women were assessed at baseline (T0) and upon completion of the study (T1) for self-perceived pain intensity, pain catastrophism, pain acceptance, pain inflexibility, mental defeat and quality of life. RESULTS: At T1, the HBOTG improved across all variables related to pain (i.e. self-perceived pain intensity, pain catastrophism, pain acceptance, pain flexibility, mental defeat) (p<0.05) and quality of life (p<0.05). In contrast, the CG showed no improvements in any variable. Furthermore, significant differences between the groups were found in quality of life (p<0.05) after the intervention. CONCLUSIONS: HBOT is effective at improving the psychological constructs related to pain (i.e. pain catastrophism, pain acceptance, pain flexibility, mental defeat) and quality of life among women with FM. Clinical Trial Link Clinical Trials gov identifier (NCT03801109).

Effect of exposure-based vs traditional cognitive behavior therapy for fibromyalgia: a two-site single-blind randomized controlled trial.

ABSTRACT: Fibromyalgia is a debilitating pain condition for which treatment effects are typically modest. The most evaluated psychological treatment is traditional cognitive behavior therapy (T-CBT), but promising effects have recently been seen in exposure-based cognitive behavior therapy (Exp-CBT). We investigated whether Exp-CBT was superior to T-CBT in a randomized controlled trial. Self-referred participants with fibromyalgia (N = 274) were randomized (1:1) to 10 weeks of Exp-CBT or T-CBT. Treatments were delivered online and presented as "CBT for fibromyalgia." Participants were assessed at baseline, weekly during treatment, posttreatment, and at 6- and 12-month follow-up. Primary outcome was the difference in reduction in fibromyalgia severity as measured using the Fibromyalgia Impact Questionnaire (FIQ) over 11 assessment points from baseline to posttreatment, modelled within an intention-to-treat framework using linear mixed effects models fitted on multiple imputed data. Approximately 91% of weekly FIQ scores were collected over the main phase. There was no significant difference between Exp-CBT and T-CBT in the mean reduction of fibromyalgia severity from pretreatment to posttreatment (b = 1.3, 95% CI -3.0 to 5.7, P = 0.544, d = -0.10). Minimal clinically important improvement was seen 60% in Exp-CBT vs 59% in T-CBT. Effects were sustained up to 12 months posttreatment. This well-powered randomized trial indicated that Exp-CBT was not superior to T-CBT for fibromyalgia. Both treatments were associated with a marked reduction in fibromyalgia severity, and the online treatment format might be of high clinical utility. T-CBT can still be regarded a reference standard treatment that remains clinically relevant when compared to novel treatment approaches.

What Concept of Manual Therapy Is More Effective to Improve Health Status in Women with Fibromyalgia Syndrome? A Study Protocol with Preliminary Results.

BACKGROUND: Fibromyalgia (FM) is defined as a chronic syndrome characterized by diffuse musculoskeletal pain, associated with characteristic signs and symptoms such as fatigue and/or sleep and mood disorders, and whose etiology, pathogenesis and prognosis may or may not be known. There is growing evidence of manual therapy as a treatment for pain in the short and medium term, also in patients affected by FM. However, the heterogeneity of the manual therapy treatments administered are a very common clinical practice, as they are based more on the judgment or tendency of the physiotherapist, rather than on clear scientific evidence. Therefore, the aim of the present study protocol will be to determine which manual therapy approach is more effective in addressing health status by improving symptoms (sensory, cognitive, emotional and social) in patients with FM. METHODS: a randomized controlled clinical trial with a 3-month follow-up will be carried out with 52 female patients affected by rheumatologist-diagnosed FM will be recruited and evaluated at the Asociación de Fibromialgia y Síndrome de Fatiga Crónica (AFINSYFACRO) in Móstoles, Madrid, Spain. For more details on the protocol, a pilot study was carried out using a non-probability method of judgmental or purposive sampling. Thirteen patients were also evaluated, treated and reevaluated; eight patients were assigned to the myofascial techniques approach (MTA) group and five to the Maitland's mobilization approach (MMA) group. RESULTS: the preliminary results presented here are intended to show how the planned randomized controlled clinical trial will develop. Patients who received MTA had significantly improved pain and health status outcomes after treatment and at 1-month follow-up, with no significant change in those who received MMA. CONCLUSIONS: the exact details of the study protocol on which the manual therapy approach is more effective in addressing health status by improving symptoms (sensory, cognitive, emotional, and social) in patients with FM are presented. Preliminary results show that manual therapy is effective in improving pain and health status in patients with fibromyalgia at short and medium term, with significant results in those who received MTA.

The role of cannabis in treatment-resistant fibromyalgia women.

BACKGROUND: Fibromyalgia is a complex pain-focused syndrome. Previous studies showed that Cannabis is efficacious in promoting sleep, deepening and lengthening the sleep cycle, and good pain relief (compared with the SSRIs and SNRIs). PURPOSE: This study aimed to use the World Health Organization Quality of Life Bref questionnaire (WhoQoL-bref) to characterize the impact of Cannabis Treatment initiation on the quality of life in women suffering from treatment-resistant fibromyalgia. METHODS: A prospective cohort study involving 30 women aged 18-70 years old diagnosed with fibromyalgia, exhausted pharmacological fibromyalgia treatment, and started Cannabis treatment. Pregnant women were excluded. WhoQoL-bref was filled before Cannabis treatment initiation and 1 month following treatment. RESULTS: Women's average age was 46 years (±5), with a poor general quality of life (1.47 ± 0.63), poor general health (1.47 ± 0.78), pain and discomfort, and dependence on medication (3.77 ± 1.3 and 3.07 ± 1.74, respectively) prior to Cannabis intervention. Cannabis treatment for 30 days showed a marked improvement in general quality of life (1.97 scores, p < 0.01), general health (1.83, p < 0.01), physical health (1.5, p < 0.01), and psychological domain (1.3, p < 0.01). Financial resources and home environment were not influenced by cannabis treatment (p = 0.07, p = 0.31, respectively). CONCLUSION: Results suggest a potentially significant role of Cannabis in treatment-resistant Fibromyalgia women. Early Cannabis treatment may result in a beneficial short-term effect on the quality of life through its influence on pain, sleep, and physical and psychological domains. Further studies are still indicated to understand this potential and its long-term beneficial impact.

Mindfulness as a Symptom Management Strategy for Fibromyalgia: An Integrative Review.

Introduction: Mindfulness Meditation is a complementary and alternative medicine (CAM) modality growing in popularity. Currently, mindfulness is under-studied regarding efficacy; however, it offers a potentially accessible way to contribute to symptom management in chronic pain conditions. The purpose of this integrative review was to examine the literature for the use of mindfulness as symptom management strategy for persons diagnosed with the chronic pain condition, fibromyalgia. Methods: Six scientific databases were searched, using various keywords. Inclusion criteria were: (a) fibromyalgia, (b) English language, (c) experimental research designs; (d) adults age ≥ 18 years, and (e) mindfulness. Results: Seven studies were reviewed. Most interventions were completed over several months in the form of multiple group sessions lasting several hours each. Evaluations of effectiveness varied by study, but variables most commonly demonstrating improvement from mindfulness were anxiety, depression, sleep-related symptoms, coping and perceived stress. Mechanisms by which these outcomes may have been mediated included increases in self-compassion and psychological flexibility. Discussion: There is insufficient evidence to recommend mindfulness as an effective way to manage all fibromyalgia symptoms; however, promise lies in its usefulness addressing mood- and sleep-related symptoms. We suggest that further, more rigorous, research is warranted.

The Effects of Mindfulness Interventions on Fibromyalgia in Adults aged 65 and Older: A Window to Effective Therapy.

Pain usually receives insufficient attention by individuals due to the misconception that pain is a natural consequence of aging. For persons aged 65 and older, a disease requiring further research is fibromyalgia, characterized by chronic pain without clear pathology. Mind-body therapies like mindfulness are beneficial for this population as they affect psychological and biological aspects of pain. These therapies emphasize a nonjudgmental acceptance of thoughts and attention to the experience without attempting to resist or change them. Despite the potential benefits of mindfulness interventions for persons with fibromyalgia aged 65 and older, only few studies have examined the effects of these therapies, yielding conflicting findings. Importantly, no study has yet to be conducted exclusively on this population. This comprehensive review examined existing literature focusing on the effects of mindfulness-based interventions on the physical and mental well-being of persons with fibromyalgia aged 65 and older. It highlights the need for further research on the relationship between mindfulness, fibromyalgia, and gerontology, calling for a standard protocol of intervention.

Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial.

BACKGROUND/OBJECTIVES: The aim of this study was to examine the effectiveness of two video-based multicomponent programs (FIBROWALK) and the Multicomponent Physiotherapy Program (MPP) for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only. We posit that FIBROWALK, due to inclusion of specific psychological ingredients (cognitive restructuring and mindfulness), can produce additional clinical benefits when compared to TAU or MPP alone. METHODS: A total of 330 patients with FM were recruited and randomly allocated (1:1:1) to TAU only, TAU + FIBROWALK, or TAU + MPP. FIBROWALK and MPP consisted of weekly videos on pain neuroscience education, therapeutic exercise and self-management patient education, but only the FIBROWALK intervention provided cognitive restructuring and mindfulness. Both programs were structurally equivalent. Between-group differences in functional impairment, pain, kinesiophobia, anxious-depressive symptoms and physical functioning were evaluated at post-treatment following Intention-To-Treat and complete-case approaches. RESULTS: Compared to TAU only, individuals in the FIBROWALK arm showed larger improvements in all clinical outcomes; similarly, participants in the MPP program also showed greater improvements in functional impairment, perceived pain, kinesiophobia, depressive symptoms compared to TAU only. The FIBROWALK intervention showed superior effects in improving pain, anxiety and depressive symptoms and physical functioning compared to MPP. CONCLUSIONS: This RCT supports the short-term effectiveness of the video-based multicomponent programs FIBROWALK and MPP for FM and provides evidence that cognitive-behavioural and mindfulness-based techniques can be clinically useful in the context of physiotherapeutic multicomponent treatment programs. TRIAL REGISTRATION NUMBER: NCT04571528.

Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia.

BACKGROUND: Fibromyalgia syndrome (FMS) is a leading cause of functional limitations and disability for which there is no cure. Positive psychological interventions for improving health have received increasing attention, but evidence of the feasibility, acceptability, and impact of such interventions in adult populations with FMS is limited. OBJECTIVES: To describe the rationale and design of a 5-week, online positive affect skills intervention, LARKSPUR: Lessons in Affect Regulation to Keep Stress and Pain UndeR control. METHODS: FMS participants (N = 90) will be randomized to one of two conditions: (1) LARKSPUR or (2) emotion reporting/attention control. LARKSPUR is an online multicomponent intervention that targets eight skills to help foster positive affect: (1) noticing positive events, (2) savoring positive events, (3) identifying personal strengths, (4) behavioral activation to set and work toward attainable goals, (5) mindfulness, (6) positive reappraisal, (7) gratitude, and (8) acts of kindness. The primary outcomes include feasibility (i.e., recruitment, retention, adherence) and acceptability (i.e., helpfulness, usability, satisfaction). Secondary outcomes include pain intensity and pain interference. SIGNIFICANCE: If feasibility and acceptability metrics are met and reductions in pain outcomes are achieved, we will undertake future efficacy and effectiveness trials of LARKSPUR among older adults with FMS. TRIAL REGISTRATION: NCT04869345.

Experiences of patients with fibromyalgia at a Finnish Health Centre: A qualitative study.

BACKGROUND: Fibromyalgia is a functional syndrome. Despite recent findings, there is still considerable uncertainty about its diagnostic process. OBJECTIVES: This study aimed to explore patients' experiences with fibromyalgia during the diagnostic process in primary health care. Moreover, we tried to determine how diagnostic consultation could be improved. METHODS: This study is based on data from patients with fibromyalgia in a primary health care study conducted in Nokia, Finland. Patients with fibromyalgia were identified from electronic medical records. Focus-group participants with fibromyalgia diagnoses were selected using a purposive sampling method to gather a maximum variation sample. Qualitative thematic analysis was used for the coded data from four focus-group discussions in 2018. A description of the coding tree was provided and researchers organised the codes. Finally, all researchers identified themes from the data. RESULTS: The main unifying entities were the uncertainty and contradictions fibromyalgia patients faced on several occasions. Physicians sometimes offered other diagnoses - like depression - as an explanation for the symptoms, or used repetitive tests to eliminate other possible diagnoses. Furthermore, patients expressed their wishes for a holistic, empathetic, and up-to-date approach to their symptoms. CONCLUSION: In our interviews, a good doctor-patient relationship and continuity of care were necessary, as were the physician's attitude and knowledge of fibromyalgia. Our findings also suggest avoiding repeated or unnecessary rule-out tests and the overdiagnosis of psychiatric disorders is necessary.

Effects of a motor imagery-based exercise protocol on chronic pain and emotional distress in patients with fibromyalgia syndrome: A pilot study.

BACKGROUND: Fibromyalgia (FM) is a chronic condition characterized by widespread muscular or musculoskeletal pain of at least 3 months' duration, occurring above and below the waist, on both sides of the body. OBJECTIVE: The aim of this study was to evaluate the effectiveness of a rehabilitation program based on motor imagery versus a conventional exercise program in FM in terms of pain, functional and psychological outcomes. METHODS: Twenty-nine female subjects were randomly assigned to a group receiving motor imagery-based rehabilitation (MIG) or to a control group (CG) performing conventional rehabilitation. Outcome assessments were performed before (T0) and after 10 sessions of treatment (T1) and at a 12-week follow-up (T2). Pain, function and psychological measurements were conducted by means of different questionnaires. RESULTS: Both treatments improved all outcomes at post-treatment (T1) and follow-up (T2). The MIG showed a significant improvement in anxiety disorder associated with FM with respect to the CG, as well as improvements in coping strategies. CONCLUSIONS: Rehabilitation treatment based on motor imagery showed a stronger effect on anxiety and coping behavior than traditional physiotherapy in patients with FM. Integrated psychological support would be desirable in this setting. Further research is needed to explore the aspects investigated in more depth.

Identifying mindfulness and acceptance as mediators between negative affect, functional disability and emotional distress in patients with fibromyalgia.

OBJECTIVES: Fibromyalgia (FM) is a prevalent disabling condition characterised by chronic widespread pain. It is considered a complex illness in which the prognosis is conditioned by affective and cognitive mediators still largely unknown in FM. To investigate the correlation between psychological variables (acceptance, negative affect, and mindfulness) and functional disability or physical impact, anxiety/depression symptoms and emotional distress, and also to evaluate the mediating role of acceptance and mindfulness between negative affect, physical impact, anxiety/depression and emotional distress in individuals with FM. METHODS: Two hundred and fifty-one patients with FM who met the 2010 ACR criteria were included and filled out validated self-reported screening measures. The study explored Pearson's correlation coefficients and multiple mediation using a Preacher and Hayes's computational software tool, including the indirect effect associated with the two mediators (mindfulness and acceptance). RESULTS: Functional disability or physical impact, anxiety/depression symptoms and emotional distress correlated positively with negative affect (r= 0.580) and negatively with acceptance and mindfulness (r= -0.579 and r= -0.471; all p-values <0.001), respectively. The mediation analyses showed that acceptance and mindfulness mediated the relationship between negative affect and dependent variables such as physical impact, anxiety/depression symptoms and distress. CONCLUSIONS: The findings highlight that mindfulness and acceptance have a significant indirect effect on physical impact, anxiety/depression and emotional distress when controlling for negative affect as an independent variable in the FM patients. Future investigation should replicate and extend these outcomes in other study populations to determine the mediating role of mindfulness and acceptance in FM.

Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness-in addition to treatment as usual-compared with treatment as usual only in patients with fibromyalgia. METHODS: This randomized controlled trial involved a total of 272 patients who were randomly assigned to either multicomponent treatment (n = 135) or treatment as usual (n = 137). The multicomponent treatment (2-hour weekly sessions) was delivered in groups of 20 participants. Treatment as usual was mainly based on pharmacological treatment according to the predominant symptoms. Data on functional impairment using the Revised Fibromyalgia Impact Questionnaire as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, 12 weeks, and, for the multicomponent group only, 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% Revised Fibromyalgia Impact Questionnaire reduction) and nonresponders also were analyzed, and the number needed to treat was computed. RESULTS: At posttreatment, significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found in functional impairment, pain, kinesiophobia, and physical function, whereas differences with a moderate size effect (Cohen d > 0.50 and <0.80) were found in fatigue, anxiety, and depressive symptoms. Nonresponders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI = 1.7-2.3). CONCLUSION: Compared with usual care, there was evidence of short-term (up to 3 months) positive effects of the multicomponent treatment for fibromyalgia. Some methodological shortcomings (eg, absence of follow-up in the control group and monitoring of treatment adherence, potential research allegiance) preclude robust conclusions regarding the proposed multicomponent program. IMPACT: Despite some methodological shortcomings in the design of this study, the multicomponent therapy FIBROWALK can be considered a novel and effective treatment for patients with fibromyalgia. Physical therapists should detect patients with clinically relevant depression levels prior to treatment because depression can buffer treatment effects. LAY SUMMARY: Fibromyalgia is prevalent and can be expensive to treat. This multicomponent treatment could significantly improve the core symptoms of fibromyalgia compared with usual treatment.

A qualitative study of risk and resilience in young adult women with a history of juvenile-onset fibromyalgia.

BACKGROUND: Juvenile-onset Fibromyalgia (JFM) is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep difficulties, mood concerns, and other associated symptoms. Although diagnosed in childhood, JFM often persists into adulthood can result in continued physical, social, and psychological impairment. The purpose of this qualitative study was to identify themes of risk and resilience for long-term outcomes among young adults diagnosed with JFM in childhood. METHODS: The sample included 13 young adults (ages 26-34) who had been diagnosed with JFM in adolescence. Focus groups were used to elicit qualitative information about living with JFM and perceived challenges and buffering factors impacting their adjustment. RESULTS: The majority of participants (80%, N = 12) continued to meet criteria for fibromyalgia (FM). An iterative, thematic analysis revealed themes of resilience (e.g., greater acceptance, re-setting expectations, active coping, addressing mental health) and risk (e.g., lack of information, stigma, isolation, negative healthcare experiences). CONCLUSION: Results suggest the need for longer follow-up of youth with JFM as they transition to adulthood with multidisciplinary care and more attention to education about JFM and associated symptoms such as fatigue, as well as ongoing support for coping and mental health needs. A holistic approach to care during the transition years could be beneficial to minimize impact of JFM on long-term functioning.

Serotonergic gene-to-gene interaction is associated with mood and GABA concentrations but not with pain-related cerebral processing in fibromyalgia subjects and healthy controls.

The neurotransmitter serotonin, involved in the regulation of pain and emotion, is critically regulated by the 5-HT1A autoreceptor and the serotonin transporter (5-HTT). Polymorphisms of these genes affect mood and endogenous pain modulation, both demonstrated to be altered in fibromyalgia subjects (FMS). Here, we tested the effects of genetic variants of the 5-HT1A receptor (CC/G-carriers) and 5-HTT (high/intermediate/low expression) on mood, pain sensitivity, cerebral processing of evoked pain (functional MRI) and concentrations of GABA and glutamate (MR spectroscopy) in rostral anterior cingulate cortex (rACC) and thalamus in FMS and healthy controls (HC). Interactions between serotonin-relevant genes were found in affective characteristics, with genetically inferred high serotonergic signalling (5-HT1A CC/5-HTThigh genotypes) being more favourable across groups. Additionally, 5-HT1A CC homozygotes displayed higher pain thresholds than G-carriers in HC but not in FMS. Cerebral processing of evoked pressure pain differed between groups in thalamus with HC showing more deactivation than FMS, but was not influenced by serotonin-relevant genotypes. In thalamus, we observed a 5-HT1A-by-5-HTT and group-by-5-HTT interaction in GABA concentrations, with the 5-HTT high expressing genotype differing between groups and 5-HT1A genotypes. No significant effects were seen for glutamate or in rACC. To our knowledge, this is the first report of this serotonergic gene-to-gene interaction associated with mood, both among FMS (depression) and across groups (anxiety). Additionally, our findings provide evidence of an association between the serotonergic system and thalamic GABA concentrations, with individuals possessing genetically inferred high serotonergic signalling exhibiting the highest GABA concentrations, possibly enhancing GABAergic inhibitory effects via 5-HT.

Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double-blind randomized controlled exploratory and pragmatic trial.

BACKGROUND: Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological trauma. Therefore, a trauma-focused psychotherapy, such as eye movement desensitization and reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients and if its potential is boosted with the addition of MtCS. METHODS: Forty-five patients with FM and a history of traumatic events will be randomly allocated to Waiting List, EMDR + active-MtCS, or EMDR + sham-MtCS. Therapists and patients will be kept blind to MtCS conditions, and raters will be kept blind to both EMDR and MtCS. All patients will be evaluated at baseline, post-treatment, and follow-up at 6 months after post-treatment. Evaluations will assess the following variables: sociodemographic data, pain, psychological trauma, sleep disturbance, anxiety and affective symptoms, and wellbeing. DISCUSSION: This study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtCS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04084795 . Registered on 2 August 2019.

Posthypnotic Amnesia in Hypnotizability Assessment: Validation of a New Scoring System for the Hypnotic Induction Profile.

The Hypnotic Induction Profile (HIP) is a standardized assessment of hypnotizability featuring a validated 0-10 scoring system, that does not factor in posthypnotic amnesia. Using confirmatory factor analyses (CFA), we compared the 10-point scoring system with a new 12-point system that includes the posthypnotic amnesia item in independent samples of individuals with fibromyalgia (n = 98) and healthy adults (n = 97). Additionally, we explored associations of the two scoring systems with measures of hypnotic phenomena. CFA results indicate that the 12-point scoring system is a good fit for the 1-factor model of hypnotizability. Posthypnotic amnesia loaded highly on the model in the fibromyalgia sample, and moderately on the model in healthy adults. Furthermore, the 12-point scoring system correlated significantly with measures of hypnotic phenomena. We conclude that the 12-point scoring system is psychometrically equivalent yet conceptually more comprehensive than the 10-point scoring system.

Use of Complementary and Alternative Medicine in Fibromyalgia: Results of an Online Survey.

BACKGROUND: Fibromyalgia is a chronic condition which may negatively impact various aspects of patients' lives. Many people with fibromyalgia look to complementary and alternative medicine treatments for symptom relief. AIMS: The three main objectives of this study were to examine self-reported complementary and alternative medicine use in patients with fibromyalgia, to determine associations between the use of complementary and alternative medicine treatments and patients' self-reported quality of live and self-reported pain levels. DESIGN: Cross-sectional survey. SETTING: Web-based. PARTICIPANTS/SUBJECTS: Adults over the age of 18 years who had been diagnosed with fibromyalgia. METHODS: Patients with fibromyalgia responded to an online questionnaire regarding the following: treatments (complementary and alternative medicine, prescription and over-the-counter medications), quality of life (Quality of Life Scale-16), assessment of current pain (visual analog scale), and demographic information. RESULTS: Approximately 66% of the respondents used complementary and alternative treatments. Vitamins, massage therapy, and meditation were the most commonly used complementary and alternative therapies. Results indicated respondents using a combination of complementary and alternative medicine and pharmacologic treatments (prescription or over-the-counter) had significantly higher quality of life versus those using pharmacologic treatments alone, p = .011. Similarly, respondents using only complementary and alternative medicine treatment reported significantly lower pain levels versus those using pharmacologic treatment alone, p = .046. CONCLUSIONS: The study suggests that a large proportion of fibromyalgia patients use complementary and alternative medicine, and these treatments may offer beneficial effects to these patients. Integration of complementary and alternative medicine into conventional treatment regimens may provide opportunities for a holistic treatment approach and greater symptom relief for fibromyalgia patients. This approach is timely, as controlled substances are increasingly difficult for patients with fibromyalgia to access.

The Impact of a 20-Minute Animal-Assisted Activity Session on the Physiological and Emotional States in Patients With Fibromyalgia.

OBJECTIVE: To study the direct physiological and emotional impact of an animal-assisted activity (AAA) session (a form of complementary and integrative medicine) in patients with fibromyalgia (FM). PATIENTS AND METHODS: The study population consisted of 221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018. This was a randomized controlled trial. Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only). To gain a better understanding of the direct physiological and emotional effects of AAA in patients with FM, we used multiple noninvasive physiologic-emotional biomarkers, including salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters, in addition to standardized pain and mood-based questionnaires. RESULTS: Results show a decrease in heart rate, an increase in heart rate variability, an increase in well-being survey scores, an increase in salivary oxytocin, and subsequent tympanic membrane temperature changes, suggesting that participants in the treatment group were in a more positive emotional-physiologic state as a result of the AAA session compared with the control group. CONCLUSION: Our results suggest that a 20-minute therapy dog visit in an outpatient setting can significantly and positively impact the physical and mental health of patients with FM.

Feasibility and Acceptability of Heart Rate Variability Biofeedback in a Group of Veterans with Fibromyalgia.

Objectives: To determine the feasibility and acceptability of a heart rate variability biofeedback (HRVB) protocol in a focus group of Veterans with fibromyalgia (FM). Design: A multimethod feasibility and acceptability study. Settings/location: A Veterans Health outpatient pain medicine clinic in the southern United States. Subjects: The researcher enrolled seven women and three men between the ages of 33 and 68 years with a diagnosis of FM. Interventions: Participants practiced HRVB on the emWave2 at home for 20 min twice daily for 7 weeks. Outcome measures: Feasibility to adhere to the HRVB protocol was measured using the practice frequency and time (minutes) data collected from the emWave2. The author compared the individual reports from participants with the Credibility/Expectancy Questionnaire to measure the acceptability of the intervention. In addition, the principal investigator evaluated data from the Short-form McGill Pain Questionnaire (SFMQ) and the Revised Fibromyalgia Impact Questionnaire (FIQR) at the baseline and weekly study visits for a signal of efficacy for pain control, functional status, and quality of life (QOL). Results: The majority of participants (80%) expected 50% or more improvement in their pain, and (70%) felt HRVB would reduce their FM-related pain by 50%-80%. The mean daily practice frequency rate was 0.80. The mean practice duration was 19.36 min. Pain score differences from the SFMQ were insignificant preintervention and postintervention. The mean total FIQR scores postintervention improved by 18.1 points. Conclusions: Findings suggest twice-daily HRVB practice protocol is not feasible. However, 20-min HRVB sessions were feasible and acceptable. Improved FIQR scores post-treatment suggest HRVB may be an effective strategy to improve functional status and QOL for Veterans with FM. ClinicalTrials.gov ID: Pro00079144.

Psychotherapy for Physical Pain in Patients with Fibromyalgia: A Systematic Review.

Objective: To provide a brief and comprehensive summary of the recent evidence from clinical trials testing psychotherapeutic interventions in patients with fibromyalgia with particular interest in their possible effect on physical pain. Methods: Bibliographical search was performed in PubMed, PsycInfo, Web of Science, Scopus, and Cochrane Library databases. Content of the manuscripts was studied to obtain, if available, the following information: year of publication, location of the research team, design, type of psychotherapeutic intervention tested, pain measures, and a brief description of the psychotherapy, groups, and outcomes regarding physical pain. Results: Initial search eliciting 475 citations got reduced to 13 relevant papers. Most research studies from Spain (n = 8) are randomized control trials (n = 10) and used guided imagery (n = 5) or cognitive behavioral therapy (n = 4). The Visual Analogue Scale (n = 4) and the Fibromyalgia Impact Questionnaire (n = 4) were the physical pain measures mostly used. Improvements on physical pain were reported on all studies with published results; nevertheless, only in five cases, differences were significant. Conclusions: Evidence on the effect of psychotherapy on physical pain in patients with FS was divergent; though most studies report a reduction in pain, this was not always lasting and/or significant. Diversity of the results might be due to the selected psychotherapeutic approaches, assessment tools, and other internal (e.g., personality traits, (sub)clinical psychiatric symptoms, and treatment adherence) and external (e.g., family environment and social support) variables worth to be considered in the future research.