Severe fibromyalgia alleviated by the unique muscle relaxation method of applying low force: A case report.

RATIONALE: Fibromyalgia (FM) is characterized by idiopathic persistent chronic pain in the ligaments or musculoskeletal system, and more than half of the patients with FM might have migraine headaches. Direct musculoskeletal intervention could be a non-pharmacological management to relieve symptoms. However, patients with severe FM often have intense pain from only a soft touch, thereby rendering musculoskeletal intervention challenging. PATIENT CONCERNS: A 47-year-old man had progressing intense pain, and this affected his everyday life. There were no abnormal physical findings on laboratory examination such as levels of complement, antinuclear antibodies, and C-reactive protein, which were within normal limits. Magnetic resonance imaging did not indicate abnormalities. DIAGNOSES, INTERVENTIONS, AND OUTCOMES: The patient satisfied the American College of Rheumatology criteria. Finally, we made a final diagnosis of fibromyalgia. The therapeutic intervention of Kanshoho, the unique muscle relaxation technique with low force, relieved his pain. LESSONS: If Kanshoho is carefully applied in a state of hospitalization under surveillance by an experienced physician, it could be a promising muscle relaxation method. Relaxing the trapezius muscle and reducing its intramuscular pressure might be key in treating patients with severe FM. However, it needs elucidation of its mechanism.

The effect of vitamin D treatment on quality of life in patients with fibromyalgia.

BACKGROUND: Fibromyalgia is a syndrome characterized by chronic widespread pain accompanied by fatigue, disrupted sleep quality, cognitive impairments, subjective soft tissue swelling, and somatic symptoms. There are conflicting results in the literature regarding the prevalence of vitamin D deficiency in fibromyalgia patients and the reduction of symptoms after supplementation. AIMS: Our study aims to evaluate the effectiveness and reliability of vitamin D supplementation in patients diagnosed with fibromyalgia. METHODS: In our cross-sectional clinical study, 180 female patients aged 18 to 65 diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Diagnostic Criteria were included. Oral vitamin D3 replacement of 50,000 IU was administered for 12 weeks. Patients' Fibromyalgia Impact Questionnaire (FIQ)and Visual Analogue Scale (VAS) scores were evaluated before and after the study. RESULTS: Significant differences were observed in the FIQ scores of the 180 fibromyalgia patients before and after vitamin D supplementation (p < 0.05). There was also a significant improvement in VAS scores (p < 0.01). A negative correlation between vitamin D and VAS as well as FIQ scores was found in the study. CONCLUSION: We determined that vitamin D deficiency is significantly more prevalent in patients diagnosed with fibromyalgia. Vitamin D supplementation was observed to have a positive effect on quality of life and reduction of pain.

Racial Disparities in Pain Among Women with Fibromyalgia: Secondary Data Analysis of Severity, Interference with Function, and Response to Guided Imagery.

Background: Fibromyalgia syndrome (FMS) is characterized by widespread persistent musculoskeletal pain. Mostly prevalent among White women, little is known about FMS in other population cohorts. This study examined secondary data of a racially diverse sample of women with FMS that were collected as part of a randomized controlled clinical trial that examined the effect of a complementary therapy intervention over the course of a 10-week guided imagery intervention to identify demographic, social, or economic differences in self-reported pain. Materials and Methods: The Brief Pain Inventory (BPI), which measures pain severity and interference, was administered to 72 women (21 Black and 51 Whites) at baseline, 6 and 10 weeks. Student's t tests and time series regression models examined racial difference in pain dimensions and treatment response. Regression models accounted for age, race, income, duration of symptoms, treatment group, pain at baseline, smoking, alcohol use, comorbid conditions, and time. Results: Black women experienced significantly higher pain severity (ß = 5.52, standard deviation [SD] = 2.13) and interference (ß = 5.54, SD = 2.74) than Whites (severity ß = 4.56, SD = 2.08; interference ß = 4.72, SD = 2.76) (interference: t = 1.92, p = 0.05; severity: t = 2.95, p = 0.00). Disparities persisted over time. Controlling for differences in age, income, and previous pain levels, Black women had 0.26 (standard error [SE] = 0.065) higher pain severity and 0.36 (SE = 0.078) higher interference than Whites. Low-income earners also experienced 2.02 (SE = 0.38) and 2.19 (SE = 0.46) higher pain severity and interference, respectively, than other earners. Results were robust to inclusion of comorbidities. Conclusions: Black women and low-income earners experienced significantly higher levels of pain severity and interference and a lower dose response to the intervention. Differentials were robust to inclusion of demographic, health, and behavioral characteristics. Findings suggest that external factors may contribute to pain perception among women with FMS.

Combination analgesic development for enhanced clinical efficacy (the CADENCE trial): a double-blind, controlled trial of an alpha-lipoic acid-pregabalin combination for fibromyalgia pain.

ABSTRACT: Drug therapy for fibromyalgia is limited by incomplete efficacy and dose-limiting adverse effects (AEs). Combining agents with complementary analgesic mechanisms-and differing AE profiles-could provide added benefits. We assessed an alpha-lipoic acid (ALA)-pregabalin combination with a randomized, double-blind, 3-period crossover design. Participants received maximally tolerated doses of ALA, pregabalin, and ALA-pregabalin combination for 6 weeks. The primary outcome was daily pain (0-10); secondary outcomes included Fibromyalgia Impact Questionnaire, SF-36 survey, Medical Outcomes Study Sleep Scale, Beck Depression Inventory (BDI-II), adverse events, and other measures. The primary outcome of daily pain (0-10) during ALA (4.9), pregabalin (4.6), and combination (4.5) was not significantly different ( P = 0.54). There were no significant differences between combination and each monotherapy for any secondary outcomes, although combination and pregabalin were both superior to ALA for measures of mood and sleep. Alpha-lipoic acid and pregabalin maximal tolerated doses were similar during combination and monotherapy, and AEs were not frequent with combination therapy. These results do not support any additive benefit of combining ALA with pregabalin for fibromyalgia. The observation of similarly reached maximal tolerated drug doses of these 2 agents (which have differing side-effect profiles) during combination and monotherapy-without increased side effects-provides support for future development of potentially more beneficial combinations with complementary mechanisms and nonoverlapping side effects.

Efficacy of mecobalamin (vitamin B12) in the treatment of long-term pain in women diagnosed with fibromyalgia: protocol for a randomised, placebo-controlled trial.

INTRODUCTION: Fibromyalgia causes long-term pain. It affects at least 2% of the population, the majority being women. In addition, extended symptoms corresponding to vitamin B12 deficiency occur. Findings from several studies have indicated that vitamin B12 may be a possible treatment for pain in fibromyalgia. The aim of the proposed study is to evaluate whether vitamin B12 decreases pain sensitivity and the experience of pain (ie, hyperalgesia and allodynia) in women with fibromyalgia. METHODS AND ANALYSIS: The study is a randomised, placebo-controlled, single-blind, clinical trial with two parallel groups which are administered mecobalamin (vitamin B12) or placebo over 12 weeks. 40 Swedish women aged 20-70 years with an earlier recorded diagnosis of fibromyalgia are randomised into the placebo group or the treatment group, each consisting of 20 participants. Outcomes consist of questionnaires measured at baseline and after 12 weeks of treatment. A final re-evaluation will then follow 12 weeks after treatment ends. The primary outcome is tolerance time, maximised to 3 min, which is assessed using the cold pressor test. In order to broaden the understanding of the lived experience of participants, qualitative interviews will be conducted using a phenomenological approach on a lifeworld theoretical basis (reflective lifeworld research approach). ETHICS AND DISSEMINATION: The protocol for the study is approved by the local ethical committee at Linkoping (EPM; 2018/294-31, appendices 2019-00347 and 2020-04482). The principles of the Helsinki Declaration are followed regarding oral and written consent to participate, confidentiality and the possibility to withdraw participation from the study at any time. The results will primarily be communicated through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: NCT05008042.

The dose-dependent effects of transcutaneous electrical nerve stimulation for pain relief in individuals with fibromyalgia: a systematic review and meta-analysis.

ABSTRACT: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological modality widely used to manage pain; however, its effectiveness for individuals with fibromyalgia (FM) has been questioned. In previous studies and systematic reviews, variables related to dose of TENS application have not been considered. The objectives of this meta-analysis were (1) to determine the effect of TENS on pain in individuals with FM and (2) determine the dose-dependent effect of TENS dose parameters on pain relief in individuals with FM. We searched the PubMed, PEDro, Cochrane, and EMBASE databases for relevant manuscripts. Data were extracted from 11 of the 1575 studies. The quality of the studies was assessed using the PEDro scale and RoB-2 assessment. This meta-analysis was performed using a random-effects model that, when not considering the TENS dosage applied, showed that the treatment had no overall effect on pain (d+ = 0.51, P > 0.050, k = 14). However, the moderator analyses, which were performed assuming a mixed-effect model, revealed that 3 of the categorical variables were significantly associated with effect sizes: the number of sessions ( P = 0.005), the frequency ( P = 0.014), and the intensity ( P = 0.047). The electrode placement was not significantly associated with any effect sizes. Thus, there is evidence that TENS can effectively reduce pain in individuals with FM when applied at high or at mixed frequencies, a high intensity, or in long-term interventions involving 10 or more sessions. This review protocol was registered at PROSPERO (CRD42021252113).

A case-control analysis of the associations between Fibromyalgia Syndrome and Osteoporosis.

BACKGROUND: Fibromyalgia syndrome (FMS) is characterized by widespread musculoskeletal pain and tenderness with associated neuropsychological symptoms such as fatigue, unrefreshing sleep, cognitive dysfunction, anxiety, and depression. Osteoporosis is defined as a reduction of bone density. Previous studies to determine an association of FMS with osteoporosis showed mixed results, partially due to small sample sizes and lack of statistical power. OBJECTIVES: To evaluate the association of FMS with osteoporosis. METHODS: We conducted a case-control study utilizing the database from Israel's largest health maintenance organization. FMS patients were compared to age- and sex-matched controls. Data were analyzed using chi-square and t-tests. Multivariable logistic regression models assessed the association between osteoporosis and FMS. Spearman's rho test was used for correlation. RESULTS: We utilized data from 14,296 FMS patients and 71,324 age- and sex-matched controls. Spearman's rho test showed a significant correlation between FMS and osteoporosis (correlation coefficient 0.55, P < 0.001). A logistic regression for osteoporosis showed an odds ratio [OR] of 1.94 (95% confidence interval [95%CI] 1.83-2.06, P < 0.001) for FMS compared to controls and found higher body mass index to be slight protective (OR 0.926, 95%CI 0.92-0.93, P < 0.001). CONCLUSIONS: There is a significant correlation between FMS and osteoporosis. Early detection of predisposing factors for osteoporosis in FMS patients and implementation of suitable treatments and prevention measures (such as dietary supplements, resistance or weight bearing exercise, and bone-mineral enhancing pharmacological therapy) may reduce both occurrence rate and severity of osteoporosis and its complications, such as fractures.

The frequency of fibromyalgia in familial Mediterranean fever and its impact on the quality of life.

BACKGROUND AND AIM: Concomitant fibromyalgia syndrome (FMS) has been known to be more frequent in patients with several rheumatic diseases. In this study, our aim was to investigate the prevalence of FMS in patients with familial Mediterranean fever (FMF), to analyze the possible factors related to this frequency, and to evaluate the impact of FMS on the functionality and quality of life (QoL) of the patients with FMF. PATIENTS AND METHODS: One hundred cases with FMF and 100 controls were included to this case-control study. FMS coincidence was investigated in all participants according to revised 2016 classification criteria. Demographic features, FMF disease duration, FMF gene mutations, drugs used, attack frequency per year, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and serum fibrinogen levels were recorded. FMF disease severity was assessed by International Severity Scoring System for Familial Mediterranean Fever (ISSF). For the assessments of QoL and functioning, FMF-QoL, Short form 36 (SF-36), and Health Assessment Questionnaire-Disability Index (HAQ-DI) were used, and for the assessment of FMS impact, the fibromyalgia impact questionnaire (FIQ) were used. RESULTS: We found an FMS frequency of 33% in patients with FMF in our study using the current FMS classification criteria. This result was significantly higher than in age- and gender-similar controls (6% FMS frequency; P < 0.05). The number of woman patients and FMF disease duration were significantly higher in patients with FMF + FMS than in patients with only FMF (P < 0.001). There was no significant difference in ISSF scores, ESR, CRP, and fibrinogen levels, management regimens, and FMF gene mutation distributions between FMF + FMS and FMF groups. FMF attack frequency was reported as significantly higher in FMF + FMS patients than in others (P < 0.000). In spite of similar FMF-QoL scores, there were significant differences in HAQ-DI and SF-36 scores between groups (P < 0.05). Higher impact of FMS presented negative correlation with functioning and general health, and positive correlation with QoL in FMF + FMS (P < 0.05). CONCLUSION: Concomitant FMS was a common clinical problem in patients with FMF regardless of the severity and characteristics of FMF. The FMS impact may affect function and QoL in patients of FMF. Considerations of the FMS component in the management of FMF may contribute to the holistic approach to FMF.

Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study.

Objective: To examine the efficacy and safety of ozonated autohemotherapy (O3-AHT) combined with pharmacological therapy for comorbid insomnia and myofascial pain syndrome (MPS). Materials and Methods: One hundred and eighteen patients were randomly divided into two groups: the control group (N = 50) and the O3-AHT group (N = 53). Patients in both groups were given the same pharmacological management for three weeks. Patients in the O3-AHT group were treated with ozonated autohemotherapy (the concentration of ozone was 20 µg/ml in the first week, 30 µg/ml in the second week, and 40 µg/ml in the third week) combined with pharmacological therapy. Primary (the insomnia severity index (ISI) and visual analogue scale (VAS)) and secondary outcomes (the Epworth sleepiness scale (ESS), polysomnography data, the anxiety and preoccupation about sleep questionnaire (APSQ), the beck depression index (BDI), and the multidimensional fatigue inventory (MFI)) were examined at pretreatment, posttreatment, 1 month, and 6 months. Results: Fifty patients in the control group and fifty-three patients in the O3-AHT group completed the study. In both groups, insomnia and pain symptoms were relieved significantly compared with pretreatment. Compared with the control group, the O3-AHT group had significantly improved sleep quality, pain, and negative mood at different time points. No adverse complications were observed in either group. Conclusion: Compared with pharmacological therapy alone, ozonated autohemotherapy combined with pharmacological therapy can ameliorate insomnia, reduce pain intensity, improve negative mood, and alleviate fatigue more effectively without serious adverse complications.

Relevance of Religiosity for Coping Strategies and Disability in Patients with Fibromyalgia Syndrome.

Coping strategies are essential for the outcome of chronic pain. This study evaluated religiosity in a cohort of patients with fibromyalgia syndrome (FMS), its effect on pain and other symptoms, on coping and FMS-related disability. A total of 102 FMS patients were recruited who filled in questionnaires, a subgroup of 42 patients participated in a face-to-face interview, and data were evaluated by correlation and regression analyses. Few patients were traditionally religious, but the majority believed in a higher existence and described their spirituality as "transcendence conviction". The coping strategy "praying-hoping" and the ASP dimension "religious orientation" (r = 0.5, P < 0.05) showed a significant relationship independent of the grade of religiosity (P < 0.05). A high grade of belief in a higher existence was negatively associated with the choice of ignoring as coping strategy (r = - 0.4, P < 0.05). Mood and affect-related variables had the highest impact on disability (b = 0.5, P < 0.05). In this cohort, the grade of religiosity played a role in the choice of coping strategies, but had no effects on health and mood outcome.

Veterans' Insights on Heart Rate Variability Biofeedback to Treat Fibromyalgia-Related Pain.

BACKGROUND: Heart rate variability biofeedback (HRVB) is a self-management strategy that guides individuals to breathe at a designated resonance frequency of the cardiovascular system. Resonant breathing may reduce FM-related symptoms as well as improve physical functioning and quality of life. Although prior research recommends HRVB for chronic pain, we found no studies testing the feasibility for individuals with FM regarding protocol adherence or acceptability of the treatment. AIMS: To determine the feasibility and acceptability of a heart rate variability biofeedback (HRVB) protocol in a group of Veterans with fibromyalgia (FM). DESIGN: A multi-method feasibility and acceptability study. SETTINGS: A Veterans Health outpatient pain medicine clinic. PARTICIPANTS/SUBJECTS: We enrolled 7 women and 3 men between the ages of 33 and 68 years with a diagnosis of FM. METHODS: We enrolled 10 veterans in a HRVB study using a recommended protocol to treat FM. Veterans were given a HRVB device, emWave2, and instructed to practice at home twice daily for 20 minutes per session. Following a 7-week intervention period, we conducted an end of study focus group. We used content analysis to develop themes to determine the feasibility of engaging in HRVB and adhering to the intervention protocol, as well as insights of veterans about the intervention. RESULTS: Three common themes emerged: intervention implementation, protocol adherence, and self-awareness. CONCLUSIONS: Results of this study suggest difficulties operating the emWave2 and scheduling challenges interfered with HRVB implementation. However, veterans reported self-awareness of the benefits of HRVB, positive physiological effects, and improved psychological effects. Future studies require a larger sample size to provide a deeper insight.

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.

The risk of fibromyalgia in patients with iron deficiency anemia: a nationwide population-based cohort study.

Since iron is essential for neurotransmitter synthesis, decreased iron stores might lead to reduced production of biogenic amines which phenomenon was shown in Fibromyalgia (FM) patients. The aims are to investigate the association of iron deficiency anemia (IDA) and FM and to find the effects of different interventions. We conducted a study using the Taiwan National Health Insurance Research Database. The IDA cohort consisted of 13,381 patients with newly diagnosed IDA between 2000 and 2008. Each patient with IDA was frequency-matched with one people without IDA, by sex, age and index year. The Cox proportional hazards regression analysis was conducted to estimate the association between IDA and FM risk. The event was the occurrence of FM. The overall incidence density rate of FM in the IDA cohort was higher than in the non-IDA cohort with a multivariable Cox proportional hazards model measured adjusted hazard ratio [HR], 1.19; 95% confidence interval [CI], 1.13-1.25). When using non-IDA group as reference, we compared with different therapies for IDA. The adjusted HRs of FM were 1.38 (95% CI = 1.30-1.47), 1.10 (95% CI = 1.03-1.16), 1.18 (95% CI = 0.98-1.43) and 0.73 (95% CI = 0.58-0.90) for IDA patient without therapy, iron supplement alone, blood transfusion alone and both iron supplement and blood transfusion respectively. Our results suggest IDA is associated with an increased risk of FM. All patients should have iron supplementation both to correct anemia and replenish body stores.

Reduction in movement-evoked pain and fatigue during initial 30-minute transcutaneous electrical nerve stimulation treatment predicts transcutaneous electrical nerve stimulation responders in women with fibromyalgia.

ABSTRACT: We previously showed that 1 month of transcutaneous electrical nerve stimulation (TENS) reduces movement-evoked pain and fatigue in women with fibromyalgia (FM). Using data from this study (Fibromyalgia Activity Study with TENS [FAST]), we performed a responder analysis to identify predictors of clinical improvement in pain and fatigue with TENS, validated these models using receiver operator characteristic, and determined number needed to treat and number needed to harm. Participants were randomly assigned to active-TENS (2-125 Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1 month. At the end of the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1 month. The predictor model was developed using data from the randomized phase for the active-TENS group (n = 103) and validated using data from placebo-TENS and no-TENS groups after active-TENS for 1 month (n = 155). Participant characteristics, initial response to TENS for pain and fatigue, sleep, psychological factors, and function were screened for association with changes in pain or fatigue using a logistic regression model. Predictors of clinical improvement in pain were initial response to pain and widespread pain index (area under the curve was 0.80; 95% confidence interval: 0.73-0.87). Predictors of clinical improvement in fatigue were marital status, sleep impairment, and initial response to TENS (area under the curve was 0.67; 95% confidence interval: 0.58-0.75). Number needed to treat for pain and fatigue ranged between 3.3 and 5.3. Number needed to harm ranged from 20 to 100 for minor TENS-related adverse events. The response to an initial 30-minute TENS treatment predicts who responds to longer-term TENS use in women with FM, making this a clinically useful procedure. Number needed to treat and number needed to harm suggest that TENS is effective and safe for managing pain and fatigue in FM.

Effects of neuro-adaptive electrostimulation therapy on pain and disability in fibromyalgia: A prospective, randomized, double-blind study.

BACKGROUND: To evaluate the effectiveness of non-invasive neuro-adaptive electrostimulation (NAE) therapy for treating chronic pain and disability in patients with fibromyalgia. METHOD/DESIGN: A prospective, randomized, sham-controlled study was conducted in 37 women with fibromyalgia. Participants were randomly assigned to receive either active NAE (n = 20) or stimulation with a sham device (n = 17). Participants in the experimental arm received eight 30-minute sessions over 4 weeks (2 sessions per week). The sham group received eight 30-minute sessions of sham stimulation. Therapeutic effects on pain relief, disability, and quality of life were evaluated using outcome measures at baseline, at 4 weeks, and after 3 months' follow-up. RESULTS: The findings indicated a significant reduction of pain in the active NAE group compared with the sham group immediately post-intervention, with a difference on the Visual Analog Scale (VAS) of 3 points (P = .001), and at 3 months' follow-up (P = .02). There were significant intragroup differences between the groups (P < .05) at post-intervention. After the intervention, both groups presented significant reductions on the Fibromyalgia Impact Questionnaire (FIQ) with respect to baseline (P = .004), but not at the 3-month follow-up. In the conditioned pain modulation (CPM) in thumb variable we found significant differences between the groups at the 3-month follow-up (P = .02). No additional benefits for conditioned pain modulation and disability were observed between groups at the 3-month follow-up. Furthermore, anxiety/depression and catastrophizing improved in both groups, but no differences between groups were found. CONCLUSIONS: In this fibromyalgia cohort, NAE therapy significantly improved pain and quality of life at 4 weeks, but not at 3-month follow-up, compared with the sham stimulation group. Future investigations are needed in larger populations to confirm these findings.

Acupuncture decreased the risk of stroke among patients with fibromyalgia in Taiwan: A nationwide matched cohort study.

BACKGROUND: The aim of this study was to investigate the effectiveness of acupuncture in decreasing the risk of stroke in patients with fibromyalgia. METHODS: We enrolled patients who was newly diagnosed as having fibromyalgia between 1 January, 2000 and 31 December, 2010 from the Taiwanese National Health Insurance Research Database. The claim data for both the acupuncture cohort and non-acupuncture cohort were assessed from the index date to 31 December, 2013. A Cox regression model adjusted for age, sex, comorbidities, and drugs use was used to compare the hazard ratios of the two cohorts. The cumulative incidence of stroke was estimated by using the Kaplan-Meier method. RESULTS: After performing a propensity score matching with a 1:1 ratio, there were 65,487 patients in the acupuncture and non-acupuncture cohorts with similar distributions in the baseline characteristics. The cumulative incidence of stroke was significantly lower in the acupuncture cohort (log-rank test, p < 0.001). In the follow-up period, 4,216 patients in the acupuncture cohort (11.01 per 1000 person-years) and 6,849 patients in the non-acupuncture cohort (19.82 per 1000 person-years) suffered from stroke (adjusted HR 0.53, 95% CI 0.51-0.55). Acupuncture favorably affected the incidence of stroke regardless of the patient's age, sex, comorbidities, and conventional drug use. CONCLUSIONS: Our study found that acupuncture might have a beneficial effect on reducing the risk of stroke in patients with fibromyalgia in Taiwan. Additional clinical and basic science studies are warranted.

Efficacy of Manual Therapy on Pain, Impact of Disease, and Quality of Life in the Treatment of Fibromyalgia: A Systematic Review.

BACKGROUND: Myofascial mobilization has been used as an intervention for patients with fibromyalgia (FM) for acting on ascending nociceptive pathways possibly involved in the central sensitization process, modulating the pain experience. However, there is still a gap in its efficacy compared with another hands-on approach because manual therapy has nonspecific effects, such as placebo. OBJECTIVES: This systematic review aims to review the scientific literature for an overview of the efficacy of manual therapy in pain, disease impact, and quality of life in patients with FM compared with control or other treatments through randomized clinical trials. STUDY DESIGN: This study involved systematic review of published randomized controlled trials (RCTs). SETTING: This study examined all RCTs evaluating the effect of manual therapy on pain, impact of disease, and quality of life for patients with FM. METHODS: Systematic review. The research was performed in 9 databases: MEDLINE/PubMed, CINAHL, Web of Science, Scopus, ScienceDirect, Lilacs, SciELO, PEDro, and Cochrane. Searches were carried out from the end of the project until September 2019, with no language and year restrictions. Randomized controlled clinical trials that used the following outcome measures were included: Visual Analog Scale, Fibromyalgia Impact Questionnaire, and SF-36 Quality of Life Questionnaire. The risk of bias and quality of studies was assessed using the PEDro scale; the Cochrane risk-of-bias tool; and Grading of Recommendations Assessment, Development, and Evaluation System. RESULTS: Seven studies were included (368 patients). The quantitative analysis was performed on 4 studies because of the lack of data in the others. Myofascial release was the most used modality. The level of evidence ranged from very low to moderate, mainly because of the inconsistency and inaccuracy of results. LIMITATIONS: The present systematic review presented limitations because of the heterogeneity of the included studies and only a short-term analysis of the intervention results. It was observed that other information, such as pressure, repetition, and/or sustaining manual therapy techniques, could be better described in future protocols, aiming at a better comparison between the techniques and their subsequent reproducibility. CONCLUSIONS: Current evidence of manual therapy in patients with FM, based on a very low to moderate quality of evidence, was inconclusive and insufficient to support and recommend the use of manual therapy in this population. To date, only general osteopathic treatment has achieved clinically relevant pain improvement when compared with control.

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.

Hypnotic intervention in people with fibromyalgia: A randomized controlled trial.

Fibromyalgia affects the quality of life of the patients, as well as their family. It also affects their social, labor, physical, and psychological dynamics. We aimed to evaluate the effectiveness of audio-recorded hypnosis in ameliorating fibromyalgia symptoms. We enrolled 97 individuals with fibromyalgia (mean age: 45 years) and randomly distributed them to two groups (48 in the experimental group and 47 in the control group). Individuals in both groups maintained their standard pharmacological treatment and continued their usual physical or psychological activities. The experimental group received an audio-recorded hypnosis intervention in the first session; subsequently, they received another audio hypnosis session to use for daily practice for a month. We evaluated the pre- and post-intervention pain intensity, pain interference, fatigue intensity, fatigue interference, depressive symptomatology, and satisfaction with life. We found that the self-administered audio-recorded hypnotic intervention significantly decreased the intensity and interference of pain and fatigue, as well as the depressive symptomatology. Audio-recorded clinical hypnosis techniques could provide an effective, practical, and economical alternative for reducing fibromyalgia-related symptoms.

The early diagnosis of fibromyalgia in irritable bowel syndrome patients.

Irritable bowel syndrome (IBS) is a common disorder worldwide, but the diagnosis is often overlooked. This study aimed to evaluate the sociodemographic characteristics of IBS patients and the relationship between IBS and fibromyalgia. 202 patients with gastrointestinal system complaints who were admitted to Sisli Hamidiye Etfal Trainnig and Research Hospital, Family Medicine Clinic were included in the study. P < 0.05 was considered statistically significant. Fibromyalgia was associated with IBS in 26.7% of the participants. There was a positive correlation between the incidence of fibromyalgia and use of medication due to IBS, change in stool frequency, generalized pain, frequent illness, headache, excessive stress cancer anxiety , workforce loss due to IBS symptoms and fibromyalgia (p < 0.05). The presence of generalized pain, among IBS symptoms, caused the most robust increase in the likelihood of fibromyalgia (80%). The symptoms which were increasing the possibility of fibromyalgia were mostly generalized pain, high WHOQOL total score, family history of cancer, and loss of workforce at admission. IBS is a condition that affects the daily life quality of individuals and is often a condition that can be confused or associated with other diseases. Primary care physicians should approach patients holistically, especially in patients with generalized pain, family history of cancer, loss of workforce at admission, and more careful about fibromyalgia in patients with high WHOQOL total score. This awareness will increase the chances of early diagnosis and treatment of patients and will provide less cost but more effective treatment.