Revised Fibromyalgia Impact Questionnaire Research Articles

Role of Repetitive Transcranial Magnetic Stimulation in Treatment of Fibromyalgia: A Randomized Controlled Trial.

Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread, persistent musculoskeletal pain in association with impaired health-related quality of life. Repetitive transcranial magnetic stimulation (rTMS) is an emerging tool for the management of fibromyalgia. There is no standardized protocol of rTMS for the treatment of FMS, and both low- and high-frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) are described in the literature with variable efficacy. The objective of this study was to determine the effectiveness of rTMS in people with fibromyalgia and compare the response of low- and high-frequency stimulation with sham stimulation. This study was a single-blinded, randomized, placebo-controlled trial. Ninety patients with the diagnosis of FMS were randomly allocated into one of the following three groups: low-frequency (1 Hz) group, high-frequency (10 Hz) group, and sham group. Pain, depression, anxiety, and quality of life were measured using the Numerical Pain Rating Scale (NPRS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HDRS), and Revised Fibromyalgia Impact Questionnaire (FIQR) immediately following treatment as well as at 1 and 3 months after treatment. The data was statistically analyzed using Statistical Package for the Social Sciences version 23 software. P value < 0.05 was considered statistically significant. Intergroup analysis revealed a significant improvement in NPRS, HAM-A, HDRS, and FIQR scores in both low- and high- frequency groups immediately following treatment and for 3 months after treatment. No significant difference in the efficacy of low- and high-frequency stimulation was noticed. rTMS is an effective mode of treatment in people with FMS. Both low and high frequencies of stimulation at DLPFC are equally effective in reducing pain and associated symptoms.

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

ObjectiveTo determine the efficacy of two physiotherapeutic interventions – aquatic therapy (AT) and land-based therapy (LBT) – for reducing pain in women with fibromyalgia. DesignSingle-blind, randomised controlled, equivalence trial. SettingFibromyalgia, Chronic Fatigue Syndrome and Multiple Chemical Sensitivity Association in A Coruña, Spain. ParticipantsForty women with fibromyalgia were assigned at random in a 1:1 manner to two groups: AT (n = 20) and LBT (n = 20). InterventionsTwo 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. OutcomeThe 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. ResultsThe 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. ConclusionsThe 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 NumberClinicalTrials.gov NCT02695875 Contribution of the paper•This paper provides evidence that aquatic therapy is an effective intervention for reducing pain and improving sleep quality of women with fibromyalgia.•The matched protocols designed for this study highlighted the influence of the environment on symptom management in women with fibromyalgia.

Cross‐sectional and longitudinal analysis of conditioned pain modulation and pain in fibromyalgia: CPM as an effect modifier of pain changes over time

AbstractBackground and PurposeFibromyalgia (FM) is associated with altered descending pain modulatory pathways, which can be assessed through Conditioned Pain Modulation (CPM). In this study, we aimed to explore the relationship between CPM and self‐reported baseline characteristics in patients with fibromyalgia. We also performed a longitudinal analysis exploring CPM as a potential predictor of clinical improvement over time in individuals with FM.MethodsWe performed cross‐sectional univariable and multivariable analyses of the relationship between CPM and other variables in 41 FM patients. We then performed longitudinal analyses, building linear mixed‐effects models with pain in the Visual Analogue Scale (VAS) as the dependent variable, and testing for the interaction between time and CPM. We also tested the interaction between CPM and time in models using other outcomes, such as the revised Fibromyalgia Impact Questionnaire and Quality of Life Scale (QOLs).ResultsWe found no association between CPM and other demographic and clinical variables in the univariable analysis. We found a statistically significant association in the multivariable linear regression model between CPM and the QOLs at the baseline after controlling for age, sex, and duration of symptoms. In the longitudinal analyses, we found that CPM is an effect modifier for clinical improvement over time for the pain VAS, QOLs, and FIQR: individuals with low‐efficient CPM at the baseline have a different (improved) pattern of response over time when compared to those with high‐efficient CPM.ConclusionsOur findings suggest that CPM is not a reliable biomarker of clinical manifestations in chronic pain patients during cross‐sectional assessments. However, our results are consistent with previous findings that CPM can be used to predict the evolution of clinical pain over time. We expect that our findings will help in the selection of patients with the best profile to respond to specific interventions and assist clinicians in tailoring pain treatments.

Frequency of idiopathic intracranial hypertension with ultrasound in patients with fibromyalgia: Relation with function, central sensitization, and neuropathic pain.

The purpose of this study was to evaluate the prevalence of idiopathic intracranial hypertension (IIH) in fibromyalgia (FMS) patients by utilizing ultrasound to measure the optic nerve sheath diameter (ONSD), a marker of elevated intracranial pressure and also to investigate the relationship with function, fatigue, quality of life (QOL), central sensitization (CS) and neuropathic pain. The study encompassed 80 female FMS patients and 75 healthy controls. Ultrasound was employed to measure the average ONSD in both groups. Conditions potentially elevating intracranial pressure were ruled out following neurological assessments. Pain (via visual analog scale, VAS), function (revised Fibromyalgia Impact Questionnaire, r-FIQ), QOL (Short Form-36, SF-36), fatigue (fatigue severity scale, FACIT), CS (Central Sensitization Scale), and neuropathic pain (Douleur Neuropathique-4) were evaluated. The average ONSD was significantly higher in the patient group than the control group. Patients with ONSD >5.5 mm consistent with IIH were categorized as Group 1 (n = 54, 67.5%), while those with a diameter of 5.5 mm and below-formed Group 2. VAS pain (p = .033) and FIQ-R scores (p = .033) were significantly higher in Group 1 than Group 2. Headache was found more common in Group 1. This study unveils a substantial occurrence (67.5%) of IIH in FMS patients, suggesting shared pathophysiological mechanisms contributing to symptoms like fatigue, headache, and cognitive dysfunction. Additionally, these findings implicate heightened functional impairment, CS, headache, and fatigue in FMS patients with IIH.

Factors that influence medication adherence in women with fibromyalgia: A path analysis.

To investigate the relationships between depression symptoms, perceived stigma, disease severity, patient-provider communication and medication adherence in fibromyalgia patients. The objectives were to explore how these factors influence treatment adherence and to develop a comprehensive model illustrating their interconnections. Fibromyalgia is a chronic pain syndrome with fatigue, sleep issues and idiopathic pain. Medication adherence is limited by insufficient symptom relief, side effects and costs. Stigma further complicates fibromyalgia. Disease severity affects patient-provider communication. Associations between depression, stigma, severity, communication and adherence in fibromyalgia are unclear. A cross-sectional, correlational study. The STROBE guidelines for cross-sectional studies were followed. Participants included Hebrew-speaking participants who were members of two Facebook groups: 'Shades of Purple' and 'Fibromyalgia- Get to Know!' Between February and April 2022. They undertook evaluations using The Patient Health Questionnaire-9 to gauge depression symptoms, assessed perceived stigma, utilised The Revised Fibromyalgia Impact Questionnaire to determine disease severity, employed The Patient Reaction Assessment questionnaire for patient-provider communication, and used the 8-item Morisky Medication Adherence Scale (MMAS-8). Associations between the variables were explored using Pearson's correlations and path analyses. The study included 141 women with fibromyalgia, aged 22 to 76 years. Most reported having a stable partner (69.5%) and 75.2% had children. The treatment adherence levels were as follows: 53.2% (N = 75)-low, 33.3% (N = 47)-medium and 13.5% (N = 19)-high. Depression positively correlated with stigma. Stigma negatively correlated with patient-provider communication. Patient-provider communication positively correlated with treatment adherence. A significant negative indirect effect of depression on treatment adherence through stigma and patient-provider communication was found. Perceived stigma and patient-provider communication played a mediating role in the relationships between depression and treatment adherence among women with fibromyalgia. Addressing stigma related to fibromyalgia and effective patient-provider communication can positively influence treatment adherence. No patient or public contribution.

A retrospective analysis of the prevalence and impact of associated comorbidities on fibromyalgia outcomes in a tertiary care center.

This retrospective study was designed to analyze the prevalence and impact of associated comorbidities on fibromyalgia (FM) outcomes (functionality, pain, depression levels) for patients who participated in an intensive multicomponent clinical program in a tertiary care center. Participants included a sample of 411 patients diagnosed with FM at a large tertiary medical center using the 2016 ACR criteria. Patients completed an intensive 2-day cognitive behavioral treatment (CBT) program, filled out the Fibromyalgia Impact Questionnaire Revised (FIQR), the Center for Epidemiologic Studies Depression Scale (CES-D), the Pain Catastrophizing Scale (PCS), and were followed for 6 months after treatment completion. T-tests were performed to analyze differences between the presence or absence of select comorbidities for the three outcomes at follow-up. Statistically significant comorbidities (p < 0.05) were used as predictors in multivariable logistic regression models. The FM associated comorbidities in this cohort that had significant impact on the measured outcome domains after treatment program completed were Obesity (FIQR p = 0.024), Hypothyroidism (CES-D p = 0.023, PCS p = 0.035), Gastroesophageal reflux disease GERD (PCS p < 0.001), Osteoarthritis (CES-D p = 0.047). Interestingly, Headache, the most frequent FM associated comorbidity in this cohort (33.6%), did not have a significant impact on the outcome domains at follow-up. Obesity (18.2%) was the only FM associated comorbidity significantly impacting all three outcome domains at follow-up. The present study suggests that addressing obesity may significantly impact outcomes in FM patients.

Significance of inflammatory markers in primary Fibromyalgia syndrome and their relation in assessing the disease severity

Fibromyalgia syndrome (FMS) is a musculoskeletal disorder characterized by diffuse chronic musculoskeletal pain associated with various other symptoms. Although the etiology and pathogenesis of FMS are still unclear, it was reported to have a possible inflammatory basis. No laboratory marker is currently available to diagnose the disease. This study aimed to search for biomarkers useful in diagnosis of FMS. We assessed blood erythrocyte sedimentation rate (ESR), neutrophil lymphocyte ratio (NLR), the mean platelet volume (MPV) and platelet distribution width (PDW), and serum levels of C-reactive protein (CRP), as inflammatory markers in primary FMS patients and their relationship with disease severity and depression scores. The study included 30 FMS patients, diagnosed according to the 2010 ACR (American Colleague of Rheumatology) criteria and 30 normal volunteers as a control group. FMS patients filled out the Revised Fibromyalgia Impact Questionnaire (FIQR) and Montgomery Asberg Depression Score (MADRS) as well. There was a significant difference in the studied parameters including ESR, CRP, NLR, MPV between study patients and control groups (p&lt;0.05 for all). However, PDW did not differ between the two study groups. Based on our study findings, we can conclude that serum levels of the tested inflammatory markers including ESR, CRP, NLR, and MPV were higher in patients than in controls which makes them of good diagnostic value in patients with fibromyalgia. Meanwhile, some of these markers, mainly the acute phase reactants, have a positive relation with disease severity and depression scores, which in turn affect the quality of daily living.

Translation, Cross-Cultural Adaptation, and Psychometric Properties of the Revised Fibromyalgia Impact Questionnaire (FIQR) for Use in Arabic-Speaking Patients in Saudi Arabia.

Fibromyalgia (FM) is a complex and debilitating condition that significantly impacts patients' daily lives. The continuous assessment of the impact and severity of FM is essential to manage the condition effectively. Assessment tools in Arabic are lacking for use in Saudi Arabia, which might lead to ineffective management. This study aimed to translate and cross-culturally adapt and validate the Arabic version of the Revised Fibromyalgia Impact Questionnaire (FIQR). Following translation guidelines, 2 Arabic translators and 2 English-certified translators performed forward and backward translations of the FIQR. In a cross-sectional study design, the questionnaire was piloted with 5 participants and then subjected to cognitive interviews and psychometric analysis. Participants were FM patients recruited from a University Hospital in Riyadh and FM support groups in Saudi Arabia. The internal consistency, and reliability using the Cronbach α and interclass correlation coefficient (ICC) of 2-week test-retest, and criterion validity were evaluated. The results included a total of 42 participants with FM. Six minor modifications were made during the stepwise translation of the questionnaire. The Arabic version of the FIQR had good internal consistency and test-retest reliability, with a Cronbach α of 0.855 for the physical functioning domain, 0.663 for overall well-being, 0.803 for symptoms, and 0.895 for the total FIQR, and the Pearson correlation coefficient of the ICC for physical functioning was 0.769 (95% confidence interval (CI), 0.541-0.884) for the overall well-being domain, 0.555 (95% CI, 0.129-0.772) for the symptoms domain, and 0.720 (95% CI, 0.370-0.868) and 0.794 (95% CI, 0.579-0.899) for the total FIQR score (p < 0.001), respectively. The Arabic version of the FIQR is a valid, reliable, and practical tool for assessing the impact of FM on Arabic-speaking patients and potentially contributing to the improvement of FM outcomes.

Do FIQR Severity Categories and Symptoms, Differentiate Between Continuous, Intermittent and Non-Opioid Users in the Treatment of Fibromyalgia?

BackgroundMany fibromyalgia patients utilize opioids to treat symptoms. It is important to better understand nuances regarding this treatment option and any stigma associated with this treatment modality. AimThis study: (1) assessed the prevalence of opioid use among continuous, intermittent, and non-opioid users in fibromyalgia patients; (2) determined whether the Revised Fibromyalgia Impact Questionnaire (FIQR) was useful in distinguishing opioid use and symptom burden; and (3) assessed whether fibromyalgia patients encountered stigma and/or invalidation. DesignA cross-sectional, observational study of 1,105 participants’ responses to validated fibromyalgia and invalidation scales and demographic questions. MethodsThe study employed online survey methodology. ResultsA total of 45% of patients reported utilizing opioids (27% continuous, 18% intermittent, 55% non-users). FIQR disease categories (mild to most severe) strongly distinguished between opioid and non-opioid users with 59% of users falling in the most severe category and 68% of non-users falling in mild disease category (p < .0001). Interestingly, intermittent users were similar to non-users on FIQR severity (65.9 versus 65.7; p <0.60, 0-100) while continuous users reported greater severity than the former (73.9, p < .0001). Continuous users particularly reported more problems with daily activities (p < .0001), being overwhelmed (p < .0001), and being unable to accomplish goals (p < .0001). Stigma related to being ‘drug seeking’ and being ‘judged’. Invalidation was infrequent. ConclusionsOpioid use is common in fibromyalgia and increases monotonically with FIQR severity. Multidisciplinary approaches which help patients perform daily activities, decrease feelings of overwhelm, accomplish goals, and reduce stigma may be beneficial.

Loss of cervical lordosis in chronic neck pain patients with fibromyalgia: A cross-sectional study.

Some interrelationships among fibromyalgia (FM), loss of cervical lordosis (LCL), and headache have been reported. Thus, it is sensible to examine LCL as a factor underlying FM and headache. In this study we aimed to assess LCL in chronic neck pain patients (CNPP) with FM and its association with headache features and FM severity. CNPP with (n= 55; mean age 40.0 ± 8.5; range 20 to 55 years) and without FM (n= 55; mean age 38.5 ± 8.9; range 20 to 55 years) were included in the study. Cervical lordosis was assessed by measuring the Cobb angle on the lateral cervical radiographs. The patients were asked about headache features within the last month. In addition, the CNPP with FM were evaluated by the Turkish version of the Revised Fibromyalgia Impact Questionnaire. There were no statistically significant differences between the groups in terms of age, weight, height, body mass index, working status, and neck pain duration (p> 0.05 for each). The CNPP with FM had significantly reduced cervical lordosis angle compared with those without. The CNPP with FM had significantly higher headache frequency than those without (p= 0.008). There was statistically significant negative correlation between cervical lordosis angle and headache frequency in the CNPP with FM (r: -0.336; p= 0.012). According to the results of this study, LCL may be associated with FM and headache frequency in the CNPP with FM.

Significant use of non-evidence-based therapeutics in a cohort of Australian fibromyalgia patients.

Fibromyalgia is a common condition characterised by chronic widespread musculoskeletal pain and central sensitivity features. Appropriate management requires a multidisciplinary approach prioritising non-pharmacological strategies. Evidence-based fibromyalgia medications are not always easily available, effective or tolerated. To characterise actual medication usage in Australian fibromyalgia patients. Demographic and clinical data, including medication use information, were gathered by chart review from patients attending the Monash Fibromyalgia Clinic between January 2019 and June 2022. Eligible patients were invited to complete an anonymous questionnaire between June and August 2022 to assess current therapeutic use. The questionnaire assessed fibromyalgia clinical features by using the Revised Fibromyalgia Impact Questionnaire and the 2016 modified American College of Rheumatology Fibromyalgia criteria. The chart review included 474 patients, and 108 participants completed the questionnaire. Most chart review (78.7%) and questionnaire participants (85.2%) reported using at least one medication for their fibromyalgia. 48.5% of chart review patients and 58.3% of questionnaire participants reported using at least one evidence-based medication, usually amitriptyline, duloxetine or pregabalin. However, the most common individual medications for questionnaire participants were non-steroidal anti-inflammatory drugs (48.2%), paracetamol (59.3%) and opioids (34.3%), with most opioids being typical opioids. Among questionnaire participants, 14.8% reported using cannabinoids, and 70.4% reported using at least one supplement, vitamin or herbal/naturopathic preparation. Not all medication or substance use was recorded during clinic appointments. Fibromyalgia patients engage in various pharmacotherapeutic strategies that are not always evidence-based or disclosed to their treating clinicians.

Psychometric testing of the Rheumatoid Arthritis Work Instability Scale in employed people with fibromyalgia.

The aim of the study was to establish whether the Rheumatoid Arthritis Work Instability Scale (RA-WIS), in its current form, is applicable for use with employed people with fibromyalgia (FM) to identify the risk of work disability and need for work rehabilitation. Content validity was first investigated using cognitive debriefing interviews. Participants completed a postal questionnaire. Construct validity was assessed using Rasch analysis. Concurrent validity included testing between the RA-WIS and work (e.g., Workplace Activity Limitations Scale) and health (FM Impact Questionnaire-Revised (FIQ-R) scales. Two weeks later, participants were mailed a second questionnaire to measure test-retest reliability. Interviews were conducted with 13 participants with FM. All RA-WIS items were considered very or extremely relevant by almost all participants, with only one suggesting other items (anxiety and brain fog). Questionnaire responses were analysed from 156 employed participants: 94% women; 45.71 (SD 10.05) years of age; with time since FM diagnosis 2.99 (4.17) years (symptom duration 8.36 (SD 7.16) years). The RA-WIS mostly satisfied Rasch model requirements and a Rasch transformation scale was created. Concurrent validity was generally good (rs = 0.55-0.66) with work scales and the FIQ-R. Internal consistency (Person Separation Index values) was consistent with group use in FM, not individual level use. Test-retest reliability was excellent, with intraclass coefficient (2, 1)=0.90. The RA-WIS is valid and reliable for group use in employed people with FM. However, further work is needed to develop a WIS for individual use in FM.

Effect of first week-intermittent fasting during Ramadan on the severity of neuropsychiatric symptoms in patients with fibromyalgia: A prospective study

BackgroundFasting has been well-reported as an adjunctive therapeutic approach in some chronic pain syndromes.Aim of the workTo study the effect of Ramadan intermittent fasting (RIF) on the severity of neuropsychiatric symptoms in patients with fibromyalgia.Patients and methodsThis prospective observational study was conducted on 130 females with primary fibromyalgia eligible to fast the first week of Ramadan. The included patients were requested to answer the Revised Fibromyalgia Impact Questionnaire twice; the first targets the last week of Shaaban, while the second targets the first week of Ramadan.ResultsThe mean age of the patients was 42.3 ± 11.03 years. The percentage of patients who improved in pain scores was 47.7%, depression (58.5%) and anxiety (55.4%) after the first week of RIF. The median value for the percent of improvement in pain, depression, and anxiety scores were 20%, 25%, and 25%, respectively. On the other hand, most patients showed worsening in the scores of energy level (56.9%) and sleep quality (60%) after the first week of RIF. The median value for the percent of worsening in the energy level and sleep quality scores were 33.3% and 36.7%, respectively. The percentage of patients who showed no change in stiffness scores was 40%, memory problems (67.7%), tenderness to touch (60.8%), balance problems (88.5%), or sensitivity to loud noises, bright lights, odors, and cold (66.9%) after the first week of RIF.ConclusionRIF may improve pain, anxiety, and depression, while it has deleterious effects on sleep and fatigue among patients with fibromyalgia.

Sleep profile and its correlation with clinical variables in fibromyalgia syndrome: A cross-sectional study

ObjectiveA scarcity of literature exists on sleep quality in fibromyalgia syndrome (FMS) in Indian patients. The current study described the sleep profile of patients with FMS with poor sleep quality residing in urban Bangalore and determined the relationship between poor sleep and fibromyalgia variables. MethodsEighty-six patients with FMS were included in the study. Pittsburgh Sleep Quality Index (PSQI) and Revised Fibromyalgia Impact Questionnaire (FIQR) were used to evaluate the sleep profile and fibromyalgia variables. Spearman's rank correlation, t-test, and one-way analysis of variance were used for the analyses. ResultsNinety-one percent of patients with FMS were identified as poor sleepers (PSQI >5). The mean PSQI global score of the included patients was 12.04 ± 3.5. The global sleep score varied with sex (p = 0.003) and fibromyalgia severity (p = 0.001). A significant correlation was found between PSQI global score and FIQR total score (r = 0.4, p < 0.001), FIQR subdomains (r = 0.2–0.4, p < 0.05), and FMS duration (r = 0.26, p < 0.05). The PSQI global score was also correlated with pain, depression, memory, anxiety, balance, and sensitivity (r = 0.2–0.3, p < 0.05). ConclusionSleep disturbance is highly prevalent in patients with FMS residing in urban Bangalore. Sleep quality tends to worsen in females with increasing FMS severity and duration but does not differ across other demographic variables. Sleep quality is significantly correlated with somatic as well as psychological variables. Future studies evaluating the predictors of poor sleep are needed to further corroborate these findings.

Whole-Body Photobiomodulation Therapy for Fibromyalgia: A Feasibility Trial.

Effective treatment for fibromyalgia (FM) is lacking and further treatment options are needed. Photobiomodulation therapy (PBMT) represents one potential treatment option. Whilst favourable findings have been reported using localised PBMT, no investigations have established the value of whole-body PBMT for the complete set of symptom domains in FM. A single-arm feasibility study was conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. A non-probability sampling method was used to access individuals with FM. The primary outcome measure was identified as the Revised Fibromyalgia Impact Questionnaire (FIQR). Forty-nine participants were screened and twenty-one trial participants entered the trial. Nineteen participants completed the intervention (18 whole-body PBMT sessions over approximately six weeks). Descriptive statistics and qualitative analysis was undertaken to represent feasibility outcomes. Acceptability of the trial device and processes were established. Outcome measures towards efficacy data were guided by core and peripheral OMERACT (outcomes measures in rheumatological clinical trials) domains, utilising a combination of participant-reported and performance-based outcome measures. Data for the embedded qualitative component of the trial were captured by participant-reported experience measures and audio-recorded semi-structured interviews. Positive changes were observed for FM-specific quality of life, pain, tenderness, stiffness, fatigue, sleep disturbance, anxiety, depression and cognitive impairment. Patient global assessment revealed improvements at 6 weeks, with continued effect at 24 weeks. FM-specific quality of life at 24 weeks remained improved compared with baseline scores. The findings provided evidence to support a full-scale trial and showed promise regarding potential efficacy of this novel non-invasive treatment in an FM population.

Validation of the 2011 and 2016 American college of rheumatology diagnostic criteria for fibromyalgia in a Chinese population

Purpose To provide a foundation for clinical diagnosis, epidemiological investigation and intervention trials, we examined the reliability and validity of the American College of Rheumatology (ACR) 2011 and 2016 survey diagnostic criteria among Chinese patients based on the fibromyalgia severity (FS) scale. Methods In this study, 200 fibromyalgia patients diagnosed according to the 1990 criteria (1990c) were matched with rheumatoid arthritis (RA) patients based on age and gender. The FS scale score and its subscales were examined to determine their correlations with the revised fibromyalgia impact questionnaire (FIQR). Receiver operator characteristic (ROC) analysis was performed, and test-retest reliability, internal consistency, and construct validity were examined. Results The area under the curve (AUC) for the ACR 2011c and 2016c was 0.870 and 0.845, respectively, and the sensitivity and specificity were 78.0% and 96.0% for the 2011c and 70.5% and 98.5% for the 2016c, respectively. The FS scale and its subscales were confirmed to exhibit good internal consistency, and they were significantly correlated with the FIQR, thereby indicating adequate construct validity. Using a lower cutoff value 11 points for the FS scale score based on the generalized pain requirement might be a more effective approach in the Chinese population; this approach yielded an AUC of 0.923 and a sensitivity of 87.0% and specificity of 97.5%. Conclusion The 2011c and 2016c are reliable instruments for diagnosing fibromyalgia patients in China. The FS scale could be a valid tool to assist in fibromyalgia diagnosis, and a cutoff value 11 points is more suitable in Chinese patients. Trial registration ClinicalTrials.gov ID: NCT03381131

Feldenkrais awareness though movement intervention for fibromyalgia syndrome: A proof-of-concept study

IntroductionThe Feldenkrais Method® is a form of awareness through movement (ATM) aimed at improving spatial and kinesthetic awareness through verbally guided movements, in order to learn more effective actions. MethodThe present study, a proof-of-concept, observational, non-controlled prospective study, aims at exploring the effectiveness of ATM for fibromyalgia syndrome (FM), measuring the effect by means of multi-dimensional questionnaires, administered at baseline and after 4 months of ATM activity. ResultsOne hundred twenty-eight FM patients (mean age 54 years old, 2% males) participated in the study. A statistically significant improvement was found in FM-specific measures (Polysymptomatic Distress Scale, PDS) (p = 0.003) and the Pain Catastrophization Scale (PCS) (p = 0.020); coherently, the Revised Fibromyalgia Impact Questionnaire (FIQR) showed a trend in improvement after the intervention, although this improvement was not statistically significant. The logistic regression analysis found a correlation between PDS, fatigue and anxiety measures; PCS, years from diagnosis and anxiety. ConclusionATM could improve FM-specific measures and pain-related catastrophizing. Further studies are needed to identify FM subgroups in order to find personalized targets that can be used to guide treatments.

Impact of fibromyalgia and related factors on foot function and quality of life: Cross-sectional study

BackgroundThe aim of study is to examine the factors that may influence pain, disability and the limitation of activity due to the presence of fibromyalgia in the foot. Methods323 patients diagnosed with fibromyalgia were recruited. Each participant completed the Foot Function Index questionnaire (FFI) and the Revised Fibromyalgia Impact Questionnaire (FIQR). A multivariate analysis was performed to determine the factors associated with high scores in each of these questionnaires. ResultsIn both questionnaires, the subscales presenting the highest scores were foot pain (FFI score: 71.18 ± 20.40) and symptom intensity (FIQR score: 36.23 ± 8.04). According to the multivariate analysis, foot function is influenced by age (p = <0.001), BMI (p = 0.001), lack of physical activity (p = <0.001), the presence of rheumatoid arthritis (p = 0.012), retirement due to disability (p = <0.001) and being unemployed (p < 0.001). ConclusionFibromyalgia affects foot function, provoking significant pain. Related factors include age, BMI, lack of physical activity, the presence of rheumatoid arthritis, and employment status.

Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results From the Randomized, Placebo-Controlled RELIEF Trial.

To evaluate the efficacy and safety of TNX-102 SL, a once-nightly sublingual formulation of cyclobenzaprine, in reducing pain in patients with fibromyalgia. RELIEF was a double-blind, randomized, placebo-controlled trial. Overall, 503 patients received TNX-102 SL 2.8 mg for 2 weeks, followed by 5.6 mg for 12 weeks (248 patients), or matching placebo (255 patients). The primary endpoint was change from baseline at week 14 in weekly average of daily pain scores. Secondary endpoints included Patient Global Impression of Change (PGIC) scores, Fibromyalgia Impact Questionnaire Revised (FIQR) scores, Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance and Fatigue scores, and daily sleep quality. Safety was assessed by adverse events (AEs). Reduction in daily pain from baseline at week 14 was significantly greater with TNX-102 SL (LS mean change [95% CI], -1.9 [-2.1 to -1.7]) vs placebo (-1.5 [-1.7 to -1.3]; P=0.01). TNX-102 SL was not associated with significant improvement in PGIC at week 14 but was associated with improvements in FIQR scores, PROMIS scores, and daily sleep quality. Overall, 59.7% of patients receiving TNX-102 SL and 46.3% receiving placebo reported treatment-emergent AEs; the most common were oral hypoesthesia (17.3% with TNX-102 SL vs 0.4% with placebo), oral paresthesia (5.6% vs 0.4%, respectively), and product taste abnormal (4.4% vs 0.4%, respectively). In this phase 3, randomized, controlled trial of patients with fibromyalgia, treatment with TNX-102 SL was associated with significant reductions in daily pain and was safe and well tolerated.

Low-dose naltrexone for treatment of pain in patients with fibromyalgia: a randomized, double-blind, placebo-controlled, crossover study.

Fibromyalgia (FM) is a chronic fluctuating, nociplastic pain condition. Naltrexone is a µ-opioid-receptor antagonist; preliminary studies have indicated a pain-relieving effect of low-dose naltrexone (LDN) in patients with FM. The impetus for studying LDN is the assumption of analgesic efficacy and thus reduction of adverse effects seen from conventional pharmacotherapy. First, to examine if LDN is associated with analgesic efficacy compared with control in the treatment of patients with FM. Second, to ascertain the analgesic efficacy of LDN in an experimental pain model in patients with FM evaluating the competence of the descending inhibitory pathways compared with controls. Third, to examine the pharmacokinetics of LDN. The study used a randomized, double-blind, placebo-controlled, crossover design and had a 3-phase setup. The first phase included baseline assessment and a treatment period (days -3 to 21), the second phase a washout period (days 22-32), and the third phase a baseline assessment followed by a treatment period (days 33-56). Treatment was with either LDN 4.5 mg or an inactive placebo given orally once daily. The primary outcomes were Fibromyalgia Impact Questionnaire revised (FIQR) scores and summed pain intensity ratings (SPIR). Fifty-eight patients with FM were randomized. The median difference (IQR) for FIQR scores between LDN and placebo treatment was -1.65 (18.55; effect size = 0.15; P = 0.3). The median difference for SPIR scores was -0.33 (6.33; effect size = 0.13; P = 0.4). Outcome data did not indicate any clinically relevant analgesic efficacy of the LDN treatment in patients with FM.