Exploring Associative Pathways and Gender Effects of Racial and Weight Discrimination with Sleep Quality, Physical Activity, and Dietary Behavior in Adults with Higher Body Mass Index and Elevated Cardiovascular Disease Risk [Meeting Abstract]
A Randomized Controlled Trial of TENS for Movement-Evoked Pain in Women with Fibromyalgia
OBJECTIVE:Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. We evaluated if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM. METHODS:Participants were randomly assigned to receive active-TENS (n=103), placebo-TENS (n=99) or no-TENS (n=99) and instructed to use it at home 2h/day during activity for 4- weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome) and fatigue on an 11-point scale before and during application of TENS. Primary and secondary patient-reported outcomes were assessed at randomization and 4weeks. RESULTS:After 4-weeks, the active-TENS group reported a greater reduction in movement-evoked pain and fatigue than placebo-TENS (Pain, Group mean difference(95% CI): -1.0(-1.8, -0.2), p=0.008; Fatigue: -1.4(-2.4, -0.4), p=0.001) and no-TENS groups (Pain: -1.8(-2.6. -1.0), p<0.0001; Fatigue: -1.9(-2.9, -0.9), p=<0.0001). A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001). There were no TENS-related serious adverse events and less than 5% of participants experienced minor adverse events from TENS. CONCLUSION/CONCLUSIONS:Among women with FM and stable medication, 4-weeks of active-TENS use compared with placebo-TENS or no-TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real world, pragmatic setting to establish clinical importance of these findings.
Local Anesthetic Injection Resolves Movement Pain, Motor Dysfunction, and Pain Catastrophizing in Individuals With Chronic Achilles Tendinopathy, a Non-Randomized Clinical Trial
OBJECTIVES/OBJECTIVE:Peripherally-directed treatments (targeted exercise, surgery) can reduce, but not fully eliminate, pain for up to 40% of patients with Achilles tendinopathy. The objectives were to: 1) Identify indicators of altered central processing in participants with Achilles tendinopathy compared to controls; and 2) determine which indicators of altered central processing persisted after a local anesthetic injection in patients with Achilles tendinopathy. DESIGN/METHODS:Mechanistic clinical trial. METHODS:46 adults participated (23 with chronic Achilles tendinopathy, 23 matched-controls; NCT03316378). All participants repeated: 1) movement-evoked pain rating, 2) motor performance, 3) pain psychology questionnaires; 4) quantitative sensory testing. Participants with Achilles tendinopathy received a local anesthetic injection before repeat testing and controls did not. Mixed-effects ANOVAs examined group, time, and group*time effects. RESULTS:>0.05). CONCLUSION/CONCLUSIONS:.
Physical activity is related to function and fatigue but not pain in women with fibromyalgia: baseline analyses from the Fibromyalgia Activity Study with TENS (FAST)
BACKGROUND:Although exercise is an effective treatment for fibromyalgia, the relationships between lifestyle physical activity and multiple symptomology domains of fibromyalgia are not clear. Thus, the purpose of this study was to comprehensively examine the relationships between lifestyle physical activity with multiple outcome domains in women with fibromyalgia, including pain, fatigue, function, pain-related psychological constructs, and quality of life. METHODS:Women (Nâ€‰=â€‰171), aged 20 to 70Â years, diagnosed with fibromyalgia, recruited from an ongoing two-site clinical trial were included in this prespecified subgroup analysis of baseline data. Physical activity was assessed using self-report and accelerometry. Symptomology was assessed using questionnaires of perceived physical function, quality of life, fatigue, pain intensity and interference, disease impact, pain catastrophizing, and fear of movement. In addition, quantitative sensory testing of pain sensitivity and performance-based physical function were assessed. Correlation coefficients, regression analyses and between-group differences in symptomology by activity level were assessed, controlling for age and body mass index (BMI). RESULTS:Lifestyle physical activity was most closely associated with select measures of physical function and fatigue, regardless of age and BMI. Those who performed the lowest levels of lifestyle physical activity had poorer functional outcomes and greater fatigue than those with higher physical activity participation. No relationships between lifestyle physical activity and pain, pain sensitivity, or pain-related psychological constructs were observed. CONCLUSIONS:Lifestyle physical activity is not equally related to all aspects of fibromyalgia symptomology. Lifestyle physical activity levels have the strongest correlations with function, physical quality of life, and movement fatigue in women with fibromyalgia. No relationships between lifestyle physical activity and pain, pain sensitivity, or psychological constructs were observed. These data suggest that physical activity levels are more likely to affect function and fatigue, but have negligible relationships with pain and pain-related psychological constructs, in women with fibromyalgia. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, NCT01888640 . Registered on 28 June 2013.
Meta-analysis of transcutaneous electrical nerve stimulation for relief of spinal pain
We conducted a systematic review and meta-analysis analysing the existing data on transcutaneous electrical nerve stimulation (TENS) or interferential current (IFC) for chronic low back pain (CLBP) and/or neck pain (CNP) taking into account intensity and timing of stimulation, examining pain, function and disability. Seven electronic databases were searched for TENS or IFC treatment in non-specific CLBP or CNP. Four reviewers independently selected randomized controlled trials (RCTs) of TENS or IFC intervention in adult individuals with non-specific CLBP or CNP. Primary outcomes were for self-reported pain intensity and back-specific disability. Two reviewers performed quality assessment, and two reviewers extracted data using a standardized form. Nine RCTs were selected (eight CLBP; one CNP), and seven studies with complete data sets were included for meta-analysis (655 participants). For CLBP, meta-analysis shows TENS/IFC intervention, independent of time of assessment, was significantly different from placebo/control (pÂ <Â 0.02). TENS/IFC intervention was better than placebo/control, during therapy (pÂ =Â 0.02), but not immediately after therapy (pÂ =Â 0.08), or 1-3Â months after therapy (pÂ =Â 0.99). Analysis for adequate stimulation parameters was not significantly different, and there was no effect on disability. This systematic review provides inconclusive evidence of TENS benefits in low back pain patients because the quality of the studies was low, andÂ adequate parameters and timing of assessment were not uniformly used or reported. Without additional high-quality clinical trials usingÂ sufficient sample sizes and adequate parameters and outcome assessments, the outcomes of this review are likely to remain unchanged.
Development of a method to maximize the transcutaneous electrical nerve stimulation intensity in women with fibromyalgia
Introduction/UNASSIGNED:Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention clinically used for pain relief. The importance of utilizing the adequate stimulation intensity is well documented; however, clinical methods to achieve the highest possible intensity are not established. Objectives/UNASSIGNED:Our primary aim was to determine if exposure to the full range of clinical levels of stimulation, from sensory threshold to noxious, would result in higher final stimulation intensities. A secondary aim explored the association of pain, disease severity, and psychological variables with the ability to achieve higher final stimulation intensity. Methods/UNASSIGNED:Women with fibromyalgia (N=143) were recruited for a dual-site randomized controlled trial - Fibromyalgia Activity Study with TENS (FAST). TENS electrodes and stimulation were applied to the lumbar area, and intensity was increased to sensory threshold (ST), then to "strong but comfortable" (SC1), then to "noxious" (N). This was followed by a reduction to the final stimulation intensity of "strong but comfortable" (SC2). We called this the Setting of Intensity of TENS (SIT) test. Results/UNASSIGNED:<0.0001) with a mean increase of 1.7 mA (95% CI: 1.5, 2.2). Linear regression analysis showed that those with the largest increase between SC1 and N had the largest increase in SC2-SC1. Further, those with older age and higher anxiety were able to achieve greater increases in intensity (SC2-SC1) using the SIT test. Conclusion/UNASSIGNED:The SC2-SC1 increase was significantly associated with age and anxiety, with greater mean increases associated with older age and higher anxiety. Thus, although all patients may benefit from this protocol, older women and women with elevated anxiety receive the greatest benefit.
Somatic symptom presentations in women with fibromyalgia are differentially associated with elevated depression and anxiety
This study examined whether depression and anxiety differentially relate to fatigue, sleep disturbance, pain catastrophizing, fear of movement, and pain severity in women with fibromyalgia. Baseline data from the Fibromyalgia Activity Study with Transcutaneous Electrical Nerve Stimulation were analyzed. Of 191 participants, 50â€‰percent reported high anxiety and/or depression (17% high anxiety, 9% high depression, and 24% both). Fatigue and sleep impairment were associated with high depression ( pâ€‰<â€‰0.05). Pain severity, pain catastrophizing, and fear of movement were associated with high anxiety and high depression ( pâ€‰<â€‰0.05). Possible implications for underlying mechanisms and the need for targeted treatments are discussed.
Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia
Objective/UNASSIGNED:The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. Design/UNASSIGNED:Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. Setting/UNASSIGNED:Dual site, university-based outpatient clinics. Subjects/UNASSIGNED:Women aged 20 to 67 years diagnosed with fibromyalgia. Methods/UNASSIGNED:Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. Results/UNASSIGNED:PROMIS static SF instruments had fair to high internal consistency (Cronbach Î±â€‰=â€‰0.58 to 0.94, P â€‰<â€‰0.05). PROMIS 'physical function' domain score was highly correlated with FIQR 'function' score (râ€‰=â€‰-0.73). The PROMIS 'total' score was highly correlated with the FIQR total score (râ€‰=â€‰-0.72). Correlations with FIQR total score of each of the three PROMIS domain scores were râ€‰=â€‰-0.65 for 'physical function,' râ€‰=â€‰-0.63 for 'global,' and râ€‰=â€‰-0.57 for 'symptom' domain. PROMIS 'physical function,' 'global,' and 'symptom' scores explained 58% of the FIQR total score variance. Conclusions/UNASSIGNED:Select PROMIS static SF instruments demonstrate convergent validity with the FIQR, a legacy measure of fibromyalgia disease severity. These results highlight the potential utility of select PROMIS static SFs for assessment and tracking of patient-reported outcomes in fibromyalgia.
The effect of Body Mass Index on Pain Levels of Patients with Fibromyalgia [Meeting Abstract]
Monocyte phenotype is associated with physical activity and pain outcomes in women with fibromyalgia [Meeting Abstract]