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Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.
Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, Geasland KM, Chimenti R, Williams JM, Golchha M, Crofford LJ, Sluka KA
(2020) Arthritis Rheumatol 72: 824-836
MeSH Terms: Adult, Double-Blind Method, Fatigue, Female, Fibromyalgia, Humans, Middle Aged, Movement, Pain, Pain Management, Transcutaneous Electric Nerve Stimulation
Show Abstract · Added March 25, 2020
OBJECTIVE - Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate 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 during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks.
RESULTS - After 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS.
CONCLUSION - Among women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to 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 setting to establish the clinical importance of these findings.
© 2019 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.
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Individualised axitinib regimen for patients with metastatic renal cell carcinoma after treatment with checkpoint inhibitors: a multicentre, single-arm, phase 2 study.
Ornstein MC, Pal SK, Wood LS, Tomer JM, Hobbs BP, Jia XS, Allman KD, Martin A, Olencki T, Davis NB, Gilligan TD, Mortazavi A, Rathmell WK, Garcia JA, Rini BI
(2019) Lancet Oncol 20: 1386-1394
MeSH Terms: Aged, Algorithms, Antineoplastic Agents, Antineoplastic Agents, Immunological, Axitinib, Carcinoma, Renal Cell, Dehydration, Diarrhea, Fatigue, Female, Humans, Hypertension, Ipilimumab, Kidney Neoplasms, Male, Middle Aged, Nivolumab, Progression-Free Survival, Response Evaluation Criteria in Solid Tumors, Retreatment
Show Abstract · Added October 30, 2019
BACKGROUND - Checkpoint inhibitor therapy is a standard of care for patients with metastatic renal cell carcinoma. Treatment options after checkpoint inhibitor therapy include vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitors, although no prospective data regarding their use in this setting exist. Axitinib is a VEGF-R inhibitor with clinical data supporting increased activity with dose titration. We aimed to investigate the activity of dose titrated axitinib in patients with metastatic renal cell carcinoma who were previously treated with checkpoint inhibitor.
METHODS - We did a multicentre, phase 2 trial of axitinib given on an individualised dosing algorithm. Patients at least 18 years of age with histologically or cytologically confirmed locally recurrent or metastatic renal cell carcinoma with clear cell histology, a Karnofsky Performance Status of 70% or more, and measurable disease who received checkpoint inhibitor therapy as the most recent treatment were eligible. There was no limit on number of previous therapies received. Patients received oral axitinib at a starting dose of 5 mg twice daily with dose titration every 14 days in 1 mg increments (ie, 5 mg twice daily to 6 mg twice daily, up to 10 mg twice daily maximum dose) if there was no axitinib-related grade 2 or higher mucositis, diarrhoea, hand-foot syndrome, or fatigue. If one or more of these grade 2 adverse events occurred, axitinib was withheld for 3 days before the same dose was resumed. Dose reductions were made if recurrent grade 2 adverse events despite treatment breaks or grade 3-4 adverse events occurred. The primary outcome was progression-free survival. Analyses were done per protocol in all patients who received at least one dose of axitinib. Recruitment has been completed and the trial is ongoing. This trial is registered with ClincalTrials.gov, number NCT02579811.
FINDINGS - Between Jan 5, 2016 and Feb 21, 2018, 40 patients were enrolled and received at least one dose of study treatment. With a median follow-up of 8·7 months (IQR 3·7-14·2), the median progression-free survival was 8·8 months (95% CI 5·7-16·6). Fatigue (83%) and hypertension (75%) were the most common all-grade adverse events. The most common grade 3 adverse event was hypertension (24 patients [60%]). There was one (3%) grade 4 adverse event (elevated lipase) and no treatment-related deaths occurred. Serious adverse events that were likely related to therapy occurred in eight (20%) patients; the most common were dehydration (n=4) and diarrhoea (n=2).
INTERPRETATION - Individualised axitinib dosing in patients with metastatic renal cell inoma previously treated with checkpoint inhibitors did not meet the prespecified threshold for progression free survival, but these data show that this individualised titration scheme is feasible and has robust clinical activity. These prospective results warrant consideration of axitinib in this setting.
FUNDING - Pfizer.
Copyright © 2019 Elsevier Ltd. All rights reserved.
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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).
Merriwether EN, Frey-Law LA, Rakel BA, Zimmerman MB, Dailey DL, Vance CGT, Golchha M, Geasland KM, Chimenti R, Crofford LJ, Sluka KA
(2018) Arthritis Res Ther 20: 199
MeSH Terms: Adult, Aged, Double-Blind Method, Exercise, Fatigue, Female, Fibromyalgia, Humans, Middle Aged, Pain, Pain Measurement, Quality of Life, Surveys and Questionnaires, Transcutaneous Electric Nerve Stimulation, Treatment Outcome, Young Adult
Show Abstract · Added March 25, 2020
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 (N = 171), aged 20 to 70 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 - ClinicalTrials.gov, NCT01888640 . Registered on 28 June 2013.
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Noise-induced cochlear synaptopathy in rhesus monkeys (Macaca mulatta).
Valero MD, Burton JA, Hauser SN, Hackett TA, Ramachandran R, Liberman MC
(2017) Hear Res 353: 213-223
MeSH Terms: Animals, Auditory Fatigue, Auditory Threshold, Cochlea, Cochlear Diseases, Disease Models, Animal, Evoked Potentials, Auditory, Brain Stem, Hair Cells, Auditory, Hearing, Hearing Loss, Noise-Induced, Macaca mulatta, Noise, Otoacoustic Emissions, Spontaneous, Synapses, Synaptic Transmission, Time Factors
Show Abstract · Added April 3, 2018
Cochlear synaptopathy can result from various insults, including acoustic trauma, aging, ototoxicity, or chronic conductive hearing loss. For example, moderate noise exposure in mice can destroy up to ∼50% of synapses between auditory nerve fibers (ANFs) and inner hair cells (IHCs) without affecting outer hair cells (OHCs) or thresholds, because the synaptopathy occurs first in high-threshold ANFs. However, the fiber loss likely impairs temporal processing and hearing-in-noise, a classic complaint of those with sensorineural hearing loss. Non-human primates appear to be less vulnerable to noise-induced hair-cell loss than rodents, but their susceptibility to synaptopathy has not been studied. Because establishing a non-human primate model may be important in the development of diagnostics and therapeutics, we examined cochlear innervation and the damaging effects of acoustic overexposure in young adult rhesus macaques. Anesthetized animals were exposed bilaterally to narrow-band noise centered at 2 kHz at various sound-pressure levels for 4 h. Cochlear function was assayed for up to 8 weeks following exposure via auditory brainstem responses (ABRs) and otoacoustic emissions (OAEs). A moderate loss of synaptic connections (mean of 12-27% in the basal half of the cochlea) followed temporary threshold shifts (TTS), despite minimal hair-cell loss. A dramatic loss of synapses (mean of 50-75% in the basal half of the cochlea) was seen on IHCs surviving noise exposures that produced permanent threshold shifts (PTS) and widespread hair-cell loss. Higher noise levels were required to produce PTS in macaques compared to rodents, suggesting that primates are less vulnerable to hair-cell loss. However, the phenomenon of noise-induced cochlear synaptopathy in primates is similar to that seen in rodents.
Copyright © 2017 Elsevier B.V. All rights reserved.
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Association of Muscle Endurance, Fatigability, and Strength With Functional Limitation and Mortality in the Health Aging and Body Composition Study.
Roshanravan B, Patel KV, Fried LF, Robinson-Cohen C, de Boer IH, Harris T, Murphy RA, Satterfield S, Goodpaster BH, Shlipak M, Newman AB, Kestenbaum B, Health ABC study
(2017) J Gerontol A Biol Sci Med Sci 72: 284-291
MeSH Terms: Aged, Aged, 80 and over, Body Composition, Female, Humans, Lower Extremity, Male, Mobility Limitation, Muscle Fatigue, Muscle Strength, Physical Endurance
Show Abstract · Added September 19, 2017
BACKGROUND - Mobility limitation is highly prevalent among older adults and is central to the loss of functional independence. Dynamic isokinetic muscle fatigue testing may reveal increased vulnerability to disability and mortality beyond strength testing.
METHODS - We studied community-dwelling older adults enrolled in the Health Aging and Body Composition study (age range: 71-82) free of mobility disability and who underwent isokinetic muscle fatigue testing in 1999-2000 (n = 1,963). Isokinetic quadriceps work and fatigue index was determined over 30 repetitions and compared with isometric quadriceps maximum torque. Work was normalized to leg lean mass accounting for gender-specific differences (specific work). The primary outcome was incident persistent severe lower extremity limitation (PSLL), defined as two consecutive reports of either having a lot of difficulty or being unable to walk 1/4 mile or climb 10 steps without resting. The secondary outcome was all-cause mortality.
RESULTS - There were 608 (31%) occurrences of incident PSLL and 488 (25%) deaths during median follow-up of 9.3 years. After adjustment, lower isokinetic work was associated with significantly greater risks of PSLL and mortality across the full measured range. Hazard ratios per standard deviation lower specific isokinetic work were 1.22 (95% CI 1.12, 1.33) for PSLL and 1.21 (95% CI 1.13, 1.30) for mortality, respectively. Lower isometric strength was associated with PSLL, but not mortality. Fatigue index was not associated with PSLL or mortality.
CONCLUSIONS - Muscle endurance, estimated by isokinetic work, is an indicator of muscle health associated with mobility limitation and mortality providing important insight beyond strength testing.
© The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Perceived function and physical performance are associated with pain and fatigue in women with fibromyalgia.
Dailey DL, Frey Law LA, Vance CG, Rakel BA, Merriwether EN, Darghosian L, Golchha M, Geasland KM, Spitz R, Crofford LJ, Sluka KA
(2016) Arthritis Res Ther 18: 68
MeSH Terms: Activities of Daily Living, Adult, Aged, Chronic Pain, Fatigue, Female, Fibromyalgia, Humans, Linear Models, Middle Aged, Perception, Severity of Illness Index, Transcutaneous Electric Nerve Stimulation, Young Adult
Show Abstract · Added March 25, 2020
BACKGROUND - Fibromyalgia is a condition characterized by chronic widespread muscle pain and fatigue and associated with significant impairment in perceived function and reduced physical performance. The purpose of this study was to determine the degree to which pain and fatigue are associated with perceived function and physical performance in women with fibromyalgia.
METHODS - Hierarchical linear regression determined the contribution of pain and fatigue (Numeric Rating Scale (NRS) for resting, movement and combined) to perceived function (Fibromyalgia Impact Questionnaire Revised - Function Subscale, FIQR-Function), Multidimensional Assessment of Fatigue - Activities of Daily Living (MAF-ADL) and SF-36 Physical Function Subscale (SF-36-PF) and physical performance (6-Minute Walk Test, 6MWT and Five Time Sit To Stand, 5TSTS) while controlling for age, body mass index, pain catastrophizing, fear of movement, anxiety, and depression in women with fibromyalgia (N = 94).
RESULTS - For perceived function, movement pain and movement fatigue together better predicted FIQR-function (adjusted R(2) = 0.42, p ≤ 0.001); MAF-ADL (adjusted R(2) = 0.41, p ≤ 0.001); and SF-36-PF function (adjusted R(2) = 0.34, p ≤ 0.001). For physical performance measures, movement pain and fatigue together predicted 6MWT distance (adjusted R(2) = 0.42, p ≤ 0.001) and movement fatigue alone predicted performance time on the 5TSTS (adjusted R(2) = 0.20, p ≤ 0.001).
CONCLUSIONS - Pain and fatigue are significantly associated with and explain more than one-third of the variance in perceived function and physical performance in women with fibromyalgia.
TRIAL REGISTRATION - NIH Clinicaltrials.gov
REGISTRATION - NCT01888640 . Registered 13 June 2013.
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Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial.
Noehren B, Dailey DL, Rakel BA, Vance CG, Zimmerman MB, Crofford LJ, Sluka KA
(2015) Phys Ther 95: 129-40
MeSH Terms: Double-Blind Method, Fatigue, Female, Fibromyalgia, Humans, Pain Measurement, Quality of Life, Transcutaneous Electric Nerve Stimulation
Show Abstract · Added January 21, 2015
BACKGROUND - Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.
OBJECTIVES - The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.
DESIGN - This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.
PARTICIPANTS - Three hundred forty-three participants with fibromyalgia will be recruited for this study.
INTERVENTION - Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.
MEASUREMENTS - The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.
LIMITATIONS - Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.
CONCLUSIONS - The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.
© 2015 American Physical Therapy Association.
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Survivorship: cognitive function, version 1.2014.
Denlinger CS, Ligibel JA, Are M, Baker KS, Demark-Wahnefried W, Friedman DL, Goldman M, Jones L, King A, Ku GH, Kvale E, Langbaum TS, Leonardi-Warren K, McCabe MS, Melisko M, Montoya JG, Mooney K, Morgan MA, Moslehi JJ, O'Connor T, Overholser L, Paskett ED, Raza M, Syrjala KL, Urba SG, Wakabayashi MT, Zee P, McMillian NR, Freedman-Cass DA, National Comprehensive Cancer Network
(2014) J Natl Compr Canc Netw 12: 976-86
MeSH Terms: Adaptation, Psychological, Benzhydryl Compounds, Brain Neoplasms, Central Nervous System Stimulants, Cognition Disorders, Fatigue, Humans, Methylphenidate, Modafinil, Occupational Therapy, Pain Management, Quality of Life, Sleep Wake Disorders, Survival Rate, Treatment Outcome, Wakefulness-Promoting Agents
Show Abstract · Added May 29, 2020
Cognitive impairment is a common complaint among cancer survivors and may be a consequence of the tumors themselves or direct effects of cancer-related treatment (eg, chemotherapy, endocrine therapy, radiation). For some survivors, symptoms persist over the long term and, when more severe, can impact quality of life and function. This section of the NCCN Guidelines for Survivorship provides assessment, evaluation, and management recommendations for cognitive dysfunction in survivors. Nonpharmacologic interventions (eg, instruction in coping strategies; management of distress, pain, sleep disturbances, and fatigue; occupational therapy) are recommended, with pharmacologic interventions as a last line of therapy in survivors for whom other interventions have been insufficient.
Copyright © 2014 by the National Comprehensive Cancer Network.
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Survivorship: fatigue, version 1.2014.
Denlinger CS, Ligibel JA, Are M, Baker KS, Demark-Wahnefried W, Friedman DL, Goldman M, Jones L, King A, Ku GH, Kvale E, Langbaum TS, Leonardi-Warren K, McCabe MS, Melisko M, Montoya JG, Mooney K, Morgan MA, Moslehi JJ, O'Connor T, Overholser L, Paskett ED, Raza M, Syrjala KL, Urba SG, Wakabayashi MT, Zee P, McMillian N, Freedman-Cass D
(2014) J Natl Compr Canc Netw 12: 876-87
MeSH Terms: Fatigue, Humans, Motor Activity, Neoplasms, Patient Education as Topic, Survival Rate
Show Abstract · Added May 29, 2020
Many cancer survivors report that fatigue is a disruptive symptom even after treatment ends. Persistent cancer-related fatigue affects quality of life, because individuals become too tired to fully participate in the roles and activities that make life meaningful. Identification and management of fatigue remains an unmet need for many cancer survivors. This section of the NCCN Guidelines for Survivorship provides screening, evaluation, and management recommendations for fatigue in survivors. Management includes education and counseling, physical activity, psychosocial interventions, and pharmacologic treatments.
Copyright © 2014 by the National Comprehensive Cancer Network.
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AMPK controls exercise endurance, mitochondrial oxidative capacity, and skeletal muscle integrity.
Lantier L, Fentz J, Mounier R, Leclerc J, Treebak JT, Pehmøller C, Sanz N, Sakakibara I, Saint-Amand E, Rimbaud S, Maire P, Marette A, Ventura-Clapier R, Ferry A, Wojtaszewski JF, Foretz M, Viollet B
(2014) FASEB J 28: 3211-24
MeSH Terms: AMP-Activated Protein Kinases, Animals, Glucose, Interleukin-6, Male, Mice, Mice, Inbred C57BL, Mice, Knockout, Mitochondria, Muscle Contraction, Muscle Fatigue, Muscle Fibers, Skeletal, Oxidation-Reduction, Phosphorylation, Physical Conditioning, Animal, Physical Endurance
Show Abstract · Added April 17, 2014
AMP-activated protein kinase (AMPK) is a sensor of cellular energy status that plays a central role in skeletal muscle metabolism. We used skeletal muscle-specific AMPKα1α2 double-knockout (mdKO) mice to provide direct genetic evidence of the physiological importance of AMPK in regulating muscle exercise capacity, mitochondrial function, and contraction-stimulated glucose uptake. Exercise performance was significantly reduced in the mdKO mice, with a reduction in maximal force production and fatigue resistance. An increase in the proportion of myofibers with centralized nuclei was noted, as well as an elevated expression of interleukin 6 (IL-6) mRNA, possibly consistent with mild skeletal muscle injury. Notably, we found that AMPKα1 and AMPKα2 isoforms are dispensable for contraction-induced skeletal muscle glucose transport, except for male soleus muscle. However, the lack of skeletal muscle AMPK diminished maximal ADP-stimulated mitochondrial respiration, showing an impairment at complex I. This effect was not accompanied by changes in mitochondrial number, indicating that AMPK regulates muscle metabolic adaptation through the regulation of muscle mitochondrial oxidative capacity and mitochondrial substrate utilization but not baseline mitochondrial muscle content. Together, these results demonstrate that skeletal muscle AMPK has an unexpected role in the regulation of mitochondrial oxidative phosphorylation that contributes to the energy demands of the exercising muscle.-Lantier, L., Fentz, J., Mounier, R., Leclerc, J., Treebak, J. T., Pehmøller, C., Sanz, N., Sakakibara, I., Saint-Amand, E., Rimbaud, S., Maire, P., Marette, A., Ventura-Clapier, R., Ferry, A., Wojtaszewski, J. F. P., Foretz, M., Viollet, B. AMPK controls exercise endurance, mitochondrial oxidative capacity, and skeletal muscle integrity.
© FASEB.
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