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1.
Front Pain Res (Lausanne) ; 2: 682072, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-35295526

RESUMEN

Background: Nonrestorative sleep is commonly reported by individuals with fibromyalgia, but there is limited information on the reliability and responsiveness of self-reported sleep measures in this population. Objectives: (1) Examine the reliability and validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep measures in women with fibromyalgia, and (2) Determine the responsiveness of the PROMIS sleep measures to a daily transcutaneous electrical nerve stimulation (TENS) intervention in women with fibromyalgia over 4 weeks compared with other measures of restorative sleep. Methods: In a double-blinded, dual-site clinical trial, 301 women with fibromyalgia were randomly assigned to utilize either Active-TENS, Placebo-TENS, or No-TENS at home. Measures were collected at baseline and after 4 weeks of treatment. To assess self-reported sleep, the participants completed three PROMIS short forms: Sleep Disturbance, Sleep-Related Impairment, Fatigue, and the Pittsburgh Sleep Quality Index (PSQI). To assess device-measured sleep, actigraphy was used to quantify total sleep time, wake after sleep onset, and sleep efficiency. Linear mixed models were used to examine the effects of treatment, time, and treatment*time interactions. Results: The PROMIS short forms had moderate test-retest reliability (ICC 0.62 to 0.71) and high internal consistency (Cronbach's alpha 0.89 to 0.92). The PROMIS sleep measures [mean change over 4 weeks, 95% confidence interval (CI)], Sleep Disturbance: -1.9 (-3.6 to -0.3), Sleep-Related Impairment: -3 (-4.6 to -1.4), and Fatigue: -2.4 (-3.9 to -0.9) were responsive to improvement in restorative sleep and specific to the Active-TENS group but not in the Placebo-TENS [Sleep Disturbance: -1.3 (-3 to 0.3), Sleep-Related Impairment: -1.2 (-2.8 to 0.4), Fatigue: -1.1 (-2.7 to 0.9)] or No-TENS [Sleep Disturbance: -0.1 (-1.6 to 1.5), Sleep-Related Impairment: -0.2 (-1.7 to 1.4), Fatigue: -.3 (-1.8 to 1.2)] groups. The PSQI was responsive but not specific with improvement detected in both the Active-TENS: -0.9 (-1.7 to -0.1) and Placebo-TENS: -0.9 (-1.7 to 0) groups but not in the No-TENS group: -0.3 (-1.1 to 0.5). Actigraphy was not sensitive to any changes in restorative sleep with Active-TENS [Sleep Efficiency: -1 (-2.8 to 0.9), Total Sleep Time: 3.3 (-19.8 to 26.4)]. Conclusion: The PROMIS sleep measures are reliable, valid, and responsive to improvement in restorative sleep in women with fibromyalgia. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT01888640.

2.
Pain ; 162(5): 1545-1555, 2021 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-33230010

RESUMEN

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.


Asunto(s)
Fibromialgia , Estimulación Eléctrica Transcutánea del Nervio , Fatiga/etiología , Fatiga/terapia , Femenino , Fibromialgia/complicaciones , Fibromialgia/terapia , Humanos , Dolor , Dimensión del Dolor
3.
Arthritis Rheumatol ; 72(5): 824-836, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31738014

RESUMEN

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.


Asunto(s)
Fatiga/terapia , Fibromialgia/terapia , Manejo del Dolor/métodos , Estimulación Eléctrica Transcutánea del Nervio , Adulto , Método Doble Ciego , Fatiga/etiología , Femenino , Fibromialgia/complicaciones , Humanos , Persona de Mediana Edad , Movimiento , Dolor/etiología
4.
Psychol Health Med ; 22(5): 552-563, 2017 06.
Artículo en Inglés | MEDLINE | ID: mdl-27216314

RESUMEN

The current study aimed to examine the relationships between movement and resting pain intensity, pain-related distress, and psychological distress in participants scheduled for total knee arthroplasty (TKA). This study examined the impact of anxiety, depression, and pain catastrophizing on the relationship between pain intensity and pain-related distress. Data analyzed for the current study (N = 346) were collected at baseline as part of a larger Randomized Controlled Trial investigating the efficacy of TENS for TKA (TANK Study). Participants provided demographic information, pain intensity and pain-related distress, and completed validated measures of depression, anxiety, and pain catastrophizing. Only 58% of the sample reported resting pain >0 while 92% of the sample reported movement pain >0. Both movement and resting pain intensity correlated significantly with distress (rs = .86, p < .01 and .79, p < .01, respectively). About three quarters to two thirds of the sample (78% for resting pain and 65% for movement pain) reported different pain intensity and pain-related distress. Both pain intensity and pain-related distress demonstrated significant relationships with anxiety, depression, and catastrophizing. Of participants reporting pain, those reporting higher anxiety reported higher levels of distress compared to pain intensity. These findings suggest that anxious patients may be particularly distressed by movement pain preceding TKA. Future research is needed to investigate the utility of brief psychological interventions for pre-surgical TKA patients.


Asunto(s)
Ansiedad/psicología , Artralgia/psicología , Artroplastia de Reemplazo de Rodilla , Catastrofización/psicología , Depresión/psicología , Osteoartritis de la Rodilla/psicología , Estrés Psicológico/psicología , Estimulación Eléctrica Transcutánea del Nervio , Anciano , Artralgia/fisiopatología , Artralgia/terapia , Estudios Transversales , Femenino , Hospitales de Veteranos , Humanos , Masculino , Persona de Mediana Edad , Osteoartritis de la Rodilla/fisiopatología , Osteoartritis de la Rodilla/terapia , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto
5.
Arthritis Res Ther ; 18: 68, 2016 Mar 16.
Artículo en Inglés | MEDLINE | ID: mdl-26979999

RESUMEN

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.


Asunto(s)
Actividades Cotidianas , Dolor Crónico/epidemiología , Fatiga/epidemiología , Fibromialgia/complicaciones , Actividades Cotidianas/psicología , Adulto , Anciano , Dolor Crónico/etiología , Fatiga/etiología , Femenino , Fibromialgia/psicología , Humanos , Modelos Lineales , Persona de Mediana Edad , Percepción , Índice de Severidad de la Enfermedad , Estimulación Eléctrica Transcutánea del Nervio , Adulto Joven
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