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BMJ ; 367: l5654, 2019 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-31619437


OBJECTIVE: To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). DESIGN: Double blind, parallel group, placebo controlled, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. PARTICIPANTS: 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. INTERVENTIONS: Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. MAIN OUTCOME MEASURES: The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. RESULTS: In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was -1.6 (95% confidence interval -3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was -2.3 (-4.2 to-0.4, P=0.02) for patients with type 1 Modic changes and -0.1 (-2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. CONCLUSIONS: In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes. TRIAL REGISTRATION: NCT02323412.

Amoxicilina , Degeneração do Disco Intervertebral/complicações , Deslocamento do Disco Intervertebral/complicações , Dor Lombar , Vértebras Lombares , Adulto , Amoxicilina/administração & dosagem , Amoxicilina/efeitos adversos , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Dor Crônica/diagnóstico , Dor Crônica/tratamento farmacológico , Dor Crônica/etiologia , Avaliação da Deficiência , Método Duplo-Cego , Feminino , Humanos , Dor Lombar/diagnóstico , Dor Lombar/tratamento farmacológico , Dor Lombar/etiologia , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/patologia , Masculino , Pessoa de Meia-Idade , Noruega , Medição da Dor/métodos , Resultado do Tratamento
Sleep ; 38(10): 1607-17, 2015 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-26194577


STUDY OBJECTIVES: Sleep restriction (SR) has been hypothesized to sensitize the pain system. The current study determined whether experimental sleep restriction had an effect on experimentally induced pain and pain-elicited electroencephalographic (EEG) responses. DESIGN: A paired crossover study. INTERVENTION: Pain testing was performed after 2 nights of 50% SR and after 2 nights with habitual sleep (HS). SETTING: Laboratory experiment at research center. PARTICIPANTS: Self-reported healthy volunteers (n = 21, age range: 18-31 y). MEASUREMENTS AND RESULTS: Brief high-density electrical stimuli to the forearm skin produced pinprick-like pain. Subjective pain ratings increased after SR, but only in response to the highest stimulus intensity (P = 0.018). SR increased the magnitude of the pain-elicited EEG response analyzed in the time-frequency domain (P = 0.021). Habituation across blocks did not differ between HS and SR. Event-related desynchronization (ERD) was reduced after SR (P = 0.039). Pressure pain threshold of the trapezius muscle region also decreased after SR (P = 0.017). CONCLUSION: Sleep restriction (SR) increased the sensitivity to pressure pain and to electrically induced pain of moderate, but not low, intensity. The increased electrical pain could not be explained by a difference in habituation. Increased response magnitude is possibly related to reduced processing within the somatosensory cortex after partial SR.

Córtex Cerebral/fisiopatologia , Eletrochoque/efeitos adversos , Dor/fisiopatologia , Privação do Sono/fisiopatologia , Adolescente , Adulto , Estudos Cross-Over , Eletroencefalografia , Feminino , Habituação Psicofisiológica , Voluntários Saudáveis , Humanos , Masculino , Músculo Esquelético/fisiopatologia , Dor/etiologia , Medição da Dor , Limiar da Dor , Pressão/efeitos adversos , Autorrelato , Pele/fisiopatologia , Córtex Somatossensorial/fisiopatologia , Adulto Jovem