- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00000398
Behavioral Treatment of Fibromyalgia
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Fibromyalgia (FM) is characterized by diffuse musculoskeletal pain, discrete tender points at typical soft-tissue sites, fatigue, stiffness, and sleep problems. Of these symptoms, pain is often the primary concern of FM patients and their physicians. Traditional medical approaches to managing FM have limitations (side effects) and have not been effective in managing pain. Given these limitations, treatments that involve nonpharmacologic interventions may represent a valuable addition to patient care. This study will evaluate the effects of two of the most promising nonpharmacologic interventions for FM: coping skills training (CST) for pain management and physical exercise training.
The study is designed to test the hypothesis that an intervention that combines CST and physical exercise training will be more effective than CST or exercise alone. In this study, we will randomly assign each of 180 patients diagnosed with FM to one of four conditions: CST alone, physical exercise training alone, CST plus physical exercise training, or a waiting list control. We will evaluate study participants on four occasions: pre-treatment, post-treatment, 3-month followup, and 6-month followup.
The study will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness, self-effectiveness, and negative pain-related thoughts relate to improvements in pain and disability. Physicians could use this information in matching FM patients to treatment interventions. In addition, our findings may have implications for treatment selection for a broad range of patients suffering from persistent pain.
Tipo di studio
Iscrizione
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Ohio
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Athens, Ohio, Stati Uniti, 45701
- Ohio University
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Columbus, Ohio, Stati Uniti, 43221
- Ohio State University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Complaints of pain persisting for 6 months
- Meet diagnostic criteria for fibromyalgia (American College of Rheumatology criteria)
Exclusion Criteria:
- A significant adverse medical condition that would expose the individual to increased risk of an adverse experience during the course of the trial (e.g. a recent (<6 months) myocardial infarction)
- An abnormal cardiac response to exercise
- Other significant rheumatic disease
- Receiving or applying for disability or compensation benefits because of fibromyalgia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Christopher France, PhD, Ohio University
Pubblicazioni e link utili
Pubblicazioni generali
- Lester, N., and F.J. Keefe. "Coping With Chronic Pain." In Cambridge Handbook of Psychology, Health and Medicine, edited by A. Baum, C. McManus, S. Newman, J. Weinman, and R. West. Cambridge, England: Cambridge University Press, 1997.
- Sandstrom MJ, Keefe FJ. Self-management of fibromyalgia: the role of formal coping skills training and physical exercise training programs. Arthritis Care Res. 1998 Dec;11(6):432-47. doi: 10.1002/art.1790110603.
- Keefe, F.J., France, C. Pain: Biopsychosocial mechanisms and management. Current Directions in Psychological Science 1999; 8:137-141.
- Keefe FJ, Bonk V. Psychosocial assessment of pain in patients having rheumatic diseases. Rheum Dis Clin North Am. 1999 Feb;25(1):81-103. doi: 10.1016/s0889-857x(05)70056-9.
- Keefe FJ, Jacobs M, Underwood-Gordon L. Biobehavioral pain research: a multi-institute assessment of cross-cutting issues and research needs. Clin J Pain. 1997 Jun;13(2):91-103. doi: 10.1097/00002508-199706000-00003.
- Keefe, F.J. "Cognitive Processes and the Pain Experience." In Journal of Musculoskeletal Pain, edited by S.R. Pillemer. 1998; 6:41-45.
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Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01AR044064 (Sovvenzione/contratto NIH degli Stati Uniti)
- NIAMS-032
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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