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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00010764
Efficacy of Acupuncture in the Treatment of Fibromyalgia
5 de marzo de 2008 actualizado por: National Center for Complementary and Integrative Health (NCCIH)
Fibromyalgia (FM), one of the most common rheumatic conditions, is a condition of unknown etiology characterized by widespread muscle pain and stiffness.
Treatment is generally unsatisfactory and most randomized, controlled treatment trials have been unable to demonstrate a sustained effective intervention.
A single, brief trial of electroacupuncture demonstrated remarkable improvement among patients with FM, although lasting effects were not evaluated.
Nonetheless, the recently published National Institutes of Health Consensus Development Statement on Acupuncture says "musculoskeletal conditions such as fibromyalgia, myofascial pain ....are conditions for which acupuncture may be beneficial".
Thus, 96 patients will be recruited from a referral clinic for fatigue for a 12 week (24 treatments) trial.
These patients will be randomized into 3 control groups and 1 "true" acupuncture group.
The control groups will consist of a group receiving acupuncture treatment for an unrelated condition (morning sickness), a group receiving needle insertion at non-channel, non-point locations, and a "true" placebo group.
This latter group will have acupuncture needle guides tapped on the skin, then needles tapped.
Thus, the specific aims of this study are to 1) evaluate the short and long term efficacy and side effects of a 12 week randomized, controlled trial of bi-weekly acupuncture in the treatment of FM; 2) establish the most useful and scientifically sound control group for studies of acupuncture using FM as a model for conditions characterized by chronic pain; 3) use both subjective and objective measures of overall health and pain to determine the optimal time length of treatment; and 4) examine the concordance of allopathic and acupuncture-based measures of outcome.
For the purposes of this study, subjects will be asked to complete a unique set of study measures at enrollment, at 4, 8, and 12 weeks, and then again at 1 and 6 months post-treatment.
Our primary outcomes will be patient global assessment, subjective pain, and mean number of tender points.
Secondary outcomes will be pain threshold, analgesic use, physician global assessment, functional status, sleep, psychological distress, and fatigue.
Thus, this trial will have both immediate and longer term implications for the scientific study of acupuncture as well as the clinical care of the estimated 5 million patients with FM in the US.
From a methodological point of view, the proposed trial will establish the most appropriate methods for choosing a control group should larger trials be conducted, suggest the optimum duration of treatment, and evaluate the utility of diverse allopathic and alternative outcome measures.
Of equal importance, however, this research will test and potentially establish the effectiveness of acupuncture.
Descripción general del estudio
Descripción detallada
See brief summary
Tipo de estudio
Intervencionista
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Harborview Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Non-pregnant, non-nursing
- Have FM as diagnosed according to the 1990 ACR guidelines at some time but not necessarily currently
- Have a global pain score of >4 on a visual analog scale (VAS, 1=no pain, 10=worst pain)
- Not have another concurrent medical condition associated with significant diffuse neuropathic, musculoskeletal, or joint pain such as diabetic neuropathy, systemic lupus erythematosus, rheumatoid arthritis or severe multi-joint degenerative joint disease
- Not have a history of, or any clinical indication of, a bleeding diathesis
- Not be using narcotics on daily, regular basis
- Not have previously received acupuncture (i.e., be acupuncture naive)
- Not be concurrently participating in any other clinical trials
- Try to stay on a stable medical regiment during the entire course of treatment
- Willing to undergo randomization
- Live within one hour of a treatment site and able to come on a regular basis for treatments
- Not have a pacemaker
- Be able to give consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Debra S. Buchwald, MD, Harborview Injury Prevention and Research Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2000
Finalización del estudio
1 de julio de 2002
Fechas de registro del estudio
Enviado por primera vez
2 de febrero de 2001
Primero enviado que cumplió con los criterios de control de calidad
2 de febrero de 2001
Publicado por primera vez (Estimar)
5 de febrero de 2001
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de marzo de 2008
Última actualización enviada que cumplió con los criterios de control de calidad
5 de marzo de 2008
Última verificación
1 de marzo de 2008
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01AT000003-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .