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Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment

1 décembre 2014 mis à jour par: Dennis Turk, University of Washington
Fibromyalgia syndrome (FMS) refers to a set of symptoms that include exhaustion, muscle pain, and tender points, where slight pressure can cause pain. Doctors do not know what causes FMS or how to cure it, but some treatments have helped relieve its symptoms. Progressive exercise, in which exercise is started at low levels and then increased, is one of the most reliable treatments, but people with FMS often avoid exercise or stop after completing exercise programs. This research will focus on the idea that people with FMS do not exercise because they are afraid of injury or have had a negative experience exercising. Participants will undergo one or a combination of several different treatments that aim to reduce fear of exercising. The different treatments will then be evaluated on their effectiveness in reducing disability among people with FMS.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Fibromyalgia syndrome (FMS) is a condition without a known cause or cure. Differing theories place the blame on abnormal sensitivity to pain receptors in the brain, changes in metabolism and hormones, abnormalities in the autonomic nervous system, sleep disturbances, infection, or injury. A diagnosis of FMS, therefore, is based on a set of symptoms. These include pain in muscles, ligaments, and tendons; fatigue; and multiple tender points on the body, where even slight pressure causes pain.

Although there is no cure, FMS can be treated to reduce the severity or presence of symptoms. One of the most reliable ways to do this is through progressive exercise, which involves starting at low levels of exercise and building up to longer and more strenuous levels. Despite the benefit of exercise, FSM sufferers often drop out of supervised exercise programs or discontinue exercise once they are no longer supervised. Some FMS patients may have a fear-based avoidance of exercise, believing it will provoke pain or deterioration of their condition and experiencing significant negative emotional arousal when they exercise. This may be due to a prior painful or uncomfortable experience while exercising.

This study will employ multiple treatments that are usually used for treatment of phobias and will aim to reduce fear, increase exercising, and improve FMS symptoms. Under the purview of cognitive behavioral therapy (CBT) are multiple types of treatments. Cognitive restructuring (CR) and coping skills training (ST) paired together address maladaptive beliefs and facilitate the development of more effective coping strategies. Exposure therapy (ET) reduces the level of emotional arousal when patients are exposed to the feared stimulus, in this case exercising. Attention control (AC) treatment, not a type of CBT, provides patients with support and controls for nonspecific factors related to exposure to their feared stimulus. AC will be used as the control treatment in this study.

Participation in this study will last 4 months. After recruitment and an initial evaluation, participants will be placed on a waiting list for 8 weeks to determine whether their symptoms improve or change naturally. They will then be reassessed and randomly assigned to one of the following groups for 8 weeks of treatment:

  1. CR+ST: This group will help participants develop adaptive ways of thinking and acting to alter maladaptive beliefs in general and beliefs about certain exercises in specific.
  2. ET: This group will help participants to decrease their fear response during specific exercises through progressive, controlled exposure to the feared stimulus.
  3. COMB: This group will combine CR+ST and ET treatment plans so that adaptive thoughts and behaviors will be emphasized in the first 4 weeks, and exposure to feared stimuli will be emphasized in the second 4 weeks.
  4. AC: This group will offer participants non-directive, supportive counseling. Each treatment group will meet in weekly 90-minute group sessions for the first 4 weeks and in weekly 60-minute individual sessions for the second 4 weeks. Participants will have 60-minute physical therapy sessions accompanying every treatment session. Participants will also be given weekly homework assignments specific to their treatment group.

Participants will undergo a series of assessments that include self-report measures, medical and psychological evaluations, and a physical capability evaluation by a physical trainer. These assessments will be performed at recruitment, after the 8-week waiting period, after treatment, at 1- and 3-month mail and telephone follow-ups, and at a 6-month follow-up in the treatment clinic. They will assess fear, health, physical ability, and psychological health.

Type d'étude

Interventionnel

Inscription (Réel)

266

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Washington
      • Seattle, Washington, États-Unis, 98115
        • University of Washington

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Meet American College of Rheumatology (ACR) criteria for the diagnosis of fibromyalgia
  • Able to comply with functional assessment and treadmill exercise

Exclusion Criteria:

  • History of psychiatric hospitalization, suicide attempt, or significant problems with chemical dependency during the 6 months prior to enrollment in the study
  • Evidence of severe psychiatric disorder that would prevent participation
  • Medical conditions, such as significant cardiac disease, that make it medically unsuitable for participation in a progressive exercise program
  • A medical condition, such as multiple sclerosis, that has a high likelihood of obscuring effects of the experimental treatments
  • Anxiety or mood disorders in which symptoms are severe enough to prevent participation

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cognitive restructuring and coping skills training (CR+ST)
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
Expérimental: Exposure therapy (ET)
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
Expérimental: Combination (COMB) treatment
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
Comparateur actif: Attention control (AC) treatment
Provides support and controls for nonspecific factors associated with exposure to therapists and other FMS sufferers, but does not directly address either maladaptive beliefs or emotional arousal

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Oswestry Disability Index (ODI)
Délai: Measured at the initial evaluation; after 8 weeks on a waiting list; immediately after treatment; and 1, 3, and 6 months after treatment
Measured at the initial evaluation; after 8 weeks on a waiting list; immediately after treatment; and 1, 3, and 6 months after treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Dennis C. Turk, PhD, University of Washington

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2005

Achèvement primaire (Réel)

1 janvier 2012

Achèvement de l'étude (Réel)

1 janvier 2012

Dates d'inscription aux études

Première soumission

26 septembre 2008

Première soumission répondant aux critères de contrôle qualité

29 septembre 2008

Première publication (Estimation)

30 septembre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 décembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 décembre 2014

Dernière vérification

1 décembre 2014

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur CR+ST

3
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