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

1 dicembre 2014 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

266

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Washington
      • Seattle, Washington, Stati Uniti, 98115
        • University of Washington

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Sperimentale: Exposure therapy (ET)
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
Sperimentale: 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
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Oswestry Disability Index (ODI)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Dennis C. Turk, PhD, University of Washington

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2005

Completamento primario (Effettivo)

1 gennaio 2012

Completamento dello studio (Effettivo)

1 gennaio 2012

Date di iscrizione allo studio

Primo inviato

26 settembre 2008

Primo inviato che soddisfa i criteri di controllo qualità

29 settembre 2008

Primo Inserito (Stima)

30 settembre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 dicembre 2014

Ultimo verificato

1 dicembre 2014

Maggiori informazioni

Termini relativi a questo studio

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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