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Fibromyalgia clinical trials

View clinical trials related to Fibromyalgia.

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NCT ID: NCT01631500 Completed - Depression Clinical Trials

Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms

Start date: January 2010
Phase: N/A
Study type: Interventional

Minor mental health problems, MMHP, like mild depression and anxiety, and medically unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead to impaired social and cognitive function and could result in reduced work capacity. The investigators have designed the present study as a pragmatic trial to investigate the effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional treatment in patients with MMHP or MUS in primary care. The investigators examined whether the effects of the integrative treatment model differed from those achieved with therapeutic acupuncture or conventional treatment. Primary endpoints were anxiety and depression (assessed with the Hospital Anxiety and Depression scale), health-related quality of life (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment interventions. Statistical power was calculated based on an expected 50% reduction in HAD anxiety and depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture; and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83% at p <0.05. Treatment effects were calculated as the difference between values at baseline, after four weeks and after the complete intervention period, i.e. after eight weeks. Nonparametric analyses were carried out to test differences between independent samples (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).

NCT ID: NCT01628822 Completed - Fibromyalgia Clinical Trials

Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia

Sophrodol-1
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation. Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption

NCT ID: NCT01621191 Completed - Fibromyalgia Clinical Trials

An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the safety and efficacy of duloxetine in participants with fibromyalgia at long-term use.

NCT ID: NCT01619579 Completed - Fibromyalgia Clinical Trials

Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

AVACEN: TES
Start date: June 2011
Phase: Phase 2
Study type: Interventional

Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain.

NCT ID: NCT01598753 Completed - Fibromyalgia Clinical Trials

Combined Behavioral and Analgesic Trial for Fibromyalgia

COMBAT-FM
Start date: May 2012
Phase: Phase 3
Study type: Interventional

This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls. Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive an inactive pill, called a placebo. There will also be 2 different types of behavioral health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have been recommended for the treatment of patients with FM by the American Pain Society. There are 4 possible study treatment combinations: 1. Tramadol + CBT, 2. Tramadol + HE, 3. Placebo + CBT, 4. Placebo + HE. Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there have been no studies that have evaluated the combination of medication and a behavioral health treatment. The primary purpose of this study is to compare the benefits of the 4 combinations listed.

NCT ID: NCT01598181 Completed - Fibromyalgia Clinical Trials

Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia

Start date: December 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.

NCT ID: NCT01592916 Completed - Fibromyalgia Clinical Trials

Acute Effects of Exercise in Women With Fibromyalgia (FM)

Start date: May 10, 2012
Phase: N/A
Study type: Observational

The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have shown that exercise improves body functions and/or symptom severity in most patients, but not in all. About a third of patients with FM have been shown to have low levels of IGF-1. The purpose of this project is to study individual and biological factors that interact with outcomes of short-term (acute) exercise in FM. Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer bicycle exercise tests will be conducted in feasting patients, separated by one month. The first exercise test is at a low and the second at a high intensity. Measurements comprise blood test, pain rating and pain threshold, conducted before and after the test. The levels of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health status and pain.

NCT ID: NCT01586637 Completed - Fibromyalgia Clinical Trials

Art Therapy to Treat Women With Fibromyalgia

Start date: January 2011
Phase: Phase 2
Study type: Interventional

Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia.

NCT ID: NCT01557062 Completed - Fibromyalgia Clinical Trials

Passive Body Heating, Sleep and Fibromyalgia

Start date: March 2009
Phase: N/A
Study type: Interventional

Objectives: To assess the effect of passive body heating on the sleep pattern of patients with fibromyalgia. Methods: Six menopausal women diagnosed with fibromyalgia according to criteria determined by the American College of Rheumatology were included. All women underwent passive immersion in a warm bath at 36±1 °C, for 15 sessions of 30 minutes each over 3 weeks. Their sleep pattern was assessed by polysomnography at the following conditions: pre-intervention (baseline), on the first day of intervention (acute), on the last day of intervention (chronic) and 3 weeks after the end of interventions (follow-up). Core body temperature was evaluated by a thermistor pill at the above-mentioned conditions. The impact on fibromyalgia was assessed through of a specific questionnaire called fibromyalgia impact questionnaire.

NCT ID: NCT01552057 Completed - Fibromyalgia Clinical Trials

A Study of Duloxetine in Fibromyalgia

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia.