Palpitations and Tachycardia in Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01147263
Recruitment Status : Unknown
Verified June 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2010
Last Update Posted : June 22, 2010
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
Clinically Characterized by the presence of chronic widespread pan and tenderness, Fibromyalgia (FM) is one of the most common "functional" syndromes. FM is currently conceived of as representing a prototype of central pain, i.e. a condition in which sensitization of the central nervous system results in a overall increase in the processing of painful stimuli, as well as an impairment of pain inhibition. This condition is responsible for significant a social and economic burden and is estimated to affect up to 5% of all women. The 1990 American College of Rheumatology (ACR) classification criteria for FM are the current standard for studying FM, and require the presence of widespread pain lasting over 3 months, as well as documentation of tenderness in at least 11 of 18 pre-defined "tender points. Multiple additional symptoms, which are not part of the classification criteria, include among others sleep disturbances, mood disturbances, cognitive dysfunction, vulvodynia, dysmenorrhea, sexual dysfunction and weight fluctuations. In addition, FM is well known to overlap both clinically and epidemiologically with an ever increasing number of other "functional" disorders, including irritable bowel syndrome (IBS), Temporomandibular joint disorder (TMJD), functional dyspepsia etc. In addition to the central symptom of pain, FM patients frequently complain of non- specific symptoms which are potentially autonomically - mediated. Thus, palpitations, fatigue and inability to stand for long periods of time are all common complaints. About 80-90 percent of FM patients have one or more symptoms associated with autonomic dysfunction. The most common of them is presyncope (62.5%), followed by syncope (12.5%), palpitations on standing (12.5%) and dizziness (12.5%) (14). Some of these symptoms overlap with those of the postural tachycardia syndrome (POTS). POTS is a common dysautonomia, characterized by remarkable increased heart rate during the assumption of the upright posture (>30 bpm). According to our experience, FM is found, at least, in 15% of POTS patients. But, no data exists about the incidence of POTS in patients with FM.The role of the autonomic nervous system (ANS) in initiating and maintaining the syndrome of FM has been studies (and debated) over the last decade. The ANS is an extremely complex system, regulating involuntary body functions, including heart rate, intestinal motility, urination, and sexual activity, among many other variables. Notably, the vagus has an inhibitory effect on pain. Deterioration in the vagal control is "associated" with increased pain sensation. Previous studies have indicated that FM patients may have an increase in sympathetic control over the cardiovascular system with a reciprocal decrease in parasympathetic control. High sympathetic tone is usually associated with a lower threshold to pain. But, the contribution of the ANS to the pathogenesis of FM syndrome remains unclear. Evidently, the ANS interacts with other components of the CNS in the pathogenesis of FM, including pain processing centers in the thalamus and amygdala, as well as with the hypothalamic-pituitary-adrenal (HPA) axis.

Condition or disease Intervention/treatment
Fibromyalgia Syndrome Other: Evaluation of autonomic parameters

Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Prevalence and Mechanism of Palpitations and Tachycardia in Fibromyalgia Syndrome
Study Start Date : July 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Group/Cohort Intervention/treatment
Patients diagnosed with Fibromyalgia Other: Evaluation of autonomic parameters
Physical examination, ECG, Loop recorder, Heart rate variability evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients attending a fibromyalgia clinic, fullfilling ACR 1990 criteria for classification of fibromyalgia

Inclusion Criteria:

  • ACR 1990 criteria for fibromyalgia: widespread pain lasting 3 months
  • Tenderness in 11 of 18 points

Exclusion Criteria:

  • Unable to provide informed concent
  • Known tachyarrhythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01147263

Contact: Jacob N Ablin, MD 972-3-6973668
Contact: Michael Barkagan, MD

Tel Aviv Sourasky medical center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: Jacob N Ablin MD, Tel Aviv Sourasky medical center Identifier: NCT01147263     History of Changes
Other Study ID Numbers: TASMC-10-JA-0678-09-CTIL
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Autonomic dysfunction

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases