Trial record 3 of 64 for:    palpitations

Palpitations and Tachycardia in Fibromyalgia Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01147263
First received: June 17, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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 Intervention
Fibromyalgia Syndrome
Other: Evaluation of autonomic parameters

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prevalence and Mechanism of Palpitations and Tachycardia in Fibromyalgia Syndrome

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients diagnosed with Fibromyalgia Other: Evaluation of autonomic parameters
Physical examination, ECG, Loop recorder, Heart rate variability evaluation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147263

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

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

No publications provided

Responsible Party: Jacob N Ablin MD, Tel Aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT01147263     History of Changes
Other Study ID Numbers: TASMC-10-JA-0678-09-CTIL
Study First Received: June 17, 2010
Last Updated: June 17, 2010
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 24, 2014