- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147263
Palpitations and Tachycardia in Fibromyalgia Syndrome
June 17, 2010 updated by: Tel-Aviv Sourasky Medical Center
Prevalence and Mechanism of Palpitations and Tachycardia in Fibromyalgia Syndrome
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consecutive patients attending a fibromyalgia clinic, fullfilling ACR 1990 criteria for classification of fibromyalgia
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients diagnosed with Fibromyalgia
|
Physical examination, ECG, Loop recorder, Heart rate variability evaluation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
June 17, 2010
First Submitted That Met QC Criteria
June 17, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Estimate)
June 22, 2010
Last Update Submitted That Met QC Criteria
June 17, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-10-JA-0678-09-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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