Fibromyalgia & Circadian Blood Pressure

Status Completed

Clinical Trial Summary

Fibromyalgia syndrome (FMS) is a chronic and multicomponent illness with unknown etiology and is considered the most frequent cause of diffuse chronic musculoskeletal pain. There is little evidence to confirm if the condition is fully improved after a specific treatment program. Thus a multifactorial understanding of the pathology is crucial to propose new alternative treatments. In this regard, an alteration in circadian blood pressure and persistent nocturnal sympathetic hyperactivity have been shown in patients suffering from fibromyalgia syndrome, leading to malfunctioning in the autonomic nervous system. This is a common pathogenesis shared also by patients with non-dipping blood pressure pattern, which has been closely associated with cardiovascular morbidity. Finally, a significant relationship between fibromyalgia syndrome and non-dipping blood pressure pattern has been shown. Therefore, alterations in circadian blood pressure appear as an additional risk factor in patients with fibromyalgia syndrome, and treatments focus on recovering such blood pressure pattern may be indicated.

Clinical Trial Description

Studying variations of blood pressure is a way of assessing the master circadian clock, through the diurnal/nocturnal BP ratio. When alteration of the circadian rhythm appears, neurohumoral factors that affect autonomic nervous and cardiovascular systems are affected, which presents persistent changes in the blood pressure pattern. These alterations caused by a disturbed circadian rhythm could contribute to the pathogenesis of chronic disorders in general and especially to fibromyalgia syndrome. The aim of the study is to analyze changes in blood pressure and central sensitisation (pain pressure threshold) after a whole-body photobiomodulation treatment in patients suffering from fibromyalgia syndrome, as well as in pain, quality of life and autonomic symptoms. Furthermore, to study the level of association between blood pressure changes and pain perception, quality of life and autonomic symptoms after the end of the treatment. Finally, to study the effects of the treatment 3 months after the end of the treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05113589
Study type	Interventional
Source	University of Malaga
Contact
Status	Completed
Phase	N/A
Start date	February 1, 2021
Completion date	July 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fibromyalgia and Circadian Blood Pressure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms