Clinical trial NCT05113589: Fibromyalgia and Circadian Blood Pressure
Official title: Circadian Variation of Blood Pressure in Patients With Fibromyalgia After a Whole Body Photobiomodulation Treatment: a Triple-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: blood pressure
autonomic symptoms
pain
fibromyalgia
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed from FM presenting generalized pain in at least four or five regions.
* Present symptoms for at least 3 months at similar levels.

Exclusion Criteria:

* Inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.

Primary outcomes:
measure: Change of Diurnal/nocturnal blood pressure ratio perceived at three months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
Secondary outcomes:
measure: Change from baseline perceived pain at 3 months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
measure: Change from autonomic nervous system activity at 3 months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
measure: Change from baseline Pain pressure threshold at 3 months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
measure: Change from elastography at 3 months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Ana González Muñon
Study officials:
affiliation: Universidad de Granada
name: SANTIAGO NAVARRO-LEDESMA, PhD
role: PRINCIPAL_INVESTIGATOR
References: