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Fibromyalgia and Circadian Blood Pressure

U

University of Malaga

Status

Completed

Conditions

Blood Pressure

Treatments

Device: PLACEBO PBM
Device: PBM TREATMENT

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

PBM TREATMENT
Experimental group
Description:
REAL PBM TREATMENT
Treatment:
Device: PBM TREATMENT
PLACEBO PBM
Placebo Comparator group
Description:
PLACEBO PBM TREATMENT
Treatment:
Device: PLACEBO PBM

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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