Fibromyalgia and Circadian Blood Pressure

NCT ID: NCT05113589

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-07-30

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PBM TREATMENT

REAL PBM TREATMENT

Group Type: EXPERIMENTAL

PBM TREATMENT

Intervention Type: DEVICE

Participants randomized to this treatment will receive a whole body PBM treatment using a NovoTHOR® whole body light bed. For each treatment session, participants will lie supine in the treatment bed for 20 minutes, with no or minimal attire (underwear). Treatment sessions will be three times weekly for a period of 4 weeks, totalling 12 treatment sessions

PLACEBO PBM

PLACEBO PBM TREATMENT

Group Type: PLACEBO_COMPARATOR

PLACEBO PBM

Intervention Type: DEVICE

The placebo feature of the whole body PBM bed provides controls that select active or placebo (sham) treatments in a way undetectable by participant, operator or observers, such that no-one is aware whether the participant is receiving an active or placebo treatment. There is a switch box that randomises participants to active or placebo; no other randomisation is necessary.

Interventions

PBM TREATMENT

Participants randomized to this treatment will receive a whole body PBM treatment using a NovoTHOR® whole body light bed. For each treatment session, participants will lie supine in the treatment bed for 20 minutes, with no or minimal attire (underwear). Treatment sessions will be three times weekly for a period of 4 weeks, totalling 12 treatment sessions

Intervention Type: DEVICE

PLACEBO PBM

The placebo feature of the whole body PBM bed provides controls that select active or placebo (sham) treatments in a way undetectable by participant, operator or observers, such that no-one is aware whether the participant is receiving an active or placebo treatment. There is a switch box that randomises participants to active or placebo; no other randomisation is necessary.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

SANTIAGO NAVARRO LEDESMA

UNIVERSITY PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SANTIAGO NAVARRO-LEDESMA, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Ana González Muñon

Málaga, , Spain

Countries

Spain

Other Identifiers

FMCBP

Identifier Type: -

Identifier Source: org_study_id