Fibromyalgia and Circadian Blood Pressure

NCT05113589 | Completed DMC

• 1 other identifier: FMCBP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

blood pressure; autonomic symptoms; pain; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change of Diurnal/nocturnal blood pressure ratio perceived at three months

  The diurnal/nocturnal blood pressure ratio is defined as the nocturnal decline in BP relative to the diurnal blood pressure mean, and it is calculated as 100×(mean diurnal blood pressure-mean nocturnal blood pressure)/mean diurnal blood pressure. Mean blood pressure is calculated by mean blood pressure = diastolic pressure + 1/3 (systolic pressure - diastolic pressure). There are four possible groups: extreme-dippers (diurnal/nocturnal BP ratio ≥20%), normal dippers (ratio ≥10%), non-dippers (ratio \<10%), and inverse-dippers or risers (ratio \<0%, indicating nocturnal BP above the diurnal mean).

  time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)

Secondary Outcomes (4)

• Change from baseline perceived pain at 3 months

  time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)

• Change from autonomic nervous system activity at 3 months

  time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)

• Change from baseline Pain pressure threshold at 3 months

  time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)

• Change from elastography at 3 months

  time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)

Study Arms (2)

PBM TREATMENT

EXPERIMENTAL

REAL PBM TREATMENT

Device: PBM TREATMENT

PLACEBO PBM

PLACEBO COMPARATOR

PLACEBO PBM TREATMENT

Device: PLACEBO PBM

Interventions

PBM TREATMENT 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

PBM TREATMENT

PLACEBO PBM 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.

PLACEBO PBM

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Ana González Muñon

Málaga, Spain

Location

MeSH Terms

Conditions

Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• SANTIAGO NAVARRO-LEDESMA, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIVERSITY PROFESSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: February 1, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

ES (1)