Blood PressureNCT05113589
Fibromyalgia and Circadian Blood Pressure
A study testing PBM TREATMENT in people with Blood Pressure, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Blood Pressure
- What is being tested?
- PBM TREATMENT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed from FM presenting generalized pain in at least four or five regions.
- Present symptoms for at least 3 months at similar levels.
Who cannot join
- Inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circadian Variation of Blood Pressure in Patients With Fibromyalgia After a Whole Body Photobiomodulation Treatment: a Triple-blinded Randomized Clinical Trial
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.
Read the 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
- Being tested
- PBM TREATMENT, PLACEBO PBM
- Keywords
- blood pressure, autonomic symptoms, pain, fibromyalgia
- Medical subject headings
- Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBM TREATMENTDevice
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 PBMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PBM TREATMENT | Experimental | REAL PBM TREATMENT Receives: Device: PBM TREATMENT |
| PLACEBO PBM | Placebo comparator | PLACEBO PBM TREATMENT Receives: Device: PLACEBO PBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Visual Analogue Scale (VAS) is used by the patient to quantify the pain from 0 (without any pain) to 10 (the worst pain)
Measured: 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
The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score, where higher scores mean a better outcome and lower scores mean a worst outcome. Autonomic nervous system activity provides quantitative information regarding cardiac autonomic tone.
Measured: 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
Tender points will be assessed using a standard pressure algometer (FPK 20; Wagner Instruments, Greenwich, CT, USA.): occiput at the suboccipital muscle insertions, low cervical at the anterior aspects of the intertransverse spaces at C5-C7, trapezius at the midpoint of the upper border, supraspinatus at origins, above the scapula spine near the medial border, paraspinous 3 cm lateral to the midline at the level of the mid-scapula, second rib at the second costochondral junctions, just lateral to the junctions on the upper surfaces, lateral pectoral at the level of the fourth rib at the anterior axillary line, lateral epicondylee 2 cm distal to the epicondyles and medial epicondyle at the epicondyles.
Measured: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
Change from elastography at 3 months
Quantified elastography in tender points. Changes in the status of myofascial trigger-points can be demonstrated with an objective and reproducible USE measure
Measured: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Feb 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SANTIAGO NAVARRO LEDESMA, University of Malaga
- Investigators
- SANTIAGO NAVARRO-LEDESMA, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113589
- Sponsor's protocol ID
- FMCBP
- Status last verified
- Jul 2022
- First submitted
- 28 Oct 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Variation of Blood Pressure in Patients With Fibromyalgia After a Whole Body Photobiomodulation Treatment: a Triple-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05113589
- Acronym / sponsor ID
- FMCBP
- Conditions
- Blood Pressure
- Keywords
- blood pressure, autonomic symptoms, pain, fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM TREATMENT | Experimental | Device: PBM TREATMENTREAL PBM TREATMENT |
| PLACEBO PBM | Placebo comparator | Device: PLACEBO PBMPLACEBO PBM TREATMENT |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed from FM presenting generalized pain in at least four or five regions.
- Present symptoms for at least 3 months at similar levels.
Key exclusion criteria (1 listed)
- Inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBM TREATMENTParticipants 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 | Device | PBM TREATMENT |
| PLACEBO PBMThe 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. | Device | PLACEBO PBM |
Primary outcome
Change of Diurnal/nocturnal blood pressure ratio perceived at three months
Time frame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
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).
4 secondary outcomes
Change from baseline perceived pain at 3 months
Time frame: 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 frame: 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 frame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
Change from elastography at 3 months
Time frame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANTIAGO NAVARRO-LEDESMA, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBM TREATMENT in people with Blood Pressure, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Diurnal/nocturnal blood pressure ratio perceived at three months (time frame: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.