Fibromyalgia and Circadian Blood Pressure
Condition: Blood Pressure
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

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.
    

Intervention name(s): PBM TREATMENT; PLACEBO PBM
Intervention type(s): Device; Device
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: blood pressure; autonomic symptoms; pain; fibromyalgia