Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic
      musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders,
      morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms
      are back pain, headaches, irritable bowel, balance problems and deterioration of physical
      function in general. Patients with fibromyalgia (FM) often show pain at specific points that
      are known as "tender spots or tender spots, with an increased sensitivity to painful stimuli"
      (hyperalgesia) and a decreased pain threshold (allodynia). which can be evidenced in the
      physical examination and in the absence of anomalies that justify in the biological or image
      tests. These pain points to pressure, based on the most specific and specific criteria for
      the diagnosis of the disease, traditionally based on the criteria of the American College of
      Rheumatology (ACR), according to which, should be presented so minus 11 out of 18 painful
      points to confirm it. Although the etiology remains unknown and unclear, its appearance is
      attributed to a problem of central sensitization, that is, changes in central processing,
      which causes an alteration of the mechanisms that regulate the sensation of pain, with
      amplification of nociceptive input . and perpetuation of painful stimuli. Fibromyalgia is
      becoming a common syndrome in the countries of Western Europe, with a prevalence in the
      general population that ranges between 1-3%, and specifically in Spain, around 2.4%. In
      addition, it has a higher incidence in women than men (73-95%), predominantly affecting women
      between the ages of 40-50 years. About 3% of women with fibromyalgia are at an age when
      menopause occurs, so not only do they experience the symptoms of both states but they even
      exacerbate the syndrome with each other. On the other hand, and in relation to its
      chronicity, the care of this type of patients involves large costs for society with a
      significant consumption of health resources in the field of primary care, as well as the
      costs of work absenteeism. For these reasons, it is considered an important problem with a
      great impact on the health system, and therefore more and more studies are being developed
      with the aim of better understanding the pathophysiology of this disease. The therapeutic
      approach includes low cost and easy access measures, such as physical exercise (EF) programs
      to improve the symptoms of FM. Physical exercise has positive effects directly on pain, joint
      and muscle stiffness, generalized sensitivity and fatigue, among others, and secondarily on
      cognitive disorders. Thus, the vast majority of studies focus on low-impact aerobic exercise,
      performed between 60% and 70% of the maximum heart rate two to three times a week. However,
      to date, there is no study that compares the effectiveness of physical exercise with other
      innovative therapeutic actions, such as transcranial magnetic stimulation (TMS), the
      hyperbaric chamber (HBOT), in parameters related to pain and quality of life. the life of
      patients with fibromyalgia. The general objective is the effectiveness of transcranial
      magnetic stimulation and the hyperbaric chamber in women with fibromyalgia. As specific
      objectives we propose:

      To assess the effect of HBOT, TMS and EF on quality of life in women with fibromyalgia.

        -  Object the effect of HBOT, TMS and EF in cortical functioning.

        -  Evaluate the effect of HBOT, TMS and EF on fatigue.

        -  Evaluate the effect of HBOT, TMS and EF on psychological aspects, such as depression and
           anxiety.

        -  Evaluate the effect of HBOT, TMS and EF on the perception of pain and the number of
           painful points.

        -  Evaluate the effect of HBOT, TMS and EF on the quality of sleep.

        -  Evaluate the effect of HBOT, TMS and EF on the quality of life.

        -  Evaluate the effect of HBOT, TMS and EF on the pain constructs.

        -  Determine the effect of HBOT, TMS and EF on plasma endorphin levels.
    


Intervention name(s): Hyperbaric group; Magnetic group; Physical group; Baseline group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants in this group performed 5 sessions per week for 8 weeks (40 sessions in total) . The time of each session is 90 minutes and the chamber pressure is 1.4 ATA with a 100% oxygen mask.; There will be 5 sessions per week for 2 consecutive weeks (10 sessions in total), stimulating the left motor cortex at high frequencies, 10 Hz, for 30 minutes.; A protocol of low-impact physical exercise will be performed twice a week for 8 weeks, with a total of 16 sessions.; This group will be the control group that did not take any action, perform the activities of daily life
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial magnetic stimulation; hyperbaric chamber; pain; endorphins