<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03801109</url>
  </required_header>
  <id_info>
    <org_study_id>H1548771544856</org_study_id>
    <nct_id>NCT03801109</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia</brief_title>
  <official_title>Study of the Effectiveness of Transcranial Magnetic Stimulation and the Hyperbaric Chamber in Women With Fibromyalgia. Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic&#xD;
      musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders,&#xD;
      morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms&#xD;
      are back pain, headaches, irritable bowel, balance problems and deterioration of physical&#xD;
      function in general. Patients with fibromyalgia (FM) often show pain at specific points that&#xD;
      are known as &quot;tender spots or tender spots, with an increased sensitivity to painful stimuli&quot;&#xD;
      (hyperalgesia) and a decreased pain threshold (allodynia). which can be evidenced in the&#xD;
      physical examination and in the absence of anomalies that justify in the biological or image&#xD;
      tests. These pain points to pressure, based on the most specific and specific criteria for&#xD;
      the diagnosis of the disease, traditionally based on the criteria of the American College of&#xD;
      Rheumatology (ACR), according to which, should be presented so minus 11 out of 18 painful&#xD;
      points to confirm it. Although the etiology remains unknown and unclear, its appearance is&#xD;
      attributed to a problem of central sensitization, that is, changes in central processing,&#xD;
      which causes an alteration of the mechanisms that regulate the sensation of pain, with&#xD;
      amplification of nociceptive input . and perpetuation of painful stimuli. Fibromyalgia is&#xD;
      becoming a common syndrome in the countries of Western Europe, with a prevalence in the&#xD;
      general population that ranges between 1-3%, and specifically in Spain, around 2.4%. In&#xD;
      addition, it has a higher incidence in women than men (73-95%), predominantly affecting women&#xD;
      between the ages of 40-50 years. About 3% of women with fibromyalgia are at an age when&#xD;
      menopause occurs, so not only do they experience the symptoms of both states but they even&#xD;
      exacerbate the syndrome with each other. On the other hand, and in relation to its&#xD;
      chronicity, the care of this type of patients involves large costs for society with a&#xD;
      significant consumption of health resources in the field of primary care, as well as the&#xD;
      costs of work absenteeism. For these reasons, it is considered an important problem with a&#xD;
      great impact on the health system, and therefore more and more studies are being developed&#xD;
      with the aim of better understanding the pathophysiology of this disease. The therapeutic&#xD;
      approach includes low cost and easy access measures, such as physical exercise (EF) programs&#xD;
      to improve the symptoms of FM. Physical exercise has positive effects directly on pain, joint&#xD;
      and muscle stiffness, generalized sensitivity and fatigue, among others, and secondarily on&#xD;
      cognitive disorders. Thus, the vast majority of studies focus on low-impact aerobic exercise,&#xD;
      performed between 60% and 70% of the maximum heart rate two to three times a week. However,&#xD;
      to date, there is no study that compares the effectiveness of physical exercise with other&#xD;
      innovative therapeutic actions, such as transcranial magnetic stimulation (TMS), the&#xD;
      hyperbaric chamber (HBOT), in parameters related to pain and quality of life. the life of&#xD;
      patients with fibromyalgia. The general objective is the effectiveness of transcranial&#xD;
      magnetic stimulation and the hyperbaric chamber in women with fibromyalgia. As specific&#xD;
      objectives we propose:&#xD;
&#xD;
      To assess the effect of HBOT, TMS and EF on quality of life in women with fibromyalgia.&#xD;
&#xD;
        -  Object the effect of HBOT, TMS and EF in cortical functioning.&#xD;
&#xD;
        -  Evaluate the effect of HBOT, TMS and EF on fatigue.&#xD;
&#xD;
        -  Evaluate the effect of HBOT, TMS and EF on psychological aspects, such as depression and&#xD;
           anxiety.&#xD;
&#xD;
        -  Evaluate the effect of HBOT, TMS and EF on the perception of pain and the number of&#xD;
           painful points.&#xD;
&#xD;
        -  Evaluate the effect of HBOT, TMS and EF on the quality of sleep.&#xD;
&#xD;
        -  Evaluate the effect of HBOT, TMS and EF on the quality of life.&#xD;
&#xD;
        -  Evaluate the effect of HBOT, TMS and EF on the pain constructs.&#xD;
&#xD;
        -  Determine the effect of HBOT, TMS and EF on plasma endorphin levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">June 26, 2020</completion_date>
  <primary_completion_date type="Actual">December 23, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in pain intensity</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: change from baseline in the intensity of pain at 8 weeks. Magnetic group: change from baseline in the intensity of pain at 3 weeks.</time_frame>
    <description>Analog visual scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rating of pain</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. Interpretation : 0 minimum pain score and 78 maximum pain score. The higher the pain score the greater the pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain catastrophizing</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>it will be measurde by pain catastrophizing scale. It is a Self-administered scale on a 5-point Likert scale ranging from 0 (never) to 4 (always), which are distributed in 3 subscales: rumination (refers to a state or feeling of constant worry and the inability to inhibit thoughts related to pain), despair (manifested when hope has been lost for achieving something, or because it disappears or because it gives off some physical and / or psychological aspect that is detrimental to health) and magnification (refers to the exaggeration of unpleasant situations of pain and expectations of negative consequences). Higher scores indicate higher levels of catastrophism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of pain</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The Chronic Pain Acceptance Questionnaire (CPAQ) is a 20-item inventory designed to measure acceptance of pain. here are two principle factors measured by this questionnaire: activities engagement and pain willingness. All items are rated on a 0 (never true) to 6 (always true) scale. The maximum possible total score is 120, with a higher score indicating better acceptance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain self perception</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The Pain Self-Perception Scale (PSPS) is a 24-item questionnaire used to assess mental defeat in chronic pain patients. espondents are asked to indicate to what extent each of the 24 statements applied to their experience &quot;during a recent episode of intense pain&quot;. These statements are to be rated on a 5-point scale (0 = &quot;Not at all/Never,&quot; 1 = &quot;Very little,&quot; 2 = &quot;Moderately,&quot; 3 = &quot;Strongly,&quot; 4 = &quot;Very strongly&quot;), generating a total score ranging from 0 to 96. a higher score indicating worst self perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological inflexibility</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The scale that will be used is the Psychological Inflexibility in Pain Scale. It is a 12-item scale designed to measure psychological inflexibility in pain patients.The items consisted of different statements that were considered to be related to chronic pain, psychological inflexibility, suffering and disability All of the items were rated on a 7-point Likert-type scale that ranged from &quot;1=never true&quot; to &quot;7=always true&quot;, with higher scores indicating more psychological inflexibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of painful points</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The sensitivity of the 18 trigger points originally defined in the diagnosis of Fibromyalgia will be studied by means of an FPX 25 algometer (Wagner Instruments, Greenwich, USA) that records the pain threshold experienced</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: perceived well-being</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>SF-12 Satisfacción with life scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>Epworth Sleepiness Scale: the instrument asks the researched subject, about the frequency (or probability) of falling asleep on a scale of increase that from 0 to 3, for eight different daily situations, that most people can be involved, in your daily life, although not necessarily every day.2 The score of the 8 situations is added to obtain a total number. A result between 0 and 9 is considered normal; while one between 10 and 24 indicates that the patient should be referred to a specialist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of depression</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Higher punctuations meaning, Higher scores indicate that the degree of depression is more severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of stress</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>To assess the state of stress the scale will be used the perceived srtress scale. This scale is a self-report instrument that evaluates the level of stress perceived during the last month, consists of 14 items with a response format of a scale of five points (0 = never, 1 = almost never, 2 = from time to time). when, 3 = often, 4 = very often). The total score of the PSS is obtained by inverting the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0 = 4, 1 = 3, 2 = 2, 3 = 1 and 4 = 0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of anxiety</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>To assess the state of stress the scale will be used the Hospital Anxiety and Depression Scale, it is a self-applied questionnaire with 14 items, on a Likert scale of 0-3. Higher score, greater anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evoked motor potential</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The evoked motor potential will be recorded in each subject through the Neuro-MEP-Micro EMG, with the Neuro-MEO.NETomega.3.7.3.7 software. and surface electrodes placed in the musculature of the first dorsal interosseous. In addition, after acquiring the resting motor threshold of each subject, we have obtained the motor power evoked at 120 and 140%, to calculate the ratio of the amplitude of the potential.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor threshold</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>The resting motor threshold is defined as the minimum signal strength that must be provided to have an evoked motor potential of at least 50 microvolts in 50% of the tests. In our study we used the software TMS_MTAT_2.0.1 to calculate by means of an algorithm which is the minimum intensity of each subject, in the first dorsal interosseous of the right hand. To obtain it, a stimulation of a simple puslo will be carried out using the neuro-MS / D magnetic stimulator. Placed in the motor cortex M1, at 45º orientation with respect to the midline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pain biomarkers.</measure>
    <time_frame>Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks</time_frame>
    <description>Beta-endorphin concentrations (pg/mL) will be measured by Human β-EP(Beta-Endorphin) ELISA Kit. The concentration ofHumanβ-EPin the samples is then determined by comparing the optical density (OD) of the samples to the standard curve</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Hyperbaric group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnetic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Baseline group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperbaric group</intervention_name>
    <description>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.</description>
    <arm_group_label>Hyperbaric group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic group</intervention_name>
    <description>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.</description>
    <arm_group_label>Magnetic group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical group</intervention_name>
    <description>A protocol of low-impact physical exercise will be performed twice a week for 8 weeks, with a total of 16 sessions.</description>
    <arm_group_label>Physical group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baseline group</intervention_name>
    <description>This group will be the control group that did not take any action, perform the activities of daily life</description>
    <arm_group_label>Physical group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Fibromyalgia according to the criteria of the American College of&#xD;
             Rheumatology of 1990.&#xD;
&#xD;
          -  Having taken pharmacological treatment for more than three months without clinical&#xD;
             improvement.&#xD;
&#xD;
          -  Have the capacity to sign the informed consent form in accordance.&#xD;
&#xD;
          -  Not having previously received treatment with a hyperbaric chamber or transcranial&#xD;
             magnetic stimulation.&#xD;
&#xD;
          -  Absence of other pathologies associated with the locomotor system at an advanced stage&#xD;
             that makes physical activity impossible (arthritis, osteoarthritis, uric acid).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation period.&#xD;
&#xD;
          -  Epilepsy, drugs that lower the convulsive threshold, history of intense headaches, e&#xD;
             endocranial and auditory elements, pathology related to the nervous system, either&#xD;
             central or peripheral, not associated with fibromyalgia, endocranial hypertension.&#xD;
&#xD;
          -  Hospital hypertension not controlled, heart and / or respiratory failure, cardiac&#xD;
             pacemaker, pneumothorax.&#xD;
&#xD;
          -  Claustrofobia and / or psychiatric pathologies; schizophrenia, bipolar disorder,&#xD;
             psychosis.&#xD;
&#xD;
          -  Patients with problems of alcohol addiction, psychoactive drugs or narcotics.&#xD;
&#xD;
          -  Patients presenting neoplasia.&#xD;
&#xD;
          -  Surgical interventions of less than 4 months.&#xD;
&#xD;
          -  Tympanic perforations.&#xD;
&#xD;
          -  Cardiac slides.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth Izquierdo Alventosa, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundación Fivan</name>
      <address>
        <city>Valencia</city>
        <zip>46005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transcranial magnetic stimulation</keyword>
  <keyword>hyperbaric chamber</keyword>
  <keyword>pain</keyword>
  <keyword>endorphins</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03801109
org study id: H1548771544856
nct id: NCT03801109
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Changes in pain intensity
time frame: Hyperbaric, Physical and Baseline groups: change from baseline in the intensity of pain at 8 weeks. Magnetic group: change from baseline in the intensity of pain at 3 weeks.
description: Analog visual scale
measure: Rating of pain
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. Interpretation : 0 minimum pain score and 78 maximum pain score. The higher the pain score the greater the pain.
measure: Pain catastrophizing
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: it will be measurde by pain catastrophizing scale. It is a Self-administered scale on a 5-point Likert scale ranging from 0 (never) to 4 (always), which are distributed in 3 subscales: rumination (refers to a state or feeling of constant worry and the inability to inhibit thoughts related to pain), despair (manifested when hope has been lost for achieving something, or because it disappears or because it gives off some physical and / or psychological aspect that is detrimental to health) and magnification (refers to the exaggeration of unpleasant situations of pain and expectations of negative consequences). Higher scores indicate higher levels of catastrophism.
measure: Acceptance of pain
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The Chronic Pain Acceptance Questionnaire (CPAQ) is a 20-item inventory designed to measure acceptance of pain. here are two principle factors measured by this questionnaire: activities engagement and pain willingness. All items are rated on a 0 (never true) to 6 (always true) scale. The maximum possible total score is 120, with a higher score indicating better acceptance
measure: Pain self perception
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The Pain Self-Perception Scale (PSPS) is a 24-item questionnaire used to assess mental defeat in chronic pain patients. espondents are asked to indicate to what extent each of the 24 statements applied to their experience "during a recent episode of intense pain". These statements are to be rated on a 5-point scale (0 = "Not at all/Never," 1 = "Very little," 2 = "Moderately," 3 = "Strongly," 4 = "Very strongly"), generating a total score ranging from 0 to 96. a higher score indicating worst self perception
measure: Psychological inflexibility
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The scale that will be used is the Psychological Inflexibility in Pain Scale. It is a 12-item scale designed to measure psychological inflexibility in pain patients.The items consisted of different statements that were considered to be related to chronic pain, psychological inflexibility, suffering and disability All of the items were rated on a 7-point Likert-type scale that ranged from "1=never true" to "7=always true", with higher scores indicating more psychological inflexibility.
measure: Number of painful points
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The sensitivity of the 18 trigger points originally defined in the diagnosis of Fibromyalgia will be studied by means of an FPX 25 algometer (Wagner Instruments, Greenwich, USA) that records the pain threshold experienced
measure: Quality of life: perceived well-being
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: SF-12 Satisfacción with life scale
measure: Quality of sleep
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: Epworth Sleepiness Scale: the instrument asks the researched subject, about the frequency (or probability) of falling asleep on a scale of increase that from 0 to 3, for eight different daily situations, that most people can be involved, in your daily life, although not necessarily every day.2 The score of the 8 situations is added to obtain a total number. A result between 0 and 9 is considered normal; while one between 10 and 24 indicates that the patient should be referred to a specialist.
measure: Level of depression
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Higher punctuations meaning, Higher scores indicate that the degree of depression is more severe
measure: Level of stress
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: To assess the state of stress the scale will be used the perceived srtress scale. This scale is a self-report instrument that evaluates the level of stress perceived during the last month, consists of 14 items with a response format of a scale of five points (0 = never, 1 = almost never, 2 = from time to time). when, 3 = often, 4 = very often). The total score of the PSS is obtained by inverting the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0 = 4, 1 = 3, 2 = 2, 3 = 1 and 4 = 0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.
measure: Level of anxiety
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: To assess the state of stress the scale will be used the Hospital Anxiety and Depression Scale, it is a self-applied questionnaire with 14 items, on a Likert scale of 0-3. Higher score, greater anxiety and depression.
measure: Evoked motor potential
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The evoked motor potential will be recorded in each subject through the Neuro-MEP-Micro EMG, with the Neuro-MEO.NETomega.3.7.3.7 software. and surface electrodes placed in the musculature of the first dorsal interosseous. In addition, after acquiring the resting motor threshold of each subject, we have obtained the motor power evoked at 120 and 140%, to calculate the ratio of the amplitude of the potential.
measure: Motor threshold
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: The resting motor threshold is defined as the minimum signal strength that must be provided to have an evoked motor potential of at least 50 microvolts in 50% of the tests. In our study we used the software TMS_MTAT_2.0.1 to calculate by means of an algorithm which is the minimum intensity of each subject, in the first dorsal interosseous of the right hand. To obtain it, a stimulation of a simple puslo will be carried out using the neuro-MS / D magnetic stimulator. Placed in the motor cortex M1, at 45º orientation with respect to the midline.
measure: Plasma pain biomarkers.
time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
description: Beta-endorphin concentrations (pg/mL) will be measured by Human β-EP(Beta-Endorphin) ELISA Kit. The concentration ofHumanβ-EPin the samples is then determined by comparing the optical density (OD) of the samples to the standard curve
arm group label: Hyperbaric group
arm group type: Experimental
arm group label: Magnetic group
arm group type: Experimental
arm group label: Physical group
arm group type: Active Comparator
arm group label: Baseline group
arm group type: No Intervention
intervention type: Other
intervention name: Hyperbaric group
description: 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.
arm group label: Hyperbaric group
intervention type: Other
intervention name: Magnetic group
description: 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.
arm group label: Magnetic group
intervention type: Other
intervention name: Physical group
description: A protocol of low-impact physical exercise will be performed twice a week for 8 weeks, with a total of 16 sessions.
arm group label: Physical group
intervention type: Other
intervention name: Baseline group
description: This group will be the control group that did not take any action, perform the activities of daily life
arm group label: Physical group
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ruth Izquierdo Alventosa, PT
role: Principal Investigator
affiliation: University of Valencia
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: Undecided