<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/NCT03044067</url>
  </required_header>
  <id_info>
    <org_study_id>UniversityMalaga</org_study_id>
    <nct_id>NCT03044067</nct_id>
  </id_info>
  <brief_title>Effects of Pain Neuroscience Education in Fibromyalgia</brief_title>
  <official_title>The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaga</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This&#xD;
      condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a&#xD;
      female to male ratio of 3:1) over 50 years of age with low education level and low&#xD;
      socioeconomic status, living in rural areas. High direct medical costs and significant&#xD;
      indirect costs of this condition can't be ignored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design and setting: The design of the present study will be a randomized controlled&#xD;
      trial with 2 follow-ups (one week and one month after intervention) that will be performed&#xD;
      between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be&#xD;
      assessed at baseline (t1), one week after intervention (t2), and one moth after intervention&#xD;
      (t3). Written informed consent will be acquired for all participants prior to their&#xD;
      participation. The study will be implemented and reported in line with the CONSORT statement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline function at 1 month</measure>
    <time_frame>1 month</time_frame>
    <description>This outcome will be measured with the pain disability index (PDI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline pain at 1 month</measure>
    <time_frame>1 month</time_frame>
    <description>This outcome will be measured with the numerical pain rating scale (NRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline self-efficacy at 1 moths</measure>
    <time_frame>1 month</time_frame>
    <description>Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will be measure the patient's confidence in performing certain activities despite pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Pain neuroscience education + Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. It will be applied three times (at baseline, one week and one month after intervention). Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain neuroscience education + Exercise</intervention_name>
    <description>A session of Pain neuroscience education + Exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. Besides that it will be covered the understanding and acknowledgement about how pain is processed.</description>
    <arm_group_label>Pain neuroscience education + Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-70 years.&#xD;
&#xD;
          -  Willing and able to participate&#xD;
&#xD;
          -  Diagnosis of Fibromyalgia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic diseases&#xD;
&#xD;
          -  Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid&#xD;
             arthritis, ankylosing spondylitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alejandro Luque Suarez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Javier Matias Soto, PT</last_name>
    <phone>616375349</phone>
    <phone_ext>+34</phone_ext>
    <email>msjavi93@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alejandro Luque Suarez, PhD</last_name>
    <email>aluques@uma.es</email>
  </overall_contact_backup>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaga</investigator_affiliation>
    <investigator_full_name>Alejandro Luque-Suarez</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Chronic pain</keyword>
  <keyword>Fibromyalgia</keyword>
  <keyword>Pain neuroscience education</keyword>
  <keyword>Exercise</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>No</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/NCT03044067
org study id: UniversityMalaga
nct id: NCT03044067
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This
      condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a
      female to male ratio of 3:1) over 50 years of age with low education level and low
      socioeconomic status, living in rural areas. High direct medical costs and significant
      indirect costs of this condition can't be ignored.
Study design and setting: The design of the present study will be a randomized controlled
      trial with 2 follow-ups (one week and one month after intervention) that will be performed
      between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be
      assessed at baseline (t1), one week after intervention (t2), and one moth after intervention
      (t3). Written informed consent will be acquired for all participants prior to their
      participation. The study will be implemented and reported in line with the CONSORT statement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline function at 1 month
time frame: 1 month
description: This outcome will be measured with the pain disability index (PDI)
measure: Change from Baseline pain at 1 month
time frame: 1 month
description: This outcome will be measured with the numerical pain rating scale (NRS)
measure: Change from Baseline self-efficacy at 1 moths
time frame: 1 month
description: Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will be measure the patient's confidence in performing certain activities despite pain.
arm group label: Pain neuroscience education + Exercise
arm group type: Experimental
description: Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. It will be applied three times (at baseline, one week and one month after intervention). Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities.
arm group label: Exercise
arm group type: Active Comparator
description: Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment.
intervention type: Other
intervention name: Pain neuroscience education + Exercise
description: A session of Pain neuroscience education + Exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. Besides that it will be covered the understanding and acknowledgement about how pain is processed.
arm group label: Pain neuroscience education + Exercise
intervention type: Other
intervention name: Exercise
description: A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.
arm group label: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alejandro Luque Suarez, PhD
role: Principal Investigator
affiliation: University of Malaga
last name: Javier Matias Soto, PT
phone: 616375349
phone ext: +34
email: msjavi93@gmail.com
last name: Alejandro Luque Suarez, PhD
email: aluques@uma.es
responsible party type: Principal Investigator
investigator affiliation: University of Malaga
investigator full name: Alejandro Luque-Suarez
investigator title: PhD
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No