xml: <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/NCT05967052</url>
    </required_header>
    <id_info>
      <org_study_id>NIGRIR_001POSTCOVID</org_study_id>
      <nct_id>NCT05967052</nct_id>
    </id_info>
    <brief_title>Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation</brief_title>
    <acronym>POSTCOVID</acronym>
    <official_title>Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical Research Agency, Poland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland</source>
    <oversight_info>
      <has_dmc>No</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>
        This is a single-center, prospective, randomized, double-blind (pharmacotherapy),&#xD;
        placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the&#xD;
        usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome).&#xD;
  &#xD;
        Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided&#xD;
        doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with&#xD;
        pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months&#xD;
        (177-187 days).&#xD;
  &#xD;
        There will be 4 outpatient visits to the research center and 12 telephone consultations.&#xD;
  &#xD;
        The procedures and assessments performed as part of the study are listed in the study&#xD;
        schedule.&#xD;
  &#xD;
        It is planned to include 132 patients in the study, which, assuming a 10% level of&#xD;
        non-completion of the program, will result in the examination of 120 patients (30 in each&#xD;
        arm).&#xD;
  &#xD;
        Patients will be recruited during an outpatient medical consultation with a general&#xD;
        practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with&#xD;
        the use of information materials in the form of leaflets and advertisements on the Internet.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2028</primary_completion_date>
    <phase>Phase 2</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Walking distance as a difference in score from the 6 Minute Walking Test</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the result obtained in the &quot;Beck Depression Inventory (BDIII)&quot; study</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the result obtained in the &quot;Beck Depression Inventory (BDIII)&quot; study in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of starting the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the result of the CCT test</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the result of the CCT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day of the study commencement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the result of the RFFT test</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the result of the RFFT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the WAIS-R intelligence test result</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the WAIS-R intelligence test result in the 3rd and 6th month of the study in relation to the result on the day of the study commencement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in reaction time expressed by the Stroop interference test</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in reaction time expressed by the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day of the study start.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the assessment of the quality of gait</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in the assessment of the quality of gait in the 3rd and 6th month of the study in relation to the result on the day of the beginning of the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in walking speed</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Change in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The change in the profile of the examined inflammatory cytokines</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>The exploratory endpoint is the change in the profile of the examined inflammatory cytokines in the 3rd and 6th month of the study in relation to the result before the start of the study.</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of adverse events and the number and percentage of patients who experienced adverse events</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Number of adverse events and the number and percentage of patient who experienced adverse events</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of serious adverse events and number and proportion of patients with serious adverse events.</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Number of serious adverse events and number and proportion of patients with serious adverse events.</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.</description>
    </other_outcome>
    <other_outcome>
      <measure>Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.</measure>
      <time_frame>3 months and 6 months</time_frame>
      <description>Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">132</enrollment>
    <condition>Chronic Fatigue Syndrome</condition>
    <condition>COVID-19, Long Haul</condition>
    <arm_group>
      <arm_group_label>Pregabalin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Pregabalin + Rehabilitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Rehabilitation + Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pregabalin</intervention_name>
      <description>Pregabalin pharmacotherapy</description>
      <arm_group_label>Pregabalin</arm_group_label>
      <arm_group_label>Pregabalin + Rehabilitation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Independent walking training</intervention_name>
      <description>Independent walking training</description>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_label>Pregabalin</arm_group_label>
      <arm_group_label>Pregabalin + Rehabilitation</arm_group_label>
      <arm_group_label>Rehabilitation + Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_label>Rehabilitation + Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Gradual movement therapy in the ward</intervention_name>
      <description>Gradual movement therapy in the ward</description>
      <arm_group_label>Pregabalin + Rehabilitation</arm_group_label>
      <arm_group_label>Rehabilitation + Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Telerehabilitation</intervention_name>
      <description>Telerehabilitation</description>
      <arm_group_label>Pregabalin + Rehabilitation</arm_group_label>
      <arm_group_label>Rehabilitation + Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychotherapy</intervention_name>
      <description>Psychotherapy</description>
      <arm_group_label>Pregabalin + Rehabilitation</arm_group_label>
      <arm_group_label>Rehabilitation + Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The patient correctly gave written informed consent to participate in the study;&#xD;
  &#xD;
            2. Men or women between the ages of 18 and 65 inclusive at the time of signing the&#xD;
               informed consent;&#xD;
  &#xD;
            3. Patient after a minimum of 6 months from the documented detection of SARS-CoV-2&#xD;
               infection (document confirming the history of the disease, including a positive result&#xD;
               of the PCR or antigen test, certificate of convalescence; medical documentation&#xD;
               confirming the infection; the condition is also considered fulfilled in the case of&#xD;
               documented infection asymptomatic);&#xD;
  &#xD;
            4. During the screening, the patient meets the criteria for the diagnosis of chronic&#xD;
               fatigue syndrome (CFS) according to the National Academy of Medicine (2015);&#xD;
  &#xD;
            5. Women:&#xD;
  &#xD;
               a) incapable of having children (post-menopausal or child-bearing, subjected to&#xD;
               permanent sterilization); (b) of childbearing potential with a negative pregnancy test&#xD;
               result at screening and using a highly effective method of contraception throughout&#xD;
               the IMP use and for 7 days after the last IMP use.&#xD;
  &#xD;
            6. The patient agrees to participate in all activities provided for in the study.&#xD;
  &#xD;
            7. The patient is able to understand the information presented and give informed consent&#xD;
               to participate in the study prior to screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Vital functions disorders;&#xD;
  &#xD;
            2. Documented hypersensitivity to pregabalin or any of the excipients of the formulation&#xD;
               (i.e., lactose);&#xD;
  &#xD;
            3. Moderate or severe depression during treatment or present during psychiatric&#xD;
               evaluation at baseline;&#xD;
  &#xD;
            4. Concurrent treatment with opioids or other antiepileptic drugs (including tramadol,&#xD;
               buprenorphine, morphine, oxycodone, gabapentin, duloxetine);&#xD;
  &#xD;
            5. Pregnant or breastfeeding women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Beata Tarnacka, Prof, Md, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Institute of Geriatrics, Rheumatology and Rehabilitation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Beata Tarnacka, Prof, Md, PhD</last_name>
      <phone>22 6709176</phone>
      <phone_ext>+48</phone_ext>
      <email>klinika.rehabilitacji@spartanska.pl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centrum Wsparcia Badań Klinicznych</name>
        <address>
          <city>Warsaw</city>
          <state>Mazowieckie</state>
          <zip>02-637</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Agnieszka Kurowska</last_name>
        <phone>691 326 114</phone>
        <phone_ext>+48</phone_ext>
        <email>agnieszka.kurowska@spartanska.pl</email>
      </contact>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>chronic fatigue syndrome</keyword>
    <keyword>associated with post-COVID syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pregabalin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967052
  org study id: NIGRIR_001POSTCOVID
  nct id: NCT05967052
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, prospective, randomized, double-blind (pharmacotherapy),
        placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the
        usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome).
  
        Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided
        doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with
        pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months
        (177-187 days).
  
        There will be 4 outpatient visits to the research center and 12 telephone consultations.
  
        The procedures and assessments performed as part of the study are listed in the study
        schedule.
  
        It is planned to include 132 patients in the study, which, assuming a 10% level of
        non-completion of the program, will result in the examination of 120 patients (30 in each
        arm).
  
        Patients will be recruited during an outpatient medical consultation with a general
        practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with
        the use of information materials in the form of leaflets and advertisements on the Internet.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score
  time frame: 3 months and 6 months
  description: Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score
  measure: Walking distance as a difference in score from the 6 Minute Walking Test
  time frame: 3 months and 6 months
  description: Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline
  measure: Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)
  time frame: 3 months and 6 months
  description: Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of the study
  measure: Change in the result obtained in the "Beck Depression Inventory (BDIII)" study
  time frame: 3 months and 6 months
  description: Change in the result obtained in the "Beck Depression Inventory (BDIII)" study in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.
  measure: Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)
  time frame: 3 months and 6 months
  description: Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.
  measure: Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i
  time frame: 3 months and 6 months
  description: Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of starting the study
  measure: Change in the result of the CCT test
  time frame: 3 months and 6 months
  description: Change in the result of the CCT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.
  measure: Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)
  time frame: 3 months and 6 months
  description: Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day of the study commencement.
  measure: Change in the result of the RFFT test
  time frame: 3 months and 6 months
  description: Change in the result of the RFFT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.
  measure: Change in the WAIS-R intelligence test result
  time frame: 3 months and 6 months
  description: Change in the WAIS-R intelligence test result in the 3rd and 6th month of the study in relation to the result on the day of the study commencement
  measure: Change in reaction time expressed by the Stroop interference test
  time frame: 3 months and 6 months
  description: Change in reaction time expressed by the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day of the study start.
  measure: Change in the assessment of the quality of gait
  time frame: 3 months and 6 months
  description: Change in the assessment of the quality of gait in the 3rd and 6th month of the study in relation to the result on the day of the beginning of the study
  measure: Change in walking speed
  time frame: 3 months and 6 months
  description: Change in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.
  measure: The change in the profile of the examined inflammatory cytokines
  time frame: 3 months and 6 months
  description: The exploratory endpoint is the change in the profile of the examined inflammatory cytokines in the 3rd and 6th month of the study in relation to the result before the start of the study.
  measure: Number of adverse events and the number and percentage of patients who experienced adverse events
  time frame: 3 months and 6 months
  description: Number of adverse events and the number and percentage of patient who experienced adverse events
  measure: Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events
  time frame: 3 months and 6 months
  description: Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events
  measure: Number of serious adverse events and number and proportion of patients with serious adverse events.
  time frame: 3 months and 6 months
  description: Number of serious adverse events and number and proportion of patients with serious adverse events.
  measure: Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
  time frame: 3 months and 6 months
  description: Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
  measure: Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.
  time frame: 3 months and 6 months
  description: Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.
  arm group label: Pregabalin
  arm group type: Experimental
  arm group label: Pregabalin + Rehabilitation
  arm group type: Experimental
  arm group label: Rehabilitation + Placebo
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Pregabalin
  description: Pregabalin pharmacotherapy
  arm group label: Pregabalin
  arm group label: Pregabalin + Rehabilitation
  intervention type: Behavioral
  intervention name: Independent walking training
  description: Independent walking training
  arm group label: Placebo
  arm group label: Pregabalin
  arm group label: Pregabalin + Rehabilitation
  arm group label: Rehabilitation + Placebo
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  arm group label: Rehabilitation + Placebo
  intervention type: Behavioral
  intervention name: Gradual movement therapy in the ward
  description: Gradual movement therapy in the ward
  arm group label: Pregabalin + Rehabilitation
  arm group label: Rehabilitation + Placebo
  intervention type: Behavioral
  intervention name: Telerehabilitation
  description: Telerehabilitation
  arm group label: Pregabalin + Rehabilitation
  arm group label: Rehabilitation + Placebo
  intervention type: Behavioral
  intervention name: Psychotherapy
  description: Psychotherapy
  arm group label: Pregabalin + Rehabilitation
  arm group label: Rehabilitation + Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Beata Tarnacka, Prof, Md, PhD
  role: Principal Investigator
  affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
  last name: Beata Tarnacka, Prof, Md, PhD
  phone: 22 6709176
  phone ext: +48
  email: klinika.rehabilitacji@spartanska.pl
  facility: 
  status: Recruiting
  contact: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Fatigue Syndrome, Chronic
  mesh term: Syndrome
  mesh term: Fatigue
  mesh term: Pregabalin