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/NCT05974072</url>
    </required_header>
    <id_info>
      <org_study_id>PAINDOC</org_study_id>
      <nct_id>NCT05974072</nct_id>
    </id_info>
    <brief_title>A Feasibility Study of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain: PAINDOC Study.</brief_title>
    <official_title>A Feasibility Study of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain: PAINDOC Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Barcelona</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Barcelona</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>
        The present feasibility study aims to evaluate the feasibility and adequacy of a&#xD;
        multidisciplinary treatment program as a therapeutic option for patients with chronic low&#xD;
        back pain referred to the pain unit of the Hospital Clinic of Barcelona. Secondarily, the&#xD;
        present study will also evaluate the effect on pain-related outcomes to estimate the number&#xD;
        of needed participants for a full trial.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is the proposed multidisciplinary treatment feasible and adequate for chronic low back&#xD;
             pain patients?&#xD;
  &#xD;
          -  Is the proposed multidisciplinary treatment effective in improving pain-related&#xD;
             outcomes?&#xD;
  &#xD;
        Participants will receive either usual care (pharmacological control) or eight&#xD;
        multidisciplinary sessions within two months, composed of therapeutic patient education,&#xD;
        mindfulness relaxation, cognitive-behavioural therapy and therapeutic exercise. Besides,&#xD;
        participants will be assessed using written questionnaires before and after treatment and two&#xD;
        months after treatment.&#xD;
  &#xD;
        Researchers will assess the feasibility of the multidisciplinary treatment group and will&#xD;
        compare both groups to see if there is any difference in several pain-related outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Despite improving pharmacological and surgical medical treatment options, long-lasting low&#xD;
        back pain is the most frequent pain disorder and a leading cause of disability. Over the past&#xD;
        decades, clinicians have acknowledged that a broader view of disease and disability is needed&#xD;
        in chronic conditions treatment. Therefore, biological, psychological and social factors must&#xD;
        be addressed to improve such conditions.&#xD;
  &#xD;
        The present study aims to evaluate the viability and adequacy of a multidisciplinary&#xD;
        treatment program (PAINDOC Program) as a therapeutic option for patients with chronic low&#xD;
        back pain referred to the pain unit of the Hospital Clínic of Barcelona. The secondary&#xD;
        objectives are to evaluate the effect of the PAINDOC Program on the reduction of pain&#xD;
        intensity, the improvement of pain-related disability, the improvement of quality of life,&#xD;
        and the reduction of pain catastrophizing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 24, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</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>
      <masking_description>Two armed, parallel groups, single blind, unicentric, randomized feasibility study</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>4 months prior to study start</time_frame>
      <description>To obtain this information, the number of participants included in the program for four consecutive months will be calculated. The number of eligible participants, the number of participants included and excluded, and the reasons for exclusion will be detailed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants completing treatment</measure>
      <time_frame>2 months</time_frame>
      <description>Acceptable compliance has been defined as at least 80% of participants included in the program completing all program sessions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Follow-up rate</measure>
      <time_frame>4 months</time_frame>
      <description>to determine the follow-up rate, the number of participants who complete the evaluations at each evaluation point in the study will be detailed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptance of treatment and detection of barriers</measure>
      <time_frame>2 months</time_frame>
      <description>Treatment acceptance will be assessed through a qualitative approach, based on focus groups and content analysis. The study will have a phenomenological approach to understand and know directly the experiences of the participants. The research will be conducted from the interpretive paradigm, as it seeks to understand and interpret the deep meaning of the observed phenomena. In addition, it is based on an inductive methodology that starts from reality to generate theories, so the fieldwork does not start from a hypothesis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain Intensity. Changes from baseline to 2 months after treatment.</measure>
      <time_frame>Baseline, 2 months, 4 months</time_frame>
      <description>Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = worst imaginable pain. The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in low back pain patients. For patients with subacute or chronic low back pain, the minimum clinically relevant change is considered to be at least 20 mm on a VAS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain-related disability. Changes from baseline to 2 months after treatment.</measure>
      <time_frame>Baseline, 2 months, 4 months</time_frame>
      <description>Disability will be assessed using the spanish version of the Oswestry Disability Index (ODI) questionnaire. The ODI is one of the most common specific measurement tools to evaluate the function and disability of lumbar spine pathologies. This questionnaire contains 10 items evaluated from 0 to 5 (higher values indicate greater disability), which correspond to 10 domains. The sum of the 10 scores is expressed as a percentage (ODI score), with ranges from 0% (no disability) to 100% (maximum disability).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life. Changes from baseline to 2 months after treatment.</measure>
      <time_frame>Baseline, 2 months, 4 months</time_frame>
      <description>The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead &lt;0 to full health 1).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Catastrophizing. Changes from baseline to 2 months after treatment.</measure>
      <time_frame>Baseline, 2 months, 4 months</time_frame>
      <description>The Spanish version of Pain Catastrophizing Scale (PCS) was used to asses thoughts and feelings related to pain experiences.(9) The PCS is a 13 item self-administered questionnaire composed of 3 subscales: rumination, magnification and helplessness. The PCS uses a 5-point Likert scale with responses ranging from 0 = not at all to 4 = all the time. Overall scores range from 0 to 52 points, the higher the score, the higher is the pain catastrophism level.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Chronic Low-back Pain</condition>
    <arm_group>
      <arm_group_label>Usual Care (Pharmacological Control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The subjects in the control group will be treated following a pharmacological approach according to the latest clinical guidelines for patients with chronic low back pain. Thus, the pharmacological options to be considered in each patient will be those included in the first and second analgesic steps of the WHO (preferably without including minor opioids).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PAINDOC Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 8 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over two months.&#xD;
  It consists of a therapeutic education (Empowered Relief) session given by a physician from the unit, a pain psychology session given by a psychologist, an introductory mindfulness meditation session given by an advanced practice nurse, and two pain neuroscience education sessions and three therapeutic exercise sessions given by a physiotherapist. This program is already part of the pain unit's routine care practice, so it is considered that the sessions of this program do not represent an additional and specific visit for the patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.</description>
      <arm_group_label>Usual Care (Pharmacological Control)</arm_group_label>
      <other_name>Pharmacological Control</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PAINDOC Program</intervention_name>
      <description>The PAINDOC Program consists in:&#xD;
  Therapeutic education: The therapeutic education block consists of two parts: an education session called Empowered Relief (ER) and two pain neuroscience education (NDT) sessions.&#xD;
  Psychotherapy: The psychotherapy part consists of one group session of one hour, face-to-face and with groups of up to 15 people, given by the psychologist of the pain unit.&#xD;
  Mindfulness Meditation: The Mindfulness Meditation consists of one group session of one hour, face-to-face and with groups of up to 15 people. These are given by a nurse from the pain unit. T&#xD;
  Therapeutic exercise: The therapeutic exercise module consists of three sessions of one hour each, face-to-face, with small groups of between 6 and 10 patients, and given by the physiotherapist of the pain unit.</description>
      <arm_group_label>PAINDOC Program</arm_group_label>
      <other_name>Multidisciplinary and multimodal intervention</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with primary chronic low back pain (non-specific chronic low back pain).&#xD;
  &#xD;
            -  Predominantly axial pain, for at least 50% of the time during the last 6 months.&#xD;
  &#xD;
            -  Average pain intensity equal or greater than 4 out of 10 on a verbal numerical scale,&#xD;
               during the present week.&#xD;
  &#xD;
            -  Predisposed to receive an active, non-pharmacological and non-surgical treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inflammatory low back pain.&#xD;
  &#xD;
            -  History of cancer in the past 5 years.&#xD;
  &#xD;
            -  Unexplained and involuntary weight loss of 10 Kg during the last year.&#xD;
  &#xD;
            -  Problems in the control of bowel and bladder function.&#xD;
  &#xD;
            -  Difficulty attending sessions due to severe physical disability.&#xD;
  &#xD;
            -  Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder,&#xD;
               etc.).&#xD;
  &#xD;
            -  Addiction disorder to parenteral drugs or strong prescription opioids.&#xD;
               Technical-logistical problems (inability to attend treatment sessions, inability to&#xD;
               complete evaluation questionnaires).&#xD;
  &#xD;
            -  Seeking compensation or litigation in the last year.&#xD;
  &#xD;
            -  Severe hearing loss or severe cognitive impairment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Marc Terradas-Monllor, PhD</last_name>
      <phone>+34 652948632</phone>
      <email>marc.terradas@uvic.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anna Dalmau-Roig, MD</last_name>
      <phone>+34 639482849</phone>
      <email>dalmaur@clinic.cat</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Clinic de Barcelona</name>
        <address>
          <city>Barcelona</city>
          <state>Catalonia</state>
          <zip>08006</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anna Dalmau-Roig, MD</last_name>
        <phone>+34639482849</phone>
        <email>dalmaur@clinic.cat</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.</citation>
      <PMID>27002445</PMID>
    </reference>
    <reference>
      <citation>Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7.</citation>
      <PMID>34062143</PMID>
    </reference>
    <reference>
      <citation>Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739.</citation>
      <PMID>34398206</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Vic - Central University of Catalonia</investigator_affiliation>
      <investigator_full_name>Marc Terradas Monllor</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>chronic pain</keyword>
    <keyword>pain catastrophizing</keyword>
    <keyword>therapeutic patient education</keyword>
    <keyword>therapeutic exercise</keyword>
    <keyword>mindfulness</keyword>
    <keyword>cognitive behavioural therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05974072
  org study id: PAINDOC
  nct id: NCT05974072
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present feasibility study aims to evaluate the feasibility and adequacy of a
        multidisciplinary treatment program as a therapeutic option for patients with chronic low
        back pain referred to the pain unit of the Hospital Clinic of Barcelona. Secondarily, the
        present study will also evaluate the effect on pain-related outcomes to estimate the number
        of needed participants for a full trial.
  
        The main questions it aims to answer are:
  
          -  Is the proposed multidisciplinary treatment feasible and adequate for chronic low back
             pain patients?
  
          -  Is the proposed multidisciplinary treatment effective in improving pain-related
             outcomes?
  
        Participants will receive either usual care (pharmacological control) or eight
        multidisciplinary sessions within two months, composed of therapeutic patient education,
        mindfulness relaxation, cognitive-behavioural therapy and therapeutic exercise. Besides,
        participants will be assessed using written questionnaires before and after treatment and two
        months after treatment.
  
        Researchers will assess the feasibility of the multidisciplinary treatment group and will
        compare both groups to see if there is any difference in several pain-related outcomes.
  Despite improving pharmacological and surgical medical treatment options, long-lasting low
        back pain is the most frequent pain disorder and a leading cause of disability. Over the past
        decades, clinicians have acknowledged that a broader view of disease and disability is needed
        in chronic conditions treatment. Therefore, biological, psychological and social factors must
        be addressed to improve such conditions.
  
        The present study aims to evaluate the viability and adequacy of a multidisciplinary
        treatment program (PAINDOC Program) as a therapeutic option for patients with chronic low
        back pain referred to the pain unit of the Hospital Clínic of Barcelona. The secondary
        objectives are to evaluate the effect of the PAINDOC Program on the reduction of pain
        intensity, the improvement of pain-related disability, the improvement of quality of life,
        and the reduction of pain catastrophizing.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Two armed, parallel groups, single blind, unicentric, randomized feasibility study
  measure: Recruitment rate
  time frame: 4 months prior to study start
  description: To obtain this information, the number of participants included in the program for four consecutive months will be calculated. The number of eligible participants, the number of participants included and excluded, and the reasons for exclusion will be detailed.
  measure: Number of participants completing treatment
  time frame: 2 months
  description: Acceptable compliance has been defined as at least 80% of participants included in the program completing all program sessions.
  measure: Follow-up rate
  time frame: 4 months
  description: to determine the follow-up rate, the number of participants who complete the evaluations at each evaluation point in the study will be detailed.
  measure: Acceptance of treatment and detection of barriers
  time frame: 2 months
  description: Treatment acceptance will be assessed through a qualitative approach, based on focus groups and content analysis. The study will have a phenomenological approach to understand and know directly the experiences of the participants. The research will be conducted from the interpretive paradigm, as it seeks to understand and interpret the deep meaning of the observed phenomena. In addition, it is based on an inductive methodology that starts from reality to generate theories, so the fieldwork does not start from a hypothesis.
  measure: Pain Intensity. Changes from baseline to 2 months after treatment.
  time frame: Baseline, 2 months, 4 months
  description: Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = worst imaginable pain. The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in low back pain patients. For patients with subacute or chronic low back pain, the minimum clinically relevant change is considered to be at least 20 mm on a VAS.
  measure: Pain-related disability. Changes from baseline to 2 months after treatment.
  time frame: Baseline, 2 months, 4 months
  description: Disability will be assessed using the spanish version of the Oswestry Disability Index (ODI) questionnaire. The ODI is one of the most common specific measurement tools to evaluate the function and disability of lumbar spine pathologies. This questionnaire contains 10 items evaluated from 0 to 5 (higher values indicate greater disability), which correspond to 10 domains. The sum of the 10 scores is expressed as a percentage (ODI score), with ranges from 0% (no disability) to 100% (maximum disability).
  measure: Health-related quality of life. Changes from baseline to 2 months after treatment.
  time frame: Baseline, 2 months, 4 months
  description: The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead <0 to full health 1).
  measure: Pain Catastrophizing. Changes from baseline to 2 months after treatment.
  time frame: Baseline, 2 months, 4 months
  description: The Spanish version of Pain Catastrophizing Scale (PCS) was used to asses thoughts and feelings related to pain experiences.(9) The PCS is a 13 item self-administered questionnaire composed of 3 subscales: rumination, magnification and helplessness. The PCS uses a 5-point Likert scale with responses ranging from 0 = not at all to 4 = all the time. Overall scores range from 0 to 52 points, the higher the score, the higher is the pain catastrophism level.
  arm group label: Usual Care (Pharmacological Control)
  arm group type: Active Comparator
  description: The subjects in the control group will be treated following a pharmacological approach according to the latest clinical guidelines for patients with chronic low back pain. Thus, the pharmacological options to be considered in each patient will be those included in the first and second analgesic steps of the WHO (preferably without including minor opioids).
  arm group label: PAINDOC Program
  arm group type: Experimental
  description: The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 8 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over two months.
  It consists of a therapeutic education (Empowered Relief) session given by a physician from the unit, a pain psychology session given by a psychologist, an introductory mindfulness meditation session given by an advanced practice nurse, and two pain neuroscience education sessions and three therapeutic exercise sessions given by a physiotherapist. This program is already part of the pain unit's routine care practice, so it is considered that the sessions of this program do not represent an additional and specific visit for the patients.
  intervention type: Drug
  intervention name: Usual Care
  description: The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.
  arm group label: Usual Care (Pharmacological Control)
  other name: Pharmacological Control
  intervention type: Other
  intervention name: PAINDOC Program
  description: The PAINDOC Program consists in:
  Therapeutic education: The therapeutic education block consists of two parts: an education session called Empowered Relief (ER) and two pain neuroscience education (NDT) sessions.
  Psychotherapy: The psychotherapy part consists of one group session of one hour, face-to-face and with groups of up to 15 people, given by the psychologist of the pain unit.
  Mindfulness Meditation: The Mindfulness Meditation consists of one group session of one hour, face-to-face and with groups of up to 15 people. These are given by a nurse from the pain unit. T
  Therapeutic exercise: The therapeutic exercise module consists of three sessions of one hour each, face-to-face, with small groups of between 6 and 10 patients, and given by the physiotherapist of the pain unit.
  arm group label: PAINDOC Program
  other name: Multidisciplinary and multimodal intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marc Terradas-Monllor, PhD
  phone: +34 652948632
  email: marc.terradas@uvic.cat
  last name: Anna Dalmau-Roig, MD
  phone: +34 639482849
  email: dalmaur@clinic.cat
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  citation: Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
  PMID: 27002445
  citation: Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7.
  PMID: 34062143
  citation: Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739.
  PMID: 34398206
  responsible party type: Principal Investigator
  investigator affiliation: University of Vic - Central University of Catalonia
  investigator full name: Marc Terradas Monllor
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No