<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/NCT03036553</url>
  </required_header>
  <id_info>
    <org_study_id>UNMalaga</org_study_id>
    <nct_id>NCT03036553</nct_id>
  </id_info>
  <brief_title>Influence of Beliefs on the Prognosis of Chronic Musculoskeletal Pain.</brief_title>
  <official_title>The Influence of Beliefs (Fear of Movement, Pain-related Fear, Self-efficacy, and Pain Acceptance) on the Prognosis of Chronic Musculoskeletal Pain: a Prospective Cohort Study. Study Protocol</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>
      Chronic musculoskeletal pain (CMP) is highly prevalent, disabling, and with high&#xD;
      socio-economic costs, with many negative effects on quality of life. CMP affects the ability&#xD;
      to perform work, social, recreational and domestic tasks, changing the mood and concentration&#xD;
      of this population. Despite the worldwide prevalence and socioeconomic burden of CMP, a clear&#xD;
      understanding of its etiology and pathogenesis remains elusive.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      (i) to analyze the possible level of association between pain-related fear, fear of movement,&#xD;
      self-efficacy, and pain acceptance with pain intensity and disability at the start of the&#xD;
      study and prospectively evaluate its predictive function; (ii) to evaluate the possible&#xD;
      mediating role of fear of movement and self-efficacy in the relationship between&#xD;
      pain-disability in patients with CMP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study will be a prospective multi-centric 12-month study that will be conducted&#xD;
      in four primary care centers and a hospital in the province of Malaga. Several questionnaires&#xD;
      assessing different psychological factors will be administered to these participants. The&#xD;
      results will be evaluated at baseline (t1) and at 3 follow-up (after 3 (t2), 6 (t3) and 12&#xD;
      months (t4)). Ethical approval will be obtained from the Costal del Sol Ethics Committee,&#xD;
      Malaga, Spain. This study will follow the recommendations of the Declaration of Helsinki. The&#xD;
      study will be implemented and reported in line with the SPIRIT statement.&#xD;
&#xD;
      Participants A consecutive sample of CMP participants will be recruited. The general&#xD;
      practitioners will carry out the recruitment. Next, the physiotherapists attending the&#xD;
      research project, which will be previously instructed by the research team, will evaluate the&#xD;
      participants for their eligibility. If participants meet the eligibility criteria, they will&#xD;
      be invited to participate in this study, and then evaluated at baseline and 3, 6, and 12&#xD;
      months of follow-up. The inclusion criteria are: (i) men / women over the age of 18; (ii)&#xD;
      participants with musculoskeletal pain (pain intensity of 3 or more on a numerical scale of&#xD;
      pain 0-10) will be included in this study, among all of the following conditions: pain around&#xD;
      the axial skeleton (neck, lower back and / or pelvis) or peripheral joints (shoulder, elbow,&#xD;
      wrist, knee and / or ankle). We included people with clinical diagnoses of chronic pain&#xD;
      (shoulder pain, neck pain, whiplash disorder, temporomandibular joint disorders, pelvic pain&#xD;
      syndrome, ankle pain and epicondylalgia), non-specific low back pain, fibromyalgia, chronic&#xD;
      fatigue syndrome and those with a radiological diagnosis of osteoarthritis. (iii) duration of&#xD;
      symptoms: more than 3 months. Exclusion criteria are as follows: (i) musculoskeletal pain due&#xD;
      to traumatic or systemic inflammatory autoimmune diseases such as rheumatoid arthritis,&#xD;
      ankylosing spondylitis, spondylolisthesis or other defined rheumatological conditions; (ii)&#xD;
      musculoskeletal pain associated with neurological dysfunction (ie, multiple sclerosis or&#xD;
      stroke), osteoporosis, hemophilia and / or cancer; (iii) participants with post-fracture&#xD;
      musculoskeletal pain; (iv) inability to provide informed consent and / or complete written&#xD;
      questionnaires.&#xD;
&#xD;
      Recruitment The age and sex of those participants who refuse to participate in the project&#xD;
      will be noted anonymously, with the objective of evaluating the external validity of the&#xD;
      sample recruited from participants.&#xD;
&#xD;
      Eligible participants who are interested in the study will be asked to provide written&#xD;
      informed consent to participate. Participants will complete several questionnaires at&#xD;
      baseline, 3, 6, and 12 months after study initiation.&#xD;
&#xD;
      Participant data files will be stored in numerical order and in a safe and accessible place.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline the numerical pain rating scale (NRS) at 3,6,12 months</measure>
    <time_frame>Pain will be evaluated at baseline and 3 follow-ups (3,6,12 months).</time_frame>
    <description>Pain: The Numerical Rating Scale (NRS) will assess the pain intensity of each patient at baseline and prospectively. NRS scores range from 0 to 10, with 0 without pain and 10 with the worst pain imaginable. It has been shown that the NRS has a good test-retest reliability of the same day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline the pain disability index (PDI) at 3,6,12 months</measure>
    <time_frame>Disability will be evaluated at baseline and 3 follow-ups (3,6,12 months).</time_frame>
    <description>Disability: The Pain Disability Index (PDI) is a 7-question questionnaire that investigates the magnitude of disability due to pain in different situations such as work, leisure time, activities of daily living, and sports</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline the tampa scale for kinsiophobia (TSK-11) at 3,6,12 months</measure>
    <time_frame>Fear of movement will be evaluated at baseline and 3 follow-ups (3,6,12 months).</time_frame>
    <description>Fear of movement: The short version of the Tampa Scale for Kinesiophobia (TSK-11) will be used to assess fear of movement</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline the fear pain questionnaire (FPQ-III) at 3,6,12 months</measure>
    <time_frame>Pain-related fear will be evaluated at baseline and 3 follow-ups (3,6,12 months).</time_frame>
    <description>Pain-related fear: The short version (9-items) of the Fear of Pain Questionnaire (FPQ-III) will be used to assess the fear of pain in this population</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 3,6,12 months</measure>
    <time_frame>Pain acceptance will be evaluated at baseline and 3 follow-ups (3,6,12 months).</time_frame>
    <description>Pain acceptance: The Chronic Pain Acceptance Questionnaire (CPAQ) will measure pain acceptance through 20 items</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline the pain self-efficacy questionnaire (PSEQ) at 3,6,12 months</measure>
    <time_frame>Self-efficacy will be evaluated at baseline and 3 follow-ups (3,6,12 months).</time_frame>
    <description>Self-efficacy: The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">307</enrollment>
  <condition>Chronic Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>Chronic musculoskeletal pain</arm_group_label>
    <description>(i) men / women over the age of 18 (ii) participants with musculoskeletal pain (pain intensity of 3 or more on a numerical scale of pain 0-10) will be included in this study, among all of the following conditions: pain around the axial skeleton (neck, lower back And / or pelvis) or peripheral joints (shoulder, elbow, wrist, knee and / or ankle). We included people with clinical diagnoses of chronic pain (shoulder pain, neck pain, whiplash disorder, temporomandibular joint disorders, pelvic pain syndrome, ankle pain and epicondylalgia), non-specific low back pain, fibromyalgia, chronic fatigue syndrome and those with a radiological diagnosis of osteoarthritis.&#xD;
(iii) duration of symptoms: more than 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnosis/Prognosis</intervention_name>
    <description>The present study will be a prospective multi-centric 12-month study that will be conducted between May 2017 and April 2019 in four primary care centers and a hospital in the province of Malaga. Several questionnaires assessing different psychological factors will be administered to these participants. The results will be evaluated at baseline (t1) and at 3-fold follow-up (after 3 (t2), 6 (t3) and 12 months (t4)).</description>
    <arm_group_label>Chronic musculoskeletal pain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects between 18-70 years with chronic musculoskeletal pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (i) men / women over 18 years of age; (ii) participants with musculoskeletal pain (pain&#xD;
        intensity of 3 or more on a numerical scale of pain 0-10) will be included in this study,&#xD;
        among all of the following conditions: pain around the axial skeleton (neck, lower back And&#xD;
        / or pelvis) or peripheral joints (shoulder, elbow, wrist, knee and / or ankle). We&#xD;
        included people with clinical diagnoses of chronic pain (shoulder pain, neck pain, whiplash&#xD;
        disorder, temporomandibular joint disorders, pelvic pain syndrome, ankle pain and&#xD;
        epicondylalgia), non-specific low back pain, fibromyalgia, Chronic fatigue syndrome and&#xD;
        those with a radiological diagnosis of osteoarthritis. (iii) duration of symptoms: more&#xD;
        than 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (i) musculoskeletal pain due to traumatic or systemic inflammatory autoimmune diseases,&#xD;
        such as rheumatoid arthritis, ankylosing spondylitis, spondylolisthesis or other defined&#xD;
        rheumatological conditions; (ii) musculoskeletal pain associated with neurological&#xD;
        dysfunction (ie, multiple sclerosis or stroke), osteoporosis, hemophilia and / or cancer;&#xD;
        (iii) participants with post-fracture musculoskeletal pain; (iv) inability to provide&#xD;
        informed consent and / or complete written questionnaires.&#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>
  <location>
    <facility>
      <name>Hospital Center</name>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2021</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>Psychological factors</keyword>
  <keyword>Musculoskeletal pain</keyword>
  <keyword>Prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal 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>


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/NCT03036553
org study id: UNMalaga
nct id: NCT03036553
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic musculoskeletal pain (CMP) is highly prevalent, disabling, and with high
      socio-economic costs, with many negative effects on quality of life. CMP affects the ability
      to perform work, social, recreational and domestic tasks, changing the mood and concentration
      of this population. Despite the worldwide prevalence and socioeconomic burden of CMP, a clear
      understanding of its etiology and pathogenesis remains elusive.

      Aims:

      (i) to analyze the possible level of association between pain-related fear, fear of movement,
      self-efficacy, and pain acceptance with pain intensity and disability at the start of the
      study and prospectively evaluate its predictive function; (ii) to evaluate the possible
      mediating role of fear of movement and self-efficacy in the relationship between
      pain-disability in patients with CMP.
The present study will be a prospective multi-centric 12-month study that will be conducted
      in four primary care centers and a hospital in the province of Malaga. Several questionnaires
      assessing different psychological factors will be administered to these participants. The
      results will be evaluated at baseline (t1) and at 3 follow-up (after 3 (t2), 6 (t3) and 12
      months (t4)). Ethical approval will be obtained from the Costal del Sol Ethics Committee,
      Malaga, Spain. This study will follow the recommendations of the Declaration of Helsinki. The
      study will be implemented and reported in line with the SPIRIT statement.

      Participants A consecutive sample of CMP participants will be recruited. The general
      practitioners will carry out the recruitment. Next, the physiotherapists attending the
      research project, which will be previously instructed by the research team, will evaluate the
      participants for their eligibility. If participants meet the eligibility criteria, they will
      be invited to participate in this study, and then evaluated at baseline and 3, 6, and 12
      months of follow-up. The inclusion criteria are: (i) men / women over the age of 18; (ii)
      participants with musculoskeletal pain (pain intensity of 3 or more on a numerical scale of
      pain 0-10) will be included in this study, among all of the following conditions: pain around
      the axial skeleton (neck, lower back and / or pelvis) or peripheral joints (shoulder, elbow,
      wrist, knee and / or ankle). We included people with clinical diagnoses of chronic pain
      (shoulder pain, neck pain, whiplash disorder, temporomandibular joint disorders, pelvic pain
      syndrome, ankle pain and epicondylalgia), non-specific low back pain, fibromyalgia, chronic
      fatigue syndrome and those with a radiological diagnosis of osteoarthritis. (iii) duration of
      symptoms: more than 3 months. Exclusion criteria are as follows: (i) musculoskeletal pain due
      to traumatic or systemic inflammatory autoimmune diseases such as rheumatoid arthritis,
      ankylosing spondylitis, spondylolisthesis or other defined rheumatological conditions; (ii)
      musculoskeletal pain associated with neurological dysfunction (ie, multiple sclerosis or
      stroke), osteoporosis, hemophilia and / or cancer; (iii) participants with post-fracture
      musculoskeletal pain; (iv) inability to provide informed consent and / or complete written
      questionnaires.

      Recruitment The age and sex of those participants who refuse to participate in the project
      will be noted anonymously, with the objective of evaluating the external validity of the
      sample recruited from participants.

      Eligible participants who are interested in the study will be asked to provide written
      informed consent to participate. Participants will complete several questionnaires at
      baseline, 3, 6, and 12 months after study initiation.

      Participant data files will be stored in numerical order and in a safe and accessible place.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline the numerical pain rating scale (NRS) at 3,6,12 months
time frame: Pain will be evaluated at baseline and 3 follow-ups (3,6,12 months).
description: Pain: The Numerical Rating Scale (NRS) will assess the pain intensity of each patient at baseline and prospectively. NRS scores range from 0 to 10, with 0 without pain and 10 with the worst pain imaginable. It has been shown that the NRS has a good test-retest reliability of the same day.
measure: Change from baseline the pain disability index (PDI) at 3,6,12 months
time frame: Disability will be evaluated at baseline and 3 follow-ups (3,6,12 months).
description: Disability: The Pain Disability Index (PDI) is a 7-question questionnaire that investigates the magnitude of disability due to pain in different situations such as work, leisure time, activities of daily living, and sports
measure: Change from baseline the tampa scale for kinsiophobia (TSK-11) at 3,6,12 months
time frame: Fear of movement will be evaluated at baseline and 3 follow-ups (3,6,12 months).
description: Fear of movement: The short version of the Tampa Scale for Kinesiophobia (TSK-11) will be used to assess fear of movement
measure: Change from baseline the fear pain questionnaire (FPQ-III) at 3,6,12 months
time frame: Pain-related fear will be evaluated at baseline and 3 follow-ups (3,6,12 months).
description: Pain-related fear: The short version (9-items) of the Fear of Pain Questionnaire (FPQ-III) will be used to assess the fear of pain in this population
measure: Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 3,6,12 months
time frame: Pain acceptance will be evaluated at baseline and 3 follow-ups (3,6,12 months).
description: Pain acceptance: The Chronic Pain Acceptance Questionnaire (CPAQ) will measure pain acceptance through 20 items
measure: Change from baseline the pain self-efficacy questionnaire (PSEQ) at 3,6,12 months
time frame: Self-efficacy will be evaluated at baseline and 3 follow-ups (3,6,12 months).
description: Self-efficacy: The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
arm group label: Chronic musculoskeletal pain
description: (i) men / women over the age of 18 (ii) participants with musculoskeletal pain (pain intensity of 3 or more on a numerical scale of pain 0-10) will be included in this study, among all of the following conditions: pain around the axial skeleton (neck, lower back And / or pelvis) or peripheral joints (shoulder, elbow, wrist, knee and / or ankle). We included people with clinical diagnoses of chronic pain (shoulder pain, neck pain, whiplash disorder, temporomandibular joint disorders, pelvic pain syndrome, ankle pain and epicondylalgia), non-specific low back pain, fibromyalgia, chronic fatigue syndrome and those with a radiological diagnosis of osteoarthritis.
(iii) duration of symptoms: more than 3 months.
intervention type: Other
intervention name: Diagnosis/Prognosis
description: The present study will be a prospective multi-centric 12-month study that will be conducted between May 2017 and April 2019 in four primary care centers and a hospital in the province of Malaga. Several questionnaires assessing different psychological factors will be administered to these participants. The results will be evaluated at baseline (t1) and at 3-fold follow-up (after 3 (t2), 6 (t3) and 12 months (t4)).
arm group label: Chronic musculoskeletal pain
study pop: 
sampling method: Probability Sample
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
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Malaga
investigator full name: Alejandro Luque-Suarez
investigator title: PhD
mesh term: Musculoskeletal Pain
sharing ipd: No