<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/NCT03785561</url>
  </required_header>
  <id_info>
    <org_study_id>Study participation MSK</org_study_id>
    <nct_id>NCT03785561</nct_id>
  </id_info>
  <brief_title>Effect of Research Participation Versus Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders</brief_title>
  <official_title>Effect of Research Participation vs. Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders: Protocol for a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Frederiksberg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Frederiksberg University Hospital</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 study explores the effects on pain, function and illness perceptions, of participating&#xD;
      in clinical research versus being treated with standard care in patients with musculoskeletal&#xD;
      disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Musculoskeletal (MSK) disorders are a major burden on individuals, health systems, and social&#xD;
      care systems. Increases in life expectancy and ageing populations are expected to make MSK&#xD;
      disorders one of the leading causes of disability by the year 2020.&#xD;
&#xD;
      When faced with a potentially life changing diagnosis of a chronic disease, people (in&#xD;
      general) develop an organized pattern of perceptions about their condition, and how it&#xD;
      impacts their lives and often, the essentially same stressful event may cause significant&#xD;
      variations in perceptions. These different perceptions and coping strategies might affect the&#xD;
      way the individual chooses to handle the disease and seek health care assistance, which&#xD;
      altogether eventually may affect the course of the illness.&#xD;
&#xD;
      Study participation besides reassurance, could be hypothesized to induce beneficial outcomes&#xD;
      for the patients, but is it reasonable to expect an effect of study participation regardless&#xD;
      of study intervention, design and group allocation? And is an eventual effect mainly derived&#xD;
      from the intervention or from the participants being a selected group?&#xD;
&#xD;
      It remains to be clarified, whether and how study participation affects the individual's&#xD;
      treatment effect and perceptions of the illness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>The Brief Pain Inventory short form</measure>
    <time_frame>At baseline and end of study (&lt;=1 year)</time_frame>
    <description>The BPI measures the intensity of pain experienced within the last 24 hours and how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. In this study we will use the short version (BPI-SF). The BPI-SF is based on numerical rating scales (0-10). The arithmetic mean of the four severity items can be used as measures of pain severity. A lower score indicates less pain interference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PainDETECT questionnaire</measure>
    <time_frame>At baseline and end of study (&lt;=1 year)</time_frame>
    <description>PainDETECT questionnaire was developed to detect neuropathic pain components in adult patients. The questionnaire consists of seven questions addressing the quality of neuropathic pain symptoms; it is completed entirely by the patient. It contains seven questions that address the quality of neuropathic pain symptoms scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5), four questions addressing the pain course pattern (scored from -1 to +1) and one question concerning radiation of pain into other parts of the body (yes (+2)/no (0)). The final score between -1 and 38 indicates the likelihood of a neuropathic pain component. A score of ≤ 12 indicates that pain is unlikely to have a neuropathic component, while a score of ≥ 19 suggests that pain is likely to have a neuropathic component</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Brief Illness Perception Questionnaire</measure>
    <time_frame>At baseline and end of study (&lt;=1 year)</time_frame>
    <description>The Brief illness perception questionnaire BIPQ is a generic questionnaire developed to measure illness perception in a variety of illnesses. The questionnaire is patient-reported and assesses perceptions on the following five dimensions: Identity, Cause, Timeline, Consequences and Cure-Control. It contains eight numerical rating scales questions (0-10) and a memo field based on the patients' own beliefs about their condition. In some circumstances it may be possible to compute an overall score which represents the degree to which the illness is perceived as threatening or benign. To compute the score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8. A higher score reflects a more threatening view of the illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Widespread Pain Index</measure>
    <time_frame>At baseline and end of study (&lt;=1 year)</time_frame>
    <description>Guided by a drawing the participants indicate each area that they have felt pain in over the last week. Pain due to other known illnesses should be excluded from the assessment. There are 19 areas and the index ranges from 0 - 19, with 19 being worst. The WPI is used as part of the ACR fibromyalgia classification criteria but can be used for other pain related disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-3L</measure>
    <time_frame>At baseline and end of study (&lt;=1 year)</time_frame>
    <description>EQ-5D is a standardised measure of health status that provides a simple, generic measure of health. It is applicable to a wide range of health conditions. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews and takes only a few minutes to complete. The EQ-5D-3L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire (Disability)</measure>
    <time_frame>At baseline and end of study (&lt;=1 year)</time_frame>
    <description>HAQ-DI (HAQ-disability) contains 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided by 8. If one section is not completed by a subject, then the summed score would be divided by 7. Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1850</enrollment>
  <condition>Musculoskeletal Diseases</condition>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Illness Perceptions</condition>
  <arm_group>
    <arm_group_label>Exposed (intervention) group</arm_group_label>
    <description>Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unexposed (comparator) group</arm_group_label>
    <description>The unexposed group is defined as patients, diagnosed with a musculoskeletal disorder receiving standard clinical care at the outpatient osteoarthritis clinic at Bispebjerg and Frederiksberg Hospital. They are not currently enrolled in a health research study concerning their musculoskeletal disorder at Bispebjerg and Frederiksberg Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>participation in a health research study</intervention_name>
    <description>Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital</description>
    <arm_group_label>Exposed (intervention) group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will be based on a prospectively sampled cohort of patients from the outpatient&#xD;
        osteoarthritis clinic at Frederiksberg Hospital (approximately 1100 patients per year). The&#xD;
        OA clinic receives patients with all different kinds of musculoskeletal disorders - not&#xD;
        only OA (e.g. rheumatic -, degenerative- and inflammatory disorders in the musculoskeletal&#xD;
        system). Patients are identified and will be recruited as they come to the outpatient&#xD;
        clinic as part of any health research study or as patients not currently participating in a&#xD;
        health research study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Diagnosed with a musculoskeletal disorder&#xD;
&#xD;
          -  Currently enrolled in a health research study hosted by the outpatient osteoarthritis&#xD;
             clinic at Frederiksberg Hospital OR Being treated in the outpatient osteoarthritis&#xD;
             clinic at Frederiksberg Hospital and not participating in a health research study&#xD;
&#xD;
          -  Reads and speaks Danish&#xD;
&#xD;
          -  Consents to participation in this survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • We have no formal exclusion criteria&#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_official>
    <last_name>Henning Bliddal, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Parker institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Parker Institute, Frederiksberg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Frederiksberg University Hospital</investigator_affiliation>
    <investigator_full_name>Marius Henriksen</investigator_full_name>
    <investigator_title>PT, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Musculoskeletal Diseases</keyword>
  <keyword>Osteoarthritis, Knee</keyword>
  <keyword>cohort study</keyword>
  <keyword>illness perceptions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The Capital region of Denmark will normally only accept sharing of anonymous data</ipd_description>
  </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/NCT03785561
org study id: Study participation MSK
nct id: NCT03785561
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study explores the effects on pain, function and illness perceptions, of participating
      in clinical research versus being treated with standard care in patients with musculoskeletal
      disorders.
Musculoskeletal (MSK) disorders are a major burden on individuals, health systems, and social
      care systems. Increases in life expectancy and ageing populations are expected to make MSK
      disorders one of the leading causes of disability by the year 2020.

      When faced with a potentially life changing diagnosis of a chronic disease, people (in
      general) develop an organized pattern of perceptions about their condition, and how it
      impacts their lives and often, the essentially same stressful event may cause significant
      variations in perceptions. These different perceptions and coping strategies might affect the
      way the individual chooses to handle the disease and seek health care assistance, which
      altogether eventually may affect the course of the illness.

      Study participation besides reassurance, could be hypothesized to induce beneficial outcomes
      for the patients, but is it reasonable to expect an effect of study participation regardless
      of study intervention, design and group allocation? And is an eventual effect mainly derived
      from the intervention or from the participants being a selected group?

      It remains to be clarified, whether and how study participation affects the individual's
      treatment effect and perceptions of the illness.
observational model: Cohort
time perspective: Prospective
measure: The Brief Pain Inventory short form
time frame: At baseline and end of study (<=1 year)
description: The BPI measures the intensity of pain experienced within the last 24 hours and how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. In this study we will use the short version (BPI-SF). The BPI-SF is based on numerical rating scales (0-10). The arithmetic mean of the four severity items can be used as measures of pain severity. A lower score indicates less pain interference
measure: PainDETECT questionnaire
time frame: At baseline and end of study (<=1 year)
description: PainDETECT questionnaire was developed to detect neuropathic pain components in adult patients. The questionnaire consists of seven questions addressing the quality of neuropathic pain symptoms; it is completed entirely by the patient. It contains seven questions that address the quality of neuropathic pain symptoms scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5), four questions addressing the pain course pattern (scored from -1 to +1) and one question concerning radiation of pain into other parts of the body (yes (+2)/no (0)). The final score between -1 and 38 indicates the likelihood of a neuropathic pain component. A score of ≤ 12 indicates that pain is unlikely to have a neuropathic component, while a score of ≥ 19 suggests that pain is likely to have a neuropathic component
measure: The Brief Illness Perception Questionnaire
time frame: At baseline and end of study (<=1 year)
description: The Brief illness perception questionnaire BIPQ is a generic questionnaire developed to measure illness perception in a variety of illnesses. The questionnaire is patient-reported and assesses perceptions on the following five dimensions: Identity, Cause, Timeline, Consequences and Cure-Control. It contains eight numerical rating scales questions (0-10) and a memo field based on the patients' own beliefs about their condition. In some circumstances it may be possible to compute an overall score which represents the degree to which the illness is perceived as threatening or benign. To compute the score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8. A higher score reflects a more threatening view of the illness.
measure: Widespread Pain Index
time frame: At baseline and end of study (<=1 year)
description: Guided by a drawing the participants indicate each area that they have felt pain in over the last week. Pain due to other known illnesses should be excluded from the assessment. There are 19 areas and the index ranges from 0 - 19, with 19 being worst. The WPI is used as part of the ACR fibromyalgia classification criteria but can be used for other pain related disorders
measure: EQ-5D-3L
time frame: At baseline and end of study (<=1 year)
description: EQ-5D is a standardised measure of health status that provides a simple, generic measure of health. It is applicable to a wide range of health conditions. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews and takes only a few minutes to complete. The EQ-5D-3L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents
measure: Health Assessment Questionnaire (Disability)
time frame: At baseline and end of study (<=1 year)
description: HAQ-DI (HAQ-disability) contains 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided by 8. If one section is not completed by a subject, then the summed score would be divided by 7. Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability
arm group label: Exposed (intervention) group
description: Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital.
arm group label: Unexposed (comparator) group
description: The unexposed group is defined as patients, diagnosed with a musculoskeletal disorder receiving standard clinical care at the outpatient osteoarthritis clinic at Bispebjerg and Frederiksberg Hospital. They are not currently enrolled in a health research study concerning their musculoskeletal disorder at Bispebjerg and Frederiksberg Hospital
intervention type: Other
intervention name: participation in a health research study
description: Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital
arm group label: Exposed (intervention) group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henning Bliddal, DMSc
role: Principal Investigator
affiliation: The Parker institute
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Frederiksberg University Hospital
investigator full name: Marius Henriksen
investigator title: PT, PhD, Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Musculoskeletal Diseases
sharing ipd: Undecided
ipd description: The Capital region of Denmark will normally only accept sharing of anonymous data