<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/NCT03784339</url>
  </required_header>
  <id_info>
    <org_study_id>PatellofemoralPain_DEC2018</org_study_id>
    <nct_id>NCT03784339</nct_id>
  </id_info>
  <brief_title>Effect of Designated Education Session on Patellofemoral Pain</brief_title>
  <official_title>Feasibility Study: Does a Designated Education Session Change Levels of Catastrophizing, Kinesiophobia and Pain Beliefs in Patients With Patellofemoral Pain?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Manchester Metropolitan University</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>
      Feasibility study: Does a designated education session change levels of catastrophizing,&#xD;
      kinesiophobia and pain beliefs in patients with patellofemoral pain? Design: Single site&#xD;
      feasibility Study Aim: Aims are to identify if a formal education session (intervention)&#xD;
      improves patient outcomes and to assess if it is possible to test the intervention for&#xD;
      efficacy in a larger study.&#xD;
&#xD;
      Outcome Measures: The primary outcome measure is the Knee Osteoarthritis Outcome&#xD;
      Score-Patellofemoral) KOOS-PF. The original KOOS consists of 5 subscales; Pain, other&#xD;
      Symptoms, Activities of Daily Living (ADL), Function in sport and recreation (Sport/Rec) and&#xD;
      knee related Quality of Life (QOL). The KOOS-PF was developed to evaluate individuals or&#xD;
      samples of individuals who present with anterior knee pain/patellofemoral pain and/or&#xD;
      patellofemoral osteoarthritis (OA), or who are at risk of developing patellofemoral pain or&#xD;
      OA.&#xD;
&#xD;
      Secondary Outcome Measures are Pain Catastrophizing Scale and The Tampa Scale for&#xD;
      Kinesiophobia.&#xD;
&#xD;
      Patients who are eligible for inclusion in the study will be identified from the&#xD;
      Musculoskeletal Clinical Assessment Service (MCAS) by Band 6's and 7's and approved by a Band&#xD;
      8 Physiotherapist the South Liverpool Treatment Centre.&#xD;
&#xD;
      Intervention: The intervention will comprise a 1:1, 30 minute education session delivered by&#xD;
      a specialist musculoskeletal physiotherapist with over ten years' experience who has an&#xD;
      interest in patellofemoral pain.&#xD;
&#xD;
      The education session will be based on a schedule formed from the most recent research on&#xD;
      patellofemoral pain PFP which considers psychosocial factors (Robertson et al 2017). Crepitus&#xD;
      is a word used to describe any grinding, creaking, cracking, grating, crunching or popping&#xD;
      that occurs when the patellofemoral joint moves (Robertson et al 2017). The psychological&#xD;
      factors, specifically patients' beliefs about crepitus, avoiding crepitus and the influence&#xD;
      of others will be discussed.&#xD;
&#xD;
      The intervention will be supported by the leaflet 'managing my patellofemoral pain' developed&#xD;
      by Barton and Rathleff (2016) on the basis of international opinion from 21 international&#xD;
      experts and subsequent review by 20 patients diagnosed with PFP to ensure clarity.&#xD;
&#xD;
      Duration: Within the time constraints of a Masters Degree, patients will be recruited over a&#xD;
      four month period. There will be four months for follow up and a further four months for&#xD;
      write up, total study duration 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: A feasibility study to assess if a physiotherapy education session in addition to&#xD;
      standard care improves patients scores regarding catastrophizing and kinesiophobia when&#xD;
      measured by KOOS-PF, Pain Catastrophizing Scale and Tampa Scale&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To assess if providing a specific education session which reviews patients beliefs about&#xD;
           crepitus, causes of pain, joint mechanics and purpose of exercise has an effect on&#xD;
           catastrophizing and kinesiophobia.&#xD;
&#xD;
        2. To identify if the study is feasible on a larger scale, which would allow the&#xD;
           intervention to be assessed for efficacy. If a future study was able to demonstrate that&#xD;
           the intervention was effective this would provide an additional evidence based&#xD;
           intervention for use in clinical practice.&#xD;
&#xD;
      Recruitment: NHS patients diagnosed in a Musculoskeletal Clinical Assessment Service [MCAS]&#xD;
      with patellofemoral pain at the South Liverpool Treatment Centre.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Adults aged 18-40&#xD;
&#xD;
        -  Be able to understand and converse in English&#xD;
&#xD;
        -  Clinical diagnosis of PFP&#xD;
&#xD;
        -  Be able to attend for up-to 12 weeks of physiotherapy&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Patients who present with referred pain from the spine or hip, or have tibiofemoral&#xD;
           pathology of any nature on the ipsilateral side.&#xD;
&#xD;
        -  A diagnosis of patellofemoral joint (PFJ) OA as confirmed by X-Ray or Magnetic Resonance&#xD;
           Imaging (MRI).&#xD;
&#xD;
      Sample size: There is limited published research regarding the use of the questionnaire&#xD;
      KOOS-PF in research. As a result it is not possible to do a definitive study to test whether&#xD;
      or not the education session effects patient outcome. Therefore it is necessary to do a&#xD;
      feasibility study with a small sample size of 24 patients (control n=12, intervention n=12)&#xD;
      which will allow any change in the questionnaire scores to be used to calculate how many&#xD;
      patients would be needed for a definitive study which would allow researchers to assess&#xD;
      whether or not the exercise intervention affected patient outcome, which could improve&#xD;
      patient care. The research team are confident that the required number of patients could be&#xD;
      recruited as audit data from the service identified that 104 patients in the MCAS service met&#xD;
      the criteria for inclusion in this proposed study.&#xD;
&#xD;
      Baseline measures: Participants' characteristics including age, gender and duration of&#xD;
      symptoms will be collected alongside baseline measures for the chosen questionnaires - the&#xD;
      KOOS-PF, Tampa-scale for Kinesiophobia and Pain Catastrophizing. These questionnaires will be&#xD;
      repeated at 12 weeks.&#xD;
&#xD;
      Intervention: Patients recruited into the study will be randomised to either the intervention&#xD;
      (n=12) or the control group (n=12). Participants in the control group will undergo standard&#xD;
      treatment.&#xD;
&#xD;
      The intervention: Participants in the intervention group will receive standard treatment plus&#xD;
      the education session.&#xD;
&#xD;
      The education session will be based on a leaflet produced by other leading researchers in the&#xD;
      field and will also explore the causes of pain, beliefs about pain, beliefs about noise that&#xD;
      come from the joint, the impact of the pain on activity and the influence of other family&#xD;
      members' experience and beliefs about knee pain. At 12 weeks, participants from both groups&#xD;
      will be asked to repeat the questionnaires.&#xD;
&#xD;
      Statistical analysis: Descriptive statistical analysis will be performed on the data and the&#xD;
      lead researcher will work with the statistics department at MMU to review the change in the&#xD;
      chosen questionnaires to identify the sample size required for a definitive study which will&#xD;
      assess how effective the education session is on patients' symptoms of PFP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2019</start_date>
  <completion_date type="Actual">November 29, 2019</completion_date>
  <primary_completion_date type="Actual">August 13, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)</measure>
    <time_frame>12 weeks following baseline visit</time_frame>
    <description>The KOOS-PF is an 11 item, patient reported outcome measure of pain and function where a maximum score of 100 indicates no problems and a minimum score of 0 indicates extreme problems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tampa Scale for Kinesiophobia (TSK)</measure>
    <time_frame>12 weeks following baseline visit</time_frame>
    <description>The TSK is a 17-item patient reported outcome measure of fear of movement. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>12 weeks following baseline visit</time_frame>
    <description>The PCS is a 13 item patient reported outcome measure where the PCS total score is computed by summing the responses to all 13 items. PCS total scores range from 0 - 52, with higher scores indicating greater pain catastrophizing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Knee Cap</condition>
  <arm_group>
    <arm_group_label>Physiotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive standard physiotherapy care, which will involve strength exercises and taping.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiotherapy + education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physiotherapy + education Standard physiotherapy care plus 30 minute education session addressing fear of movement and catastrophizing thoughts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy + education</intervention_name>
    <description>Participants will take part in a 30 minute education session surrounding fear of movement and catastrophizing thoughts. They will then receive standard care, which will involve strength exercises and taping if needed.</description>
    <arm_group_label>Physiotherapy + education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>Standard physiotherapy care</description>
    <arm_group_label>Physiotherapy</arm_group_label>
    <arm_group_label>Physiotherapy + education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-40&#xD;
&#xD;
          -  Be able to understand and converse in English&#xD;
&#xD;
          -  Clinical diagnosis of PFPS&#xD;
&#xD;
          -  Be able to attend for up-to 12 weeks of physiotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who present with referred pain from the spine or hip, or have tibiofemoral&#xD;
             pathology of any nature on the ipsilateral side.&#xD;
&#xD;
          -  A diagnosis of PFJ osteoarthritis as confirmed by X-Ray or MRI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Selfe</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Liverpool &amp; Broadgreen University Hospitals Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Manchester Metropolitan University</investigator_affiliation>
    <investigator_full_name>James Selfe, DSc</investigator_full_name>
    <investigator_title>Professor of Health Professions</investigator_title>
  </responsible_party>
  <keyword>Patellofemoral</keyword>
  <keyword>Knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</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/NCT03784339
org study id: PatellofemoralPain_DEC2018
nct id: NCT03784339
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Feasibility study: Does a designated education session change levels of catastrophizing,
      kinesiophobia and pain beliefs in patients with patellofemoral pain? Design: Single site
      feasibility Study Aim: Aims are to identify if a formal education session (intervention)
      improves patient outcomes and to assess if it is possible to test the intervention for
      efficacy in a larger study.

      Outcome Measures: The primary outcome measure is the Knee Osteoarthritis Outcome
      Score-Patellofemoral) KOOS-PF. The original KOOS consists of 5 subscales; Pain, other
      Symptoms, Activities of Daily Living (ADL), Function in sport and recreation (Sport/Rec) and
      knee related Quality of Life (QOL). The KOOS-PF was developed to evaluate individuals or
      samples of individuals who present with anterior knee pain/patellofemoral pain and/or
      patellofemoral osteoarthritis (OA), or who are at risk of developing patellofemoral pain or
      OA.

      Secondary Outcome Measures are Pain Catastrophizing Scale and The Tampa Scale for
      Kinesiophobia.

      Patients who are eligible for inclusion in the study will be identified from the
      Musculoskeletal Clinical Assessment Service (MCAS) by Band 6's and 7's and approved by a Band
      8 Physiotherapist the South Liverpool Treatment Centre.

      Intervention: The intervention will comprise a 1:1, 30 minute education session delivered by
      a specialist musculoskeletal physiotherapist with over ten years' experience who has an
      interest in patellofemoral pain.

      The education session will be based on a schedule formed from the most recent research on
      patellofemoral pain PFP which considers psychosocial factors (Robertson et al 2017). Crepitus
      is a word used to describe any grinding, creaking, cracking, grating, crunching or popping
      that occurs when the patellofemoral joint moves (Robertson et al 2017). The psychological
      factors, specifically patients' beliefs about crepitus, avoiding crepitus and the influence
      of others will be discussed.

      The intervention will be supported by the leaflet 'managing my patellofemoral pain' developed
      by Barton and Rathleff (2016) on the basis of international opinion from 21 international
      experts and subsequent review by 20 patients diagnosed with PFP to ensure clarity.

      Duration: Within the time constraints of a Masters Degree, patients will be recruited over a
      four month period. There will be four months for follow up and a further four months for
      write up, total study duration 12 months.
Design: A feasibility study to assess if a physiotherapy education session in addition to
      standard care improves patients scores regarding catastrophizing and kinesiophobia when
      measured by KOOS-PF, Pain Catastrophizing Scale and Tampa Scale

      Objectives:

        1. To assess if providing a specific education session which reviews patients beliefs about
           crepitus, causes of pain, joint mechanics and purpose of exercise has an effect on
           catastrophizing and kinesiophobia.

        2. To identify if the study is feasible on a larger scale, which would allow the
           intervention to be assessed for efficacy. If a future study was able to demonstrate that
           the intervention was effective this would provide an additional evidence based
           intervention for use in clinical practice.

      Recruitment: NHS patients diagnosed in a Musculoskeletal Clinical Assessment Service [MCAS]
      with patellofemoral pain at the South Liverpool Treatment Centre.

      Inclusion criteria:

        -  Adults aged 18-40

        -  Be able to understand and converse in English

        -  Clinical diagnosis of PFP

        -  Be able to attend for up-to 12 weeks of physiotherapy

      Exclusion criteria:

        -  Patients who present with referred pain from the spine or hip, or have tibiofemoral
           pathology of any nature on the ipsilateral side.

        -  A diagnosis of patellofemoral joint (PFJ) OA as confirmed by X-Ray or Magnetic Resonance
           Imaging (MRI).

      Sample size: There is limited published research regarding the use of the questionnaire
      KOOS-PF in research. As a result it is not possible to do a definitive study to test whether
      or not the education session effects patient outcome. Therefore it is necessary to do a
      feasibility study with a small sample size of 24 patients (control n=12, intervention n=12)
      which will allow any change in the questionnaire scores to be used to calculate how many
      patients would be needed for a definitive study which would allow researchers to assess
      whether or not the exercise intervention affected patient outcome, which could improve
      patient care. The research team are confident that the required number of patients could be
      recruited as audit data from the service identified that 104 patients in the MCAS service met
      the criteria for inclusion in this proposed study.

      Baseline measures: Participants' characteristics including age, gender and duration of
      symptoms will be collected alongside baseline measures for the chosen questionnaires - the
      KOOS-PF, Tampa-scale for Kinesiophobia and Pain Catastrophizing. These questionnaires will be
      repeated at 12 weeks.

      Intervention: Patients recruited into the study will be randomised to either the intervention
      (n=12) or the control group (n=12). Participants in the control group will undergo standard
      treatment.

      The intervention: Participants in the intervention group will receive standard treatment plus
      the education session.

      The education session will be based on a leaflet produced by other leading researchers in the
      field and will also explore the causes of pain, beliefs about pain, beliefs about noise that
      come from the joint, the impact of the pain on activity and the influence of other family
      members' experience and beliefs about knee pain. At 12 weeks, participants from both groups
      will be asked to repeat the questionnaires.

      Statistical analysis: Descriptive statistical analysis will be performed on the data and the
      lead researcher will work with the statistics department at MMU to review the change in the
      chosen questionnaires to identify the sample size required for a definitive study which will
      assess how effective the education session is on patients' symptoms of PFP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)
time frame: 12 weeks following baseline visit
description: The KOOS-PF is an 11 item, patient reported outcome measure of pain and function where a maximum score of 100 indicates no problems and a minimum score of 0 indicates extreme problems.
measure: Tampa Scale for Kinesiophobia (TSK)
time frame: 12 weeks following baseline visit
description: The TSK is a 17-item patient reported outcome measure of fear of movement. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
measure: Pain Catastrophizing Scale (PCS)
time frame: 12 weeks following baseline visit
description: The PCS is a 13 item patient reported outcome measure where the PCS total score is computed by summing the responses to all 13 items. PCS total scores range from 0 - 52, with higher scores indicating greater pain catastrophizing
arm group label: Physiotherapy
arm group type: Placebo Comparator
description: Participants will receive standard physiotherapy care, which will involve strength exercises and taping.
arm group label: Physiotherapy + education
arm group type: Experimental
description: Physiotherapy + education Standard physiotherapy care plus 30 minute education session addressing fear of movement and catastrophizing thoughts.
intervention type: Other
intervention name: Physiotherapy + education
description: Participants will take part in a 30 minute education session surrounding fear of movement and catastrophizing thoughts. They will then receive standard care, which will involve strength exercises and taping if needed.
arm group label: Physiotherapy + education
intervention type: Other
intervention name: Physiotherapy
description: Standard physiotherapy care
arm group label: Physiotherapy
arm group label: Physiotherapy + education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: James Selfe
role: Study Chair
affiliation: Professor
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Manchester Metropolitan University
investigator full name: James Selfe, DSc
investigator title: Professor of Health Professions
mesh term: Patellofemoral Pain Syndrome
sharing ipd: No