Effect of Designated Education Session on Patellofemoral Pain
Condition: Knee Cap
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Physiotherapy + education; Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): 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.; Standard physiotherapy care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patellofemoral; Knee