Knee Cap Clinical Trial
Official title:
Feasibility Study: Does a Designated Education Session Change Levels of Catastrophizing, Kinesiophobia and Pain Beliefs in Patients With Patellofemoral Pain?
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05824676 -
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|
N/A |