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AzTrials

Patello Femoral SyndromeOPENNCT06744257

Is Online Patient EducatioN Feasible in People With Patellofemoral Pain Whilst They Wait for Physiotherapy

A study testing Online Education tool in people with Patello Femoral Syndrome, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary aim is to determine if online patient education is a feasible intervention for people with PFP awaiting physiotherapy. The secondary aim is to provide outcome data to inform a future substantiative trial. Read more about this study

Who is it for?
Ages 16 to 44 years
Conditions the study is for
Patello Femoral Syndrome
What is being tested?
Online Education tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
28 Nov 2024to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 44 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Aged 18-44 years
  • Gradual onset retro-and/or peri-patellar pain
  • Symptoms reproduced during one or more of running; jumping; stair ambulation; squatting
  • Referred to East Suffolk and North Essex NHS Foundation Trust for outpatient physiotherapy at Colchester hospital
  • Able to read and understand written/spoken English

Who cannot join

  • Aged 45 years and older
  • Symptoms of concomitant knee pathology
  • Symptoms commencing after trauma or knee surgery
  • Presentation inconsistent with patellofemoral pain during clinical examination
  • Unable to understand written/spoken English
  • Unable to give informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bradley Neal contact

01473 704343

R&D@esneft.nhs.uk

United Kingdom1 site, 1 recruiting
  • East Suffolk and North Essex NHS Foundation Trust

    Colchester, CO4 5JL

    Bradley Neal, 01473 703885, R&D@esneft.nhs.uk

    Bradley Neal

    Recruiting

Other trials in United Kingdom

About this study

The primary aim is to determine if online patient education is a feasible intervention for people with PFP awaiting physiotherapy. The secondary aim is to provide outcome data to inform a future substantiative trial.

Read the detailed description

Participants will take part in a feasibility trial whilst they are on the ESNEFT physiotherapy waiting list to avoid disrupting their routine care.

Participants will first attend a face-to-face eligibility assessment to validate their diagnosis of PFP, before being randomised to one of two arms:

  1. The online education arm will be provided with password access to our online patient education platform (https://www.teampfp.com/my-knee-cap-pain) that contains four modules; [a] Understand your pain; [b] How do I start to exercise; [c] Treatment options; [d] Case studies. The aim of each module is to provide people with knowledge they can put into practice (experiential learning) and facilitating their self-management. A short quiz at the end of each module assesses user engagement and knowledge retention. Investigators developed these modules alongside members of the International Patellofemoral Research Network, and people with PFP that attended a PPI event at Queen Mary University London (QMUL) that aimed to understand what information people with PFP wanted to help them self-manage their condition. Participants randomised to the online education group will be instructed to consume the content at their own pace (with one module/week advised) and that their adherence will be determined by monitoring their completion of each end of module quiz. Participants with no access to a device or the internet, will be given a paper version.
  2. The control arm will receive no additional care whilst on the ESNEFT physiotherapy waiting list. Their involvement in the trial will end at six-weeks follow up and they will then be provided with access to the online education platform if they request it.

The feasibility outcomes, adapted from those used in recent trials and mapped to trial quality appraisal scales, are designed to inform us on the willingness of clinicians to recruit participants, the willingness of participants to be randomised, if participants will accept and adhere to patient education intervention, if sufficient data can be collected, and potential effects of online education. Outcomes informing intervention effects have been optimised after discussion with participants from two pre-trial PPI focus groups. Outcome measures will be collected using the good data protection regulations (GDPR) compliant REDCap system (https://www.project-redcap.org/). Participants will receive regular prompts and paper versions with stamped/addressed envelopes will be available to those who are digitally illiterate, supported by a research assistant.

  1. Recruitment and eligibility; a recruitment rate of four eligible participants per month is targeted, with consent rate (eligible/consenting participants) calculated
  2. Randomisation and blinding; broad equality of baseline characteristics between groups and acceptable outcome assessor blinding will be targeted
  3. Adherence and acceptability; >75% of participants in the online education arm attempting the end of education module quizzes and acceptability meaningfully greater than remaining on a waiting list
  4. A maximum 20% attrition rate in either arm
  5. Data collection; with >85% of participants completing all outcome measures at six-week follow up targeted.
  6. The 7-point Likert global rating of change (GROC) scale will be used to allow comparison to recent RCTs involving people with PFP. Categories will be: [1] much better, [2] better, [3] a little better, [4] no change, [5] a little worse [6] much worse, and [7] markedly worse. Successful outcome will be dichotomised and defined a priori as [1] much better or [2] better at six-weeks follow up.
  7. An eleven-point numerical pain rating scale (NPRS) will assess worst pain in the past week, which is valid and responsive in people with PFP 9.
  8. The reliable and responsive EQ-5D-5L will assess health-related quality of life; important for future cost-effectiveness analyses 16. The final question of EQ-5D-5L relates to anxiety/depression. If participants select severely or extremely anxious or depressed, the investigators will inform the participant's GP.

Investigators will invite a subset of participants randomised to the online education arm to participate in a maximum of two semi-structured focus groups (n=6 per group) or 1:1 interviews post-trial. The aim of these focus groups will be to explore their perspectives on participating in our feasibility trial and receiving our online patient education intervention. Investigators will specifically explore the factors that affected if participants felt they had benefitted from receiving online patient education, and whether further physiotherapy input was still required. These semi-structured focus groups will be conducted by co-applicant Dr Katharine Fowler.

Being tested
Online Education tool
Keywords
Knee pain, Physiotherapy, Patellofemoral knee pain
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Education toolOther

    An online education tool that contains 4 modules

Study groups in NCT06744257
Study groupRoleWhat they receive
Online exercise programExperimentalThe online education arm will be provided with password access to our online patient education platform (https://www.teampfp.com/my-knee-cap-pain) that contains four modules; [a] Understand your pain; [b] How do I start to exercise; [c] Treatment options; [d] Case studies. The aim of each module is to provide people with knowledge they can put into practice (experiential learning) and facilitating their self-management. A short quiz at the end of each module assesses user engagement and knowledge retention.
Receives: Other: Online Education tool
Standard of CareNo interventionThe control arm will receive no additional care whilst on the ESNEFT physiotherapy waiting list. Their involvement in the trial will end at six-weeks follow up and they will then be provided with access to the online education platform if they request it.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment and eligbility

    A recruitment rate of four eligible participants per month is targeted, with consent rate (eligible/consenting participants) calculated.

    Measured: From recruitment until end of follow up at 6 weeks.

  2. 7-point likert scale

    We will use the 7-point Likert global rating of change (GROC) scale with categories: [1] much better, [2] better, [3] a little better, [4] no change, [5] a little worse [6] much worse, and [7] markedly worse. Successful outcome will be dichotomised and defined a priori as [1] much better or [2] better.

    Measured: From recruitment until end of follow up at 6 weeks.

  3. Adherence and acceptability rate

    >75% of participants in the online education arm attempting the end of education module quizzes and acceptability meaningfully greater than remaining on a waiting list.

    Measured: From recruitment until end of follow-up at 6 weeks

  4. Attrition rate

    A maximum 20% attrition rate in either arm.

    Measured: From recruitment until end of follow-up at 6 weeks

  5. Data collection

    With >85% of participants completing all outcome measures at six-week follow up targeted.

    Measured: From recruitment until end of follow up at 6 weeks

  6. NPRS scoring

    An eleven-point numerical pain rating scale (NPRS) will assess worst pain in the past week.

    Measured: From recruitment until end of follow up at 6 weeks.

  7. EQ-5D-5L (EuroQol Group-5 dimensions-5 levels)

    The reliable and responsive EQ-5D-5L will assess health-related quality of life.

    Measured: From recruitment until end of follow up at 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start28 Nov 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744257
Sponsor's protocol ID
21/228
Acronym
OPEN
Status last verified
Feb 2026
First submitted
22 Nov 2024
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Online Education tool in people with Patello Femoral Syndrome, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bradley Neal (01473 704343, R&D@esneft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment and eligbility (time frame: From recruitment until end of follow up at 6 weeks.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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