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

NCT06744257 | Recruiting

• 1 other identifier: 21/228
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patello Femoral Syndrome

Keywords

Knee pain; Physiotherapy; Patellofemoral knee pain

Outcome Measures

Primary Outcomes (7)

• Recruitment and eligbility

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

  From recruitment until end of follow up at 6 weeks.

• 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.

  From recruitment until end of follow up at 6 weeks.

• 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.

  From recruitment until end of follow-up at 6 weeks

• Attrition rate

  A maximum 20% attrition rate in either arm.

  From recruitment until end of follow-up at 6 weeks

• Data collection

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

  From recruitment until end of follow up at 6 weeks

• NPRS scoring

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

  From recruitment until end of follow up at 6 weeks.

• EQ-5D-5L (EuroQol Group-5 dimensions-5 levels)

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

  From recruitment until end of follow up at 6 weeks.

Study Arms (2)

Online exercise program

EXPERIMENTAL

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.

Other: Online Education tool

Standard of Care

NO INTERVENTION

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.

Interventions

Online Education tool OTHER

An online education tool that contains 4 modules

Online exercise program

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Suffolk and North Essex NHS Foundation Trust: lead

Study Sites (1)

East Suffolk and North Essex NHS Foundation Trust

Colchester, CO4 5JL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Bradley Neal

CONTACT

01473 704343; R&D@esneft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Prinicipal Investigator of the study will be blinded to all individual participant information and only have access to unique pseudonymised study numbers/ data and which group they are assigned too.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 20, 2024
• Study Start: November 28, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

GB (1)