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Not yet recruiting NCT07544940

Digital Health for Patellofemoral Pain

No phase Interventional PFPS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital health, Self-guided exercise.
Who it may be relevant to
Registry conditions: PFPS. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Digital Health-Based Rehabilitation for Participants With Patellofemoral Pain

Overview

This randomized controlled superiority trial will compare a 6-week digital health rehabilitation program with a 6-week self-guided exercise program in adults with patellofemoral pain. Assessments will be performed at baseline, 6 weeks, and 18 weeks. The primary outcome will be change in AKPS from baseline to 6 weeks. Secondary outcomes will include pain intensity, self-reported function, psychological outcomes, quality of life, muscle strength, adherence, and adverse events.

Interventions

  • Behavioral Digital health
    Participants will receive a 6-week digital health program delivered through a smartphone application mini-program. The intervention will include: * PFP education (condition information, pain management, load management, and activity advice) * Progressive exercise advancement according to pain response and performance * Video demonstration and structured session guidance * Symptom tracking and exercise logging * Automated reminders and adherence support * Remote therapist feedback when required
  • Behavioral Self-guided exercise
    Participants will receive a 6-week self-guided home exercise program with initial instruction delivered in printed format. Participants will be advised to perform the exercises independently at home. No ongoing digital supervision, tailored feedback, or structured adherence prompts will be provided.

Primary outcome measures

  • Anterior Knee Pain Scale [Time frame: Baseline; 6 weeks; 18 weeks]
Secondary outcome measures (4)
  • Knee injury and Osteoarthritis Outcome Score [Time frame: Baseline; 6 weeks; 18 weeks]
  • Tampa Scale for Kinesiophobia [Time frame: Baseline; 6 weeks; 18 weeks]
  • Pain Catastrophizing Scale [Time frame: Baseline; 6 weeks; 18 weeks]
  • Muscle strength [Time frame: Baseline; 6 weeks; 18 weeks]

Eligibility criteria

Inclusion criteria

  • Age 18-45 years
  • Clinical diagnosis of patellofemoral pain
  • Symptoms for at least 3 months
  • Anterior or retropatellar knee pain provoked by at least two aggravating activities such as stair ambulation, squatting, running, jumping, or prolonged sitting
  • Baseline pain intensity of at least 3/10 on the Numeric Rating Pain Scale
  • Ability to provide written informed consent and comply with study procedures

Exclusion criteria

  • Previous knee surgery
  • Patellar dislocation or obvious instability
  • Ligament injury, clinically important meniscal injury, moderate to severe knee osteoarthritis, or other major structural knee pathology
  • Major hip, ankle, or lumbar disorders substantially affecting lower-limb function
  • Neurological disorders affecting movement or balance
  • Pregnancy
  • Structured PFP rehabilitation within the previous 3 months
  • Any other condition deemed unsuitable by the investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07544940 · 2025-130-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗