Digital Health for Patellofemoral Pain

April 16, 2026 updated by: Wei-yang Zhang, Chengdu Sport University

Digital Health-Based Rehabilitation for Participants With Patellofemoral Pain

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
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.
Experimental: Digital health group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anterior Knee Pain Scale
Time Frame: Baseline; 6 weeks; 18 weeks
Baseline; 6 weeks; 18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee injury and Osteoarthritis Outcome Score
Time Frame: Baseline; 6 weeks; 18 weeks
Baseline; 6 weeks; 18 weeks
Tampa Scale for Kinesiophobia
Time Frame: Baseline; 6 weeks; 18 weeks
Baseline; 6 weeks; 18 weeks
Pain Catastrophizing Scale
Time Frame: Baseline; 6 weeks; 18 weeks
Baseline; 6 weeks; 18 weeks
Muscle strength
Time Frame: Baseline; 6 weeks; 18 weeks
Baseline; 6 weeks; 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-130-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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