Digital Health for Patellofemoral Pain

NCT07544940 | Not Yet Recruiting DMC

• 1 other identifier: 2025-130-A
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PFPS

Keywords

PFP; rehabilitation; digital health

Outcome Measures

Primary Outcomes (1)

• Anterior Knee Pain Scale

  Baseline; 6 weeks; 18 weeks

Secondary Outcomes (4)

• Knee injury and Osteoarthritis Outcome Score

  Baseline; 6 weeks; 18 weeks

• Tampa Scale for Kinesiophobia

  Baseline; 6 weeks; 18 weeks

• Pain Catastrophizing Scale

  Baseline; 6 weeks; 18 weeks

• Muscle strength

  Baseline; 6 weeks; 18 weeks

Study Arms (2)

Digital health group

EXPERIMENTAL

Behavioral: Digital health

Control group

ACTIVE COMPARATOR

Behavioral: Self-guided exercise

Interventions

Digital health BEHAVIORAL

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

Digital health group

Self-guided exercise BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu Sport University: lead

MeSH Terms

Interventions

Digital Health

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Wei-Yang Zhang

CONTACT

8615196279571; weiyangz@cdsu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share