PFPSNCT07544940
Digital Health for Patellofemoral Pain
A study testing Digital health and Self-guided exercise in people with PFPS, run by Chengdu Sport University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- PFPS
- What is being tested?
- Digital health and Self-guided exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 15 May 2027
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- PFPS
- Being tested
- Digital health, Self-guided exercise
- Keywords
- PFP, rehabilitation, digital health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital healthBehavioural
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
Self-guided exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital health group | Experimental | Not described Receives: Behavioral: Digital health |
| Control group | Active comparator | Not described Receives: Behavioral: Self-guided exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Knee Pain Scale
Measured: Baseline; 6 weeks; 18 weeks
Secondary outcomes (4)
Knee injury and Osteoarthritis Outcome Score
Measured: Baseline; 6 weeks; 18 weeks
Tampa Scale for Kinesiophobia
Measured: Baseline; 6 weeks; 18 weeks
Pain Catastrophizing Scale
Measured: Baseline; 6 weeks; 18 weeks
Muscle strength
Measured: Baseline; 6 weeks; 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFPSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-yang Zhang, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544940
- Sponsor's protocol ID
- 2025-130-A
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health-Based Rehabilitation for Participants With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT07544940
- Acronym / sponsor ID
- 2025-130-A
- Conditions
- PFPS
- Keywords
- PFP, rehabilitation, digital health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital health group | Experimental | Behavioral: Digital health |
| Control group | Active comparator | Behavioral: Self-guided exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital healthParticipants 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 | Behavioural | Digital health group |
| Self-guided exerciseParticipants 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. | Behavioural | Control group |
Primary outcome
Anterior Knee Pain Scale
Time frame: Baseline; 6 weeks; 18 weeks
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Digital health and Self-guided exercise in people with PFPS, run by Chengdu Sport University.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Wei-Yang Zhang (8615196279571, weiyangz@cdsu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Knee Pain Scale (time frame: Baseline; 6 weeks; 18 weeks). 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 22 Apr 2026.