- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07557784
Telerehabilitation for Patellofemoral Pain
Telerehabilitation Versus Face-to-Face Supervised Rehabilitation for Patellofemoral Pain: A Randomized Non-Inferiority Trial
Patellofemoral pain (PFP) is a common musculoskeletal condition characterized by pain around or behind the patella during activities such as stair ambulation, squatting, running, jumping, and prolonged sitting. Exercise therapy combined with patient education is considered first-line treatment, and supervised rehabilitation is commonly used to improve adherence and clinical outcomes.
Telerehabilitation may increase accessibility and reduce time and travel burden, but high-quality evidence remains limited regarding whether telerehabilitation provides outcomes that are not inferior to conventional face-to-face supervised rehabilitation in individuals with PFP.
This study is a randomized, assessor-blinded, non-inferiority trial designed to compare telerehabilitation with face-to-face supervised rehabilitation in individuals with patellofemoral pain. The trial will evaluate whether telerehabilitation is not inferior to face-to-face supervised rehabilitation in improving pain and knee-related function, while also examining psychological outcomes, self-satisfaction, and adherence.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hao-Nan Wang
- Phone Number: 8615600563019
- Email: haonanwang@aliyun.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Aged 18 to 45 years
- Clinical diagnosis of patellofemoral pain
- History of anterior or retropatellar knee pain for at least 3 months
- Pain provoked by at least two of the following activities: stair ambulation, squatting, running, jumping, or prolonged sitting
- Baseline knee pain intensity of at least 3/10 on the Numerical Rating Pain Scale
- Willing and able to participate in the rehabilitation program and follow-up assessments
- Able to provide written informed consent
Exclusion Criteria
- Previous knee surgery
- History of patellar dislocation or instability
- Evidence of ligament injury, meniscal injury requiring separate management, moderate to severe knee osteoarthritis, or other major structural knee pathology
- Concurrent hip, ankle, lumbar spine, or other musculoskeletal disorders substantially affecting lower limb function
- Neurological disorders affecting movement or balance
- Severe cardiopulmonary or systemic disease contraindicating exercise
- Received structured lower limb rehabilitation within the previous 3 months
- Pregnancy
- Any other condition judged by the investigators to make participation unsuitable
Study Plan
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 |
|---|---|
|
Experimental: Telerehabilitation Group
A 6-week remotely supervised rehabilitation program including education, progressive exercise therapy, and regular therapist-guided follow-up delivered through digital communication platforms.
|
A 6-week remotely supervised rehabilitation program including education, progressive exercise therapy, and regular therapist-guided follow-up delivered through digital communication platforms.
|
|
Active Comparator: Face-to-Face Group
A 6-week in-person supervised rehabilitation program including education, progressive exercise therapy, and regular therapist-guided follow-up.
|
A 6-week in-person supervised rehabilitation program including education, progressive exercise therapy, and regular therapist-guided follow-up.
|
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 |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
|
Numerical Rating Pain Scale
Time Frame: Baseline; 6 weeks; 18 weeks
|
Baseline; 6 weeks; 18 weeks
|
|
|
The Knee injury and Osteoarthritis Outcome Score
Time Frame: Baseline; 6 weeks; 18 weeks
|
Baseline; 6 weeks; 18 weeks
|
|
|
EQ-5D-5L
Time Frame: Baseline; 6 weeks; 18 weeks
|
Baseline; 6 weeks; 18 weeks
|
|
|
Muscle strength
Time Frame: Baseline; 6 weeks
|
Muscle strength was evaluated by maximal contractions using an isokinetic test system.
During the test, they were asked to perform five constant flexion and extension motions at their maximum effort using a concentric-concentric contractions model.
Knee muscle strength was recorded by peak torque (Nm).
|
Baseline; 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Joint Diseases
- Patellofemoral Pain Syndrome
- Health Services Administration
- Delivery of Health Care
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Telemedicine
- Patient Care Management
- Telerehabilitation
Other Study ID Numbers
- 092H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Patellofemoral Pain, PFP
-
Istanbul University - CerrahpasaRecruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Beijing Sport UniversityNot yet recruiting
-
Pamukkale UniversityNot yet recruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Beijing Sport UniversityCompletedPatellofemoral Pain, PFPChina
-
University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)CompletedPatellofemoral Pain Syndrome | Patellofemoral Pain (PFPS) | Patellofemoral Pain | Patellofemoral Pain, PFPUnited States
-
University of SalfordNorthern Care Alliance NHS Foundation TrustUnknownPatellofemoral Pain | Anterior Knee Pain | PFPUnited Kingdom
-
Cardiff Metropolitan UniversityCompletedPatellofemoral Pain, PFPUnited Kingdom
-
Ankara Medipol UniversityGazi UniversityCompleted
-
Tianjin University of SportNot yet recruiting
-
Laval UniversityCompletedPatellofemoral Pain (PFPS)Canada
Clinical Trials on Telerehabilitation
-
University of SalernoAzienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'AragonaRecruiting
-
Saglik Bilimleri UniversitesiCompletedQuality of Life | Fatigue | Muscle Weakness | Pulmonary Disease | COPD | Respiratory Disease | Dyspnea | Muscle Strength | Functional Capacity | Severe Chronic Obstructive Pulmonary Disease | Motor Imagery | Muscle; AccessoryTurkey
-
Biruni UniversityNot yet recruitingPremature Birth of Newborn | Motor Delay | Risky BabyTurkey (Türkiye)
-
Marmara UniversityCompletedHemiparetic Cerebral PalsyTurkey
-
Bright Cloud International CorpNational Cancer Institute (NCI); Rutgers, The State University of New JerseyRecruitingCognitive Impairment, MildUnited States
-
University of Eastern FinlandOulu University Hospital; Kuopio University HospitalRecruiting
-
Sakarya Applied Sciences UniversityNot yet recruitingMusculoskeletal Diseases | Postural; Defect | DriveTurkey
-
King Saud UniversityRecruitingKnee OsteoarthritisSaudi Arabia
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingCoronavirus Infections | Quality of Life | Covid19 | Respiratory Failure | ARDS | Dyspnea | Respiratory Rehabilitation | Sars-CoV-2 | Interstitial PneumoniaItaly
-
SOS Oxygene MediterraneeRecruitingExercise | Chronic Respiratory DiseaseFrance