About this trial
This study aims to validate a function-based physiotherapy assessment for subacute knee pain without using specific knee tests. Assessments are conducted either in-person or via video consultations in primary care. The study also compares the reliability of digital versus physical assessments to determine if video-based evaluations can provide sufficient diagnostic support and guide treatment decisions.
The main questions this study aims to answer are:
1. Is a function-based knee assessment without specific knee tests valid compared to traditional in-person diagnostics using specific tests? 2. Is a video-based assessment based on history and function-based knee assessment without specific knee tests as valid and reliable as an in-person function-based knee assessment? 3. What is the interrater agreement of function-based knee assessments conducted via video compared to those conducted in person?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Subacute knee symptoms (onset more than one week ago but less than three months ago)
Sufficient proficiency in written and spoken Swedish to complete forms and describe symptoms; no need for interpreter
Access to digital technology (e.g., computer or smartphone)
Disqualifiers
Prior assessment for current knee symptoms (by rehab clinic, physician, emergency care, or urgent care)
Knee or hip replacement surgery within the past year
Other knee surgeries (ACL, meniscus, ligament) within the past year
Inability to walk independently, with or without walking aids
Trial design
Single group
Treatments tested in this trial
Physiotherapy digital assessment
Diagnostic testThis study involves three types of knee assessments to evaluate diagnostic reliability and validity: (1) a video-based function-based examination without specific knee tests, (2) traditional in-person function-based examination without specific knee tests and to control with (3) a traditional in-person examination including specific knee tests. The video-based assessment includes standardized history taking and functional evaluation conducted via clinic software, with the physiotherapist and participant in separate rooms. Physiotherapists provide diagnostic judgments after each assessment phase. All procedures follow standardized protocols, pilot-tested and conducted at a public rehabilitation clinic in Västra Götaland.
Physiotherapy assessment - only functional tests
Diagnostic testThis study involves three types of knee assessments to evaluate diagnostic reliability and validity: (1) a video-based function-based examination without specific knee tests, (2) traditional in-person function-based examination without specific knee tests and to control with (3) a traditional in-person examination including specific knee tests. The in-person assessments (2 and 3) includes the same functional tests plus specific tests targeting knee structures (ligaments, meniscus etc). Physiotherapists provide diagnostic judgments after each assessment phase. All procedures follow standardized protocols, pilot-tested and conducted at a public rehabilitation clinic in Västra Götaland.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Agreement in Diagnostic Categories from Functional In-Person Assessment
Primary outcome is whether the system-level diagnosis (diagnostic category) assigned by the physiotherapist matches across in-person assessments with or without specific tests - functional assessment compared to traditional assessment with specific tests. Diagnoses are categorized into five predefined groups: ligament, meniscus, joint-related, soft tissue, and other. Within each category, physiotherapists assign specific ICD-10 codes. Outcome is measured as match/mismatch between diagnostic categories.
Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History
Primary outcome is whether the system-level diagnosis (diagnostic category) assigned by the physiotherapist matches across digital assessment with only patient history compared with traditional in person assessment with specific tests. Diagnoses are categorized into five predefined groups: ligament, meniscus, joint-related, soft tissue, and other. Within each category, physiotherapists assign specific ICD-10 codes. Outcome is measured as match/mismatch between diagnostic categories.
Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History and Functional Evaluation
Primary outcome is whether the system-level diagnosis (diagnostic category) assigned by the physiotherapist matches across digital assessment with traditional in person assessment with specific tests. Diagnoses are categorized into five predefined groups: ligament, meniscus, joint-related, soft tissue, and other. Within each category, physiotherapists assign specific ICD-10 codes. Outcome is measured as match/mismatch between diagnostic categories.
Number of participants with agreement in test results of functional assessment
Primary outcome is whether the test results from the functional tests performed in the video consultation differs from in-person functional assessment.
Secondary outcomes
Degree of diagnostic certainty
After each assessment, the physiotherapists will rate their level of diagnostic certainty on a scale from 0 (not confident) to 100 (fully confident), for a total of four ratings. A) digital patient history assessment B) digital functional assessment C) in-person functional assessment D) in-person specific tests
Number of Participants with Agreement on Specific Diagnostic Categories
The physiotherapists will diagnose with pre-defined ICD-10 diagnoses. All assessments will be compared on a specific diagnostic level.
Patient-Rated Satisfaction With the Assessment
Patient satisfaction will be measured after each knee assessment session using a modified item from the Swedish instrument "Quality from the Patient's Perspective" (QPP). The selected item is: "I received the best possible examination (as far as I can judge myself)." Patients rate their agreement on a 5-point Likert scale: Strongly agree, Mostly agree, Partly agree, Do not agree at all, and Not applicable. The response is collected via a secure web-based form.
Adverse events
Other outcomes
Demographic data
Background information about each participant will be collected. Collected data includes age, sex, origin, height, weight, experience of knee symptoms, pain intensity, pain duration, previous experience with video consultations, travel distance (in kilometers) between home/start point and the clinic, and results from the knee assessments. Travel distance is recorded to enable analysis of transport and environmental aspects.
Knee Pain Intensity Measured by Numeric Rating Scale (NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where participants rate their current knee pain, average pain over the past week, and the lowest and highest pain intensity experienced during the past week. Ratings are given on a scale from 0 (no pain) to 10 (worst imaginable pain). NRS has strong correlation with the Visual Analog Scale (VAS) and demonstrates high reliability (intraclass correlation coefficient = 0.95). The minimal detectable change is 1.3.
Knee Injury and Osteoarthritis Outcome Score - 12 Items (KOOS-12)
KOOS-12 is a shortened version of the original KOOS instrument, consisting of 12 items across three dimensions: pain, function, and quality of life. Each item is scored from 0 (no problems) to 4 (extreme problems). Scores for each dimension are summed and converted to a 0-100 scale, where lower scores indicate more severe symptoms and higher scores indicate milder symptoms. KOOS-12 has demonstrated good reliability, validity, and responsiveness.
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