- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05789095
Rate of Torque Development in Adolescents With Osgood-Schlatter
Rate of Torque Development in Adolescents With Osgood-Schlatter: A Cross-sectional Case-control Study
Osgood-Schlatter is a growth-related condition involving multiple different types of tissue in the tendon-bone interface at the tibial tubercle. Osgood-Schlatter affects one in ten adolescents causing persistent pain and reduced ability to maintain physical activities. Changes in rate of torque development is associated with decreased neuromuscular functioning and pain chronicity, thereby affecting athletic performances and general physical activities. However, changes in rate of torque development has not been investigate in patients with Osgood-Schlatter and could help characterize the condition and guide management.
The aim of the study is to investigate early and peak rate of torque development during maximal voluntary isometric knee extension and knee flexion in adolescents with Osgood-Schlatter, compared to a matched group of asymptomatic adolescents (controls), in a cross-sectional study.
The study will include 13 adolescent participants with Osgood-Schlatter and a group of 13 pain free controls matched on sex, age, and sports participation on the group level. Testing will include rate of torque measurements of knee extension and flexion for each limb with a fixated handheld dynamometer during a single test-session lasting approximately two hours. The examiner responsible for strength-testing will be blinded to case-status. Along with anthropometric data, participants will perform the anterior knee pain provocation test to assess pain-response to sustained knee loading, a countermovement jump test to assess power and jump height, and provide patient-reported measures of condition severity, pain, disability, and quality of life. Data collection will start March 2023 and is expected to finish by May 2023.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hvidovre, Denmark, 2610
- Hvidovre Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients must be 9-16 years of age
- Presence of pain for 12 weeks or more
- Pain at tibial tubercle during loading activities
- Palpable pain at the tibial tuberosity
Exclusion Criteria:
- Previous knee or hip surgery
- Other main diagnose of anterior knee pain (patellofemoral pain, Sinding-Larsen Johansson disease, Jumpers knee, etc.)
- Hip and/or back pain interfering with activities of daily living or physical activities
- Suspicion of other main diagnose such as meniscal tears and or ligamental tears
- Unable to communicate verbally or orally in Danish
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Case-group
13 adolescents, 9-16 years, with Osgood-Schlatter Disease.
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Participants and their parents/guardian receives information about the test procedures. Written informed consent is obtained before clinical examination and testing. Clinical testing is performed, anthropometric values are obtained and patient reported outcome measure is filled out, before the tests are performed. Cases will receive treatment for their condition and controls a movie ticket as compensation. |
Control-group
13 healthy adolescents, 9-16 years, without any knee pain, matched on age, sex and type of sport on the group-level.
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Participants and their parents/guardian receives information about the test procedures. Written informed consent is obtained before clinical examination and testing. Clinical testing is performed, anthropometric values are obtained and patient reported outcome measure is filled out, before the tests are performed. Cases will receive treatment for their condition and controls a movie ticket as compensation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee extension
Time Frame: Day 1
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Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
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Day 1
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Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee extension
Time Frame: Day 1
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Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
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Day 1
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Peak rate of torque development (Nm/s/kg) during maximal isometric knee extension
Time Frame: Day 1
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Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
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Day 1
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Time to peak force, during maximal isometric knee extension
Time Frame: Day 1
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Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
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Day 1
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Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee flexion
Time Frame: Day 1
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Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
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Day 1
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Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee flexion
Time Frame: Day 1
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Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
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Day 1
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Peak rate of torque development (Nm/s/kg) during maximal isometric knee flexion
Time Frame: Day 1
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Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during strength testing (NRS 10)
Time Frame: Day 1
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Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.
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Day 1
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Knee osteoarthritis Outcome Score for children (KOOS Child)
Time Frame: Day 1
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The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score, with zero representing extreme knee problems and 100 representing no knee problems. In this study participants will fill out questions from the subscales "sport/rec", "quality of life" and question P1, P4, P6b and P6b from the "pain" subscale. |
Day 1
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The Tampa Scale 17 (TSK-17)
Time Frame: Day 1
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The Tampa Scale is a 17-item questionnaire to evaluate fear avoidance behaviour in patients experiencing pain.
It consists of two subscales on activity avoidance and somatic focus.
The questions are rated on a 1-4 likert scale by the patient.
The sum of the points are ranged from 17-68, with above 37 points being defined as "high level" of kinesiophobia.
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Day 1
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Duration of pain
Time Frame: Day 1
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Participants self-reported duration of pain denoted in months
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Day 1
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Worst pain in the last week
Time Frame: Day 1
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The perceived pain in the last week, rated on the Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.
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Day 1
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Worst pain in the last 24 hours
Time Frame: Day 1
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The perceived pain in the last 24 hours, rated on the Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.
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Day 1
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Current pain
Time Frame: Day 1
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The participants current pain on the Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.
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Day 1
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Counter Movement Jump Test
Time Frame: Day 1
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The participants will perform three trials of a countermovement jump which will be recorded on a smartphone camera (>240 frames per second).
Subsequently, it will be analyzed for jump height using the MyJump 2 smartphone application.
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Day 1
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Counter Movement Jump Test
Time Frame: Day 1
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The participants will perform three trials of a countermovement jump which will be recorded on a smartphone camera (>240 frames per second).
Subsequently, it will be analyzed for power (W) using the MyJump 2 smartphone application.
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Day 1
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Pain during Counter Movement Jump Test
Time Frame: Day 1
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The participants will perform three trials of a countermovement jump.
The pain during each jump will be rated on the 0-10 Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.
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Day 1
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Anterior Knee Pain Provocation test
Time Frame: Day 1
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The participants will perform the Anterior Knee Pain Provocation test and rate the pain on the 0-10 Numerical Pain Rating Scale before and after the test.
Only the affected knee is tested.
For controls, the affected knee will be decided by coin toss.
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Day 1
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Level of sports- participation and performance compared to before knee pain
Time Frame: Day 1
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Participants are asked if they perform either 1) at a higher level than before onset of knee pain, 2) at the same level as before onset of knee pain, or 3) at a lower level than before onset of knee pain
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Day 1
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Level of physical activity compared to before knee pain
Time Frame: Day 1
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Participants are asked if they are either 1) more physically active than before onset of knee pain, 2) just as physically active as before onset of knee pain, or 3) are less physically active as before onset of knee pain
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Day 1
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-20072873
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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