Clinical trial NCT05789095: Rate of Torque Development in Adolescents With Osgood-Schlatter
Official title: Rate of Torque Development in Adolescents With Osgood-Schlatter: A Cross-sectional Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osgood-Schlatter Disease
Keywords: Adolescents
Rate of torque development
Osgood-Schlatter
Neuromuscular
Inhibition
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 26
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents aged 9-16 residing in the uptake area of Copenhagen University Hospital, Amager-Hviodvre (1.8m total residents), who is made aware of the study be either 1) being referred to the orthopedic department for Osgood-Schlatter, 2) sees adverts and local sports clubs, or 3) sees the online advert on the research unit webpage

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee extension
timeFrame: Day 1
measure: Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee extension
timeFrame: Day 1
measure: Peak rate of torque development (Nm/s/kg) during maximal isometric knee extension
timeFrame: Day 1
measure: Time to peak force, during maximal isometric knee extension
timeFrame: Day 1
measure: Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee flexion
timeFrame: Day 1
measure: Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee flexion
timeFrame: Day 1
measure: Peak rate of torque development (Nm/s/kg) during maximal isometric knee flexion
timeFrame: Day 1
Secondary outcomes:
measure: Pain during strength testing (NRS 10)
timeFrame: Day 1
Other outcomes:
measure: Knee osteoarthritis Outcome Score for children (KOOS Child)
timeFrame: Day 1
measure: The Tampa Scale 17 (TSK-17)
timeFrame: Day 1
measure: Duration of pain
timeFrame: Day 1
measure: Worst pain in the last week
timeFrame: Day 1
measure: Worst pain in the last 24 hours
timeFrame: Day 1
measure: Current pain
timeFrame: Day 1
measure: Counter Movement Jump Test
timeFrame: Day 1
measure: Counter Movement Jump Test
timeFrame: Day 1
measure: Pain during Counter Movement Jump Test
timeFrame: Day 1
measure: Anterior Knee Pain Provocation test
timeFrame: Day 1
measure: Level of sports- participation and performance compared to before knee pain
timeFrame: Day 1
measure: Level of physical activity compared to before knee pain
timeFrame: Day 1
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
References: