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NCT Number: NCT05789095

Rate of Torque Development in Adolescents With Osgood-Schlatter

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.

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Key information

Conditions

Osgood-Schlatter Disease Behavior Bone Diseases Inhibition, Psychological Musculoskeletal Diseases Osteochondrosis

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital

Hvidovre, 2610, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz)

Other

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.

Primary outcomes

  1. Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee extension

    Time frame: Day 1

    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.

  2. Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee extension

    Time frame: Day 1

    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.

  3. Peak rate of torque development (Nm/s/kg) during maximal isometric knee extension

    Time frame: Day 1

    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.

  4. Time to peak force, during maximal isometric knee extension

    Time frame: Day 1

    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.

  5. Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee flexion

    Time frame: Day 1

    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.

  6. Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee flexion

    Time frame: Day 1

    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.

  7. Peak rate of torque development (Nm/s/kg) during maximal isometric knee flexion

    Time frame: Day 1

    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.

Secondary outcomes

  1. Pain during strength testing (NRS 10)

    Time frame: Day 1

    Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.

Other outcomes

  1. Knee osteoarthritis Outcome Score for children (KOOS Child)

    Time frame: Day 1

    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.

  2. The Tampa Scale 17 (TSK-17)

    Time frame: Day 1

    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.

  3. Duration of pain

    Time frame: Day 1

    Participants self-reported duration of pain denoted in months

  4. Worst pain in the last week

    Time frame: Day 1

    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.

  5. Worst pain in the last 24 hours

    Time frame: Day 1

    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.

  6. Current pain

    Time frame: Day 1

    The participants current pain on the Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.

  7. Counter Movement Jump Test

    Time frame: Day 1

    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.

  8. Counter Movement Jump Test

    Time frame: Day 1

    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.

  9. Pain during Counter Movement Jump Test

    Time frame: Day 1

    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.

  10. Anterior Knee Pain Provocation test

    Time frame: Day 1

    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.

  11. Level of sports- participation and performance compared to before knee pain

    Time frame: Day 1

    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

  12. Level of physical activity compared to before knee pain

    Time frame: Day 1

    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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Rate of Torque Development in Adolescents With Osgood-Schlatter: A Cross-sectional Case-control Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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