ClinicalTrials.gg
CompletedNCT05789095Updated Jan 9, 2024

Rate of Torque Development in Adolescents With Osgood-Schlatter

An observational study in Osgood-Schlatter Disease, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 9 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Hvidovre University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
26
Ages
9 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osgood-Schlatter Disease

Browse trials for

Keywords

  • Adolescents
  • Rate of torque development
  • Osgood-Schlatter
  • Neuromuscular
  • Inhibition
03

In context

Osteochondrosis

16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.

Browse Osteochondrosis studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • Case-group

    13 adolescents, 9-16 years, with Osgood-Schlatter Disease.

    Other: 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)

  • Control-group

    13 healthy adolescents, 9-16 years, without any knee pain, matched on age, sex and type of sport on the group-level.

    Other: 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)

Interventions

  • OtherRate 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)

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

Secondary outcomes

  1. Pain during strength testing (NRS 10)

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

    Time frame: Day 1

Other outcomes

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

    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.

    Time frame: Day 1

  2. The Tampa Scale 17 (TSK-17)

    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.

    Time frame: Day 1

  3. Duration of pain

    Participants self-reported duration of pain denoted in months

    Time frame: Day 1

  4. Worst pain in the last week

    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.

    Time frame: Day 1

  5. Worst pain in the last 24 hours

    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.

    Time frame: Day 1

  6. Current pain

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

    Time frame: Day 1

  7. Counter Movement Jump Test

    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.

    Time frame: Day 1

  8. Counter Movement Jump Test

    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.

    Time frame: Day 1

  9. Pain during Counter Movement Jump Test

    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.

    Time frame: Day 1

  10. Anterior Knee Pain Provocation test

    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.

    Time frame: Day 1

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

    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

    Time frame: Day 1

  12. Level of physical activity compared to before knee pain

    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

    Time frame: Day 1

07

Study locations

1 site
  • Hvidovre Hospital
    Hvidovre, 2610, Denmark
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The dataset will be published either along the primary peer-reviewed journal publication if this will be available, otherwise to a public repository with a permanent Digital Object Identifier (DOI), for example, zenodo, figshare or similar.

Supporting information: Study protocol

Time frame: The study protocol wil be uploaded to this registration once the study has been given an identifier from ClinicalTrials.gov

Access criteria: No restrictions, but collaborators are required to adhere to the CC-BY-NC-ND 4.0 Licensing: Anyone can share this material, provided it remains unaltered in any way, this is not done for commercial purposes, and the original authors are credited and cited.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05789095
Responsible party
Kasper Krommes (Sensior Research Coordinator, PhD Fellow, Hvidovre University Hospital) — Principal investigator
First posted
Mar 29, 2023
Start date
Feb 28, 2023
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Jan 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion