Rate of Torque Development in Adolescents With Osgood-Schlatter

NCT05789095 | Completed

• 1 other identifier: H-20072873
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Osgood-Schlatter Disease

Keywords

Adolescents; Rate of torque development; Osgood-Schlatter; Neuromuscular; Inhibition

Outcome Measures

Primary Outcomes (7)

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

Secondary Outcomes (1)

• Pain during strength testing (NRS 10)

  Day 1

Other Outcomes (12)

• Knee osteoarthritis Outcome Score for children (KOOS Child)

  Day 1

• The Tampa Scale 17 (TSK-17)

  Day 1

• Duration of pain

  Day 1

Study Arms (2)

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

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.

Case-group; Control-group

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2610, Denmark

Location

MeSH Terms

Conditions

Osteochondrosis; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sensior Research Coordinator, PhD Fellow

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 29, 2023
• Study Start: February 28, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

DK (1)