Rate of Torque Development in Adolescents With Osgood-Schlatter

Osgood-Schlatter Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789095
• Other study ID #: H-20072873
• Status: Completed
• Start date: February 28, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Osgood-Schlatter Disease

Intervention

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)
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.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Day 1
Other	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.	Day 1
Other	Duration of pain	Participants self-reported duration of pain denoted in months	Day 1
Other	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.	Day 1
Other	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.	Day 1
Other	Current pain	The participants current pain on the Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.	Day 1
Other	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.	Day 1
Other	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.	Day 1
Other	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.	Day 1
Other	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.	Day 1
Other	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	Day 1
Other	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	Day 1
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pain during strength testing (NRS 10)	Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.	Day 1