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Completed

NCT Number: NCT05174182

A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter

The most common growth-related injury is Osgood Schlatter, which affects up to 1 in 5 physically active adolescents. It can cause long-term pain and potential discontinuation of sports and physical activity, with sequela well into adulthood. No effective conservative treatments have been documented, and clinical practice is characterized by a wealth of conflicting advice and modalities. A novel treatment approach has shown promising results in a small single-cohort study. Therefore, this study aims to compare this novel treatment with usual care in 10-16-year-old adolescents with Osgood Schlatter.

This single-center pragmatic, double-blinded, randomized, controlled superiority trial, will have a two-group parallel arm design. Participants will undergo 3 months of treatment, followed by 2 months of self-management with self-reported knee function (KOOS-child 'Sport/rec') at 5 months as the primary endpoint.

This trial comparing a novel treatment with usual care for adolescents with Osgood Schlatter could result in an evidence-based treatment ready for implementation in clinical practice, benefitting patients outcomes and clinicians.

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital

Hvidovre, 2610, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Tenderness on palpation of the tibial tuberosity or pain during resisted isometric knee extensions
  • Insidious onset of pain or swelling of the tibial tuberosity for ≥6 weeks
  • Provoked by at least 2 of the following positions or activities; prolonged sitting or kneeling, squatting, running, hopping/jumping, stair walking or during multidirectional sports
  • Clinical diagnosis of Osgood Schlatter
  • Markedly reduced sports participation OR severely affected by pain during sports participation

Exclusion criteria

  • Other primary pathology or complaints from other structures of the knee
  • Other injuries, complaints or illnesses that may cause disability, or specifically restricts levels of physical activity or sports participation
  • Previous surgery in the lower extremities or lumbar spine
  • Congenital deformities, device implants og cysts og tumors of the knee
  • Participants not willing to cease concomitant treatment
  • Participants and their parents not able to understand and communicate in written and verbal Danish

Treatment and study plan

A novel treatment approach

Other

A novel treatment approach, as described before.

Usual Care

Other

Usual care, as described before.

Primary outcomes

  1. Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline

    Time frame: 5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)

    The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.

Secondary outcomes

  1. Patient Acceptable Symptom State change from baseline

    Time frame: 5 months

    The question pertaining to Patient Acceptable Symptom State (PASS) are designed in collaboration with patient representatives. The recall period will be one week, and the outlook period a 'few months' as in previous applications in musculoskeletal conditions with fluctuating symptoms:

    "If you consider your knee pain during the past week, and how it affects your ability to do activities of daily living (for example participating in school, in sports, and socially), would you consider your current symptom state acceptable for the next few months?". The proportions of yes/no in each group will be captured

  2. Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline

    Time frame: 5 months

    The scale contains 6 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.

  3. Frequency of Pain Flares

    Time frame: 5 months

    Weekly average of pain flares over a 4-week period leading up to the 5 months visit. Pain flares are defined as episodes of of 4 or more on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.

  4. Pain Flare Intensity change from baseline

    Time frame: 5 months

    Pain intensity as defined as the highest rating of pain on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.

  5. Hours of Sports Participation

    Time frame: 5 months

    The level of participation in sports will be captured through weekly monitoring. Participants will be asked if they have been participating in sports in the preceding week, and for how many hours. A 4-week average leading up to the 5 month visit will be calculated

  6. Hours of Physical Activity

    Time frame: 5 months

    Minutes of Moderate to Vigorous Physical Activity (MVPA) will be captured using waterproof 3 axis 12 Hz accelerometers (SENS®, Copenhagen, Denmark) applied once to the participants thigh during the enrollment visit using an adhesive patch. A 4-week average leading up to the 5 month visit will be calculated

    According to WHO recommendations a daily minimum of 60 min of MVPA is needed to stay healthy for 5-17 year olds.Thus being at either under or above this cutoff during a 4-week average leading up to the 5 month visit will be assessed, in addition to a continuous comparison between the two groups of minutes of MVPA during the same time period.

  7. Satisfaction with extent of sports participation change from baseline

    Time frame: 5 months

    Participants will also be asked during clinical visits if they are satisfied with the current extent of their sports participation (Yes/No questions).

  8. Tendinosis signs change from baseline

    Time frame: 5 months

    Involvement of the tendon is common in patients with Osgood Schlatter. Signs of tendinosis will be assess through ultrasound scanning by evaluating either the tendon as thickened or with hyperemia through color-doppler mode.

  9. Infrapatellar bursitis signs change from baseline

    Time frame: 5 months

    In Osgood-Schlatter patients, associated signs of bursitis have shown to be prognostic of a worse outcome. Signs of tendinosis will be assess through ultrasound scanning by evaluating either the infrapatellar bursa as thickened or with hyperemia through color-doppler mode.

  10. Flaviis composite severity score change from baseline

    Time frame: 5 months

    In Osgood-Schlatter patients, gradings of severity have shown to be prognostic of a worse outcome. Severity will be graded according to the ad modum Flaviis 1-4 grading, or as 'normal'.

  11. Anterior Knee Pain Provocation test change from baseline

    Time frame: 5 months

    Adolescents will rate their pain from performing the Anterior Knee Pain Provocation test on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.

  12. Pain during knee extension strength test change from baseline

    Time frame: 5 months

    Adolescents will rate pain experienced during a maximal isometric knee extension strength test on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.

  13. Pressure-pain threshold at the tibial tubercle change from baseline

    Time frame: 5 months

    To evaluate local hyperalgesia specifically at the tibial tubercle, handheld algometry will be used to detect the pressure (kPa) needed to evoke pain (going from no pain to the slightest sensation of pain) on the tibial tubercle on both knees

  14. Maximal isometric knee extension strength change from baseline

    Time frame: 5 months

    To evaluate the capacity of the quadriceps femoris muscle inserting at the site of pain, handheld dynamometry will be used to measure maximal isometric force generation which will be normalized to bodyweight and lever-length (Nm/kg).

  15. Countermovement jump height change from baseline

    Time frame: 5 months

    As a measure of sports-specific skill, a countermovement jump will be performed to record jump height (cm), using high-speed video analysis via a smartphone app (My Jump 2).

  16. Global rating of Change

    Time frame: 5 months

    To assess patient-assessed improvement or worsening, study personnel will ask participants to rate their perceived level of change from their first visit on a 7-point likert scale ranging from 'Much worse' to 'Much better'.

  17. Patient-specific function scale change from baseline

    Time frame: 5 months

    Study personnel will ask participants to rate their problems with an important activity using the Patient-Specific Functional Scale. They are asked to name a single important activity of their own choosing. Participants then rate their functional limitation with activity on a 0 to 10 scale, where 0 corresponds to being unable to perform activity and 10 is being able to perform activity at same level as before knee pain.

  18. Kinesiophobia change from baseline

    Time frame: 5 months

    To capture level of kinesiophobia, that is, the fear of pain due to movement or exercise, a type of fear-avoidance behavior, the patient-reported 17-item Tampa Scala of Kinesiophobia (TSK-17) will be used.

  19. Self-rated health change from baseline

    Time frame: 5 months

    Self-rated health will be collected through the 0-100 VAS for general health.

Other outcomes

  1. Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Pain' Subscale change from baseline

    Time frame: 5 months

    The scale contains 8 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.

  2. Level of pain/discomfort change from baseline

    Time frame: 5 months

    Using the EQ-D5-Y scale, participants are asked on a 3-point likert scale ranging from 1 (I have no pain or discomfort), to 3 (I have extreme pain or discomfort).

  3. Level of sports participation compared to before knee pain

    Time frame: 5 months

    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

  4. Level of physical activity compared to before knee pain

    Time frame: 5 months

    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

  5. Time to return to sport

    Time frame: 5 months

    For the subgroup of participants not being active in sports at baseline, the week in which they return to sports participation will be recorded and compared between groups.

  6. Hyperemia of the tibial tubercle change from baseline

    Time frame: 5 months

    Hyperemia of the tibial tubercle will be assess through ultrasound scanning by evaluating hyperemia ad modum Öhberg 1-4 through color-doppler mode.

  7. Palpation pain of the tibial tubecle

    Time frame: 5 months

    Known pain when palpating the tibial tubecle during clinical examination change from baseline

  8. Pain during Countermovement Jump Test change from baseline

    Time frame: 5 months

    Adolescents will rate pain experienced during the CMJ test on the NPRS 0-10.

  9. Countermovement jump power change from baseline

    Time frame: 5 months

    As a measure of power, a countermovement jump will be performed to record jump and power-production (watts), using high-speed video analysis via a smartphone app (My Jump 2).

  10. Knee extensor flexibility change from baseline

    Time frame: 5 months

    Between-group change in knee flexion angle, assessed by smartphone-inclinometry during a modified Thomas Test will be compared.

  11. Satisfaction with treatment

    Time frame: 5 months

    Participants are asked if they believe the treatment recieved have been succesful or not (Yes/No question)

  12. Problems with usual activities change from baseline

    Time frame: 5 months

    Using the EQ-D5-Y scale, participants are asked on a 3-point likert scale ranging from 1 (I have no problems performing my usual activities), to 3 (I am unable to perform my usual activities).

  13. Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Symptoms' change from baseline

    Time frame: 5 months

    The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.

  14. Harms and adverse events

    Time frame: 5 months

    Potential harms and adverse events will be assesed through open-ended questioning during clinical visits in order to assess if further examination or treatment is warranted, and to classify events according to the severity on from Grade 1-5 Using the Common Terminology Criteria for Adverse Events (CTCAE) grading:

    • Mild: Asymptomatic or minor symptoms; clinical or diagnostic observations only; no intervention needed
    • Moderate: Minimal, local, or non-invasive intervention indicated
    • Severe: Medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling
    • Life-threatening consequences (i.e., immediate risk of death); urgent intervention indicated
    • Death related to adverse event

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Aalborg University
  • University College Copenhagen

Registry information

Official study title

A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)

Acronym: SOGOOD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2021
Registry last updated
Apr 11, 2025

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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