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

Osgood-Schlatter Disease Clinical Trial

— SOGOOD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05174182
• Other study ID #: H-21028912
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: March 10, 2028

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: March 10, 2028
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Apophysitis
• Osgood-Schlatter Disease

Intervention

Other:
• A novel treatment approach
A novel treatment approach, as described before.
• Usual care
Usual care, as described before.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Aalborg University, University College Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Pain' Subscale change from baseline	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.	5 months
Other	Level of pain/discomfort change from baseline	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).	5 months
Other	Level of sports participation 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	5 months
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	5 months
Other	Time to return to sport	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.	5 months
Other	Hyperemia of the tibial tubercle change from baseline	Hyperemia of the tibial tubercle will be assess through ultrasound scanning by evaluating hyperemia ad modum Öhberg 1-4 through color-doppler mode.	5 months
Other	Palpation pain of the tibial tubecle	Known pain when palpating the tibial tubecle during clinical examination change from baseline	5 months
Other	Pain during Countermovement Jump Test change from baseline	Adolescents will rate pain experienced during the CMJ test on the NPRS 0-10.	5 months
Other	Countermovement jump power change from baseline	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).	5 months
Other	Knee extensor flexibility change from baseline	Between-group change in knee flexion angle, assessed by smartphone-inclinometry during a modified Thomas Test will be compared.	5 months
Other	Satisfaction with treatment	Participants are asked if they believe the treatment recieved have been succesful or not (Yes/No question)	5 months
Other	Problems with usual activities change from baseline	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).	5 months
Other	Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Symptoms' change from baseline	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.	5 months
Other	Harms and adverse events	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	5 months
Primary	Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline	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.	5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)
Secondary	Patient Acceptable Symptom State change from baseline	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	5 months
Secondary	Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline	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.	5 months
Secondary	Frequency of Pain Flares	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.	5 months
Secondary	Pain Flare Intensity change from baseline	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 months
Secondary	Hours of Sports Participation	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	5 months
Secondary	Hours of Physical Activity	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.	5 months
Secondary	Satisfaction with extent of sports participation change from baseline	Participants will also be asked during clinical visits if they are satisfied with the current extent of their sports participation (Yes/No questions).	5 months
Secondary	Tendinosis signs change from baseline	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.	5 months
Secondary	Infrapatellar bursitis signs change from baseline	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.	5 months
Secondary	Flaviis composite severity score change from baseline	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'.	5 months
Secondary	Anterior Knee Pain Provocation test change from baseline	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.	5 months
Secondary	Pain during knee extension strength test change from baseline	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.	5 months
Secondary	Pressure-pain threshold at the tibial tubercle change from baseline	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	5 months
Secondary	Maximal isometric knee extension strength change from baseline	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).	5 months
Secondary	Countermovement jump height change from baseline	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).	5 months
Secondary	Global rating of Change	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'.	5 months
Secondary	Patient-specific function scale change from baseline	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.	5 months
Secondary	Kinesiophobia change from baseline	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.	5 months
Secondary	Self-rated health change from baseline	Self-rated health will be collected through the 0-100 VAS for general health.	5 months