Getting Kids With Osgood Schlatter Back to Performing Without Pain

NCT ID: NCT05826340

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2024-12-31

Brief Summary

The goal of this trial is to compare graded return to sport, or pain guided activity to rest in youth with Osgood Schlatter. The main objectives are:

• to assess the graded return to sport, or pain guided activity on symptoms (pain and function) at six months compared to rest

The secondary objectives are to assess the impact of progressive return to sport or pain guided activity on:

• Muscle strength and performance
• Anterior knee pain provocation
• Sports participation
• Physical activity

The exploratory objectives are to assess the impact of progressive return to sport on ultrasound imaging characteristics of OSD.

Detailed Description

Osgood Schlatter disease (OSD) affects 10% of adolescents aged 9-15. This makes it the most common knee pain condition in this age group. OSD is considered an overuse injury, common in highly sports active adolescents. It is considered an apophyseal injury of the tibial tuberosity, the site of attachment of the patellar tendon onto the tibia. Repetitive forces exerted on tissues without allowing for recovery can cause pain and/or tissue damage at the site of attachment onto the weak developing apophyseal cartilage which is thought to be a susceptible injury before the apophysis is fully matured. Characteristics such as cartilage swelling, and associated tendon changes (including thickening of the patellar tendon and increased doppler activity) have been documented.

Despite narrative reviews recommending conservative management, there is a complete lack of clinical research evaluating the different recommendations, which range from passive interventions, such as rest/activity limitation, to more active approaches including strength exercises for the lower extremity. We have developed a new progressive return to sport intervention approach which has been piloted in adolescents with OSD. The targeted intervention aims to balance recovery, and graded loading in a guided return to sport paradigm The goal is to help support adolescents manage pain, and guide return to sport & function.

There is a need to test other potential conservative interventions which have yet to be examined in a randomised manner. Multi-arm trials allow more treatments to be assessed than a standard two arm trial. This makes this design simpler, quicker and cheaper than running multiple two arm trials, which will produce contemporaneous results for all treatments. This is relevant in the context of OSD, where none of the conservative recommendations have been evaluated. Despite rest being advocated, it may be possible to allow adolescents to participants to participate in sports to the extent that pain allows (pain guided activity). This may be beneficial, given the social and health consequences of complete withdrawal from sport. We therefore aim to evaluate both the progressive return to sport paradigm and pain guided activity in a 3-armed randomised trial, compared to advice to rest and withdrawal from sports.

Conditions

Osgood-Schlatter Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tailored loading

Participants will be provided with a 5-stage return to sport tool, which gradually increases sports intensity and knee loading. In addition, they are to perform a progressive exercise program at home to increase lower extremity strength and prepare them for the demands of sport. Participants will begin at a starting point in the five stages based on their current symptoms and self reported sports related disability, and given guidance on how to progress / regress their loading within the five stage framework

Group Type: EXPERIMENTAL

Tailored progressive loading and return to sport

Intervention Type: BEHAVIORAL

Participants will undergo a 5-stage progressive return to sport tool.

Pain within acitvity limits

Participants will be advised to participate in sport/exercise to the extent that pain allows. They will not be restriced full from sport but will be instructed how to use a pain moritoring tool to help monitor pain and balance the amount of activities in which they can participate.

Group Type: EXPERIMENTAL

Pain guided activity

Intervention Type: BEHAVIORAL

Participants will be provided on information on how to guide activity based on pain response.

Rest until pain subsides

Participants will be provided advice on rest for a minimum of four weeks or until pain subsides

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tailored progressive loading and return to sport

Participants will undergo a 5-stage progressive return to sport tool.

Intervention Type: BEHAVIORAL

Pain guided activity

Participants will be provided on information on how to guide activity based on pain response.

Intervention Type: BEHAVIORAL

Other Intervention Names

Progressive return to sport

Eligibility Criteria

Inclusion Criteria

• Children/adolescents (male and female) aged 8-16 years

• Diagnosis of OSD based on clinical examination including localised pain at the tibial tuberosity (the insertion of the patellar tendon onto the shin) that increases by palpation, and pain during resisted isometric knee extension.
• Ability to understand and the willingness to provide consent

Exclusion Criteria

• Any other diagnosable knee pathology, patellar instability, and patellofemoral instability.
• Previous knee surgery
• Habitual patella subluxation
• Clinical suspicion of meniscal lesion
• Previous neurologic, musculoskeletal or mental illnesses
• Other chronic conditions that may affect the involved musculoloskeletal/connective tissues and treatment (autoimmune, metabolic disorders, diabetes, etc.)
• Lack of ability to cooperate

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Sinead Holden

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sinead Holden, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Michael S Rathleff, Dr. Med

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Jens Olesen

Role: PRINCIPAL_INVESTIGATOR

Centre for Almen Medicin ved Aalborg Universitet

Locations

Research Unit for General Practice in Aalborg

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Michael S Rathleff, DrMed

Role: CONTACT

quickreturnOSD@hst.aau.dk

Facility Contacts

Sinead Holden

Role: primary

quickreturnHST@aau.dk

Other Identifiers

N-20210052

Identifier Type: OTHER

Identifier Source: secondary_id

Quick Return OSD 001

Identifier Type: -

Identifier Source: org_study_id