Getting Kids With Osgood Schlatter Back to Performing Without Pain

NCT05826340 | Unknown

• 2 other identifiers: Quick Return OSD 001N-20210052
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Osgood-Schlatter Disease

Keywords

Growth; Adolescent; Musculoskeletal; Pain; Osteochondrosis

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity will be captured using a visual analogue scale (VAS) ranging from 0cm (no pain) to 10cm (worst pain imaginable) where participants are asked to rate their worth pain in the previous week.

  6 months

• Sports related function

  The patient reported questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS) contains five separate subscales. We will use the KOOS-Child Sport/Rec subscale to assess sports related function.The scale ranges from 0-100, with higher scores indicating better outcomes

  6 months

Secondary Outcomes (10)

• Health related quality of life

  3 months, 6 months, 12 months

• Muscle strength and performance

  6 months

• Sports participation

  3months, 6months, 12 months

• Return to sport

  3months, 6months, 12 months

• Objective physical activity

  6 months

Other Outcomes (4)

• OSD ultrasound staging according to DeFlaviis

  6 months

• Ulstrasound characteristics: neovascularisation

  6 months

• Ulstrasound characteristics: tendon thickness

  6 months

Study Arms (3)

Tailored loading

EXPERIMENTAL

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

Behavioral: Tailored progressive loading and return to sport

Pain within acitvity limits

EXPERIMENTAL

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.

Behavioral: Pain guided activity

Rest until pain subsides

NO INTERVENTION

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

Interventions

Tailored progressive loading and return to sport BEHAVIORAL

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

Also known as: Progressive return to sport

Tailored loading

Pain guided activity BEHAVIORAL

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

Pain within acitvity limits

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Research Unit for General Practice in Aalborg

Aalborg, 9220, Denmark

RECRUITING

MeSH Terms

Conditions

Osteochondrosis; Pain

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sinead Holden, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

• Michael S Rathleff, Dr. Med

  Aalborg University

  PRINCIPAL INVESTIGATOR

• Jens Olesen

  Centre for Almen Medicin ved Aalborg Universitet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael S Rathleff, DrMed

CONTACT

quickreturnOSD@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: April 24, 2023
• Study Start: January 26, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anticipated after study completion and publication

Locations

DK (1)