An interventional study of Tailored progressive loading and return to sport and Pain guided activity in Osgood-Schlatter Disease, sponsored by Aalborg University. Status unknown at 1 site in Denmark. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by Aalborg University · Not applicable, Interventional, and Treatment
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:
The secondary objectives are to assess the impact of progressive return to sport or pain guided activity on:
The exploratory objectives are to assess the impact of progressive return to sport on ultrasound imaging characteristics of OSD.
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.
16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.
This study's planned enrollment of 144 is above the median of 51 across 13 interventional studies indexed under Osteochondrosis.
Browse Osteochondrosis studies →Aalborg University is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participants will be provided advice on rest for a minimum of four weeks or until pain subsides
Participants will undergo a 5-stage progressive return to sport tool.
Also known as: Progressive return to sport
Participants will be provided on information on how to guide activity based on pain response.
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.
Time frame: 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
Time frame: 6 months
Health related quality of life
Health related quality of life will be measured by the youth version of the European Quality of Life 5 Dimensions (EQ-5D-Y) at baseline, 3months, 6 months and 12months. The index score ranges from 0-1, with 1 indicating full health.
Time frame: 3 months, 6 months, 12 months
Muscle strength and performance
Isometric knee extension torque, hip abduction, and hip extension torque will be measured using a handheld dynamometer. Participants will perform three maximal effort contractions. Results will be averaged and normalised to body weight and lever length. Lower limb power will be conducted by asking the participants to perform single leg vertical and horizontal jumps.
Time frame: 6 months
Sports participation
Adolescents will report their weekly sports volume (expressed in hours per week).
Time frame: 3months, 6months, 12 months
Return to sport
In case of any absence from sport, the time to return to sport (i.e. duration of absence) will be documented.
Time frame: 3months, 6months, 12 months
Objective physical activity
Participants will be provided with an Actigraph monitor for two weeks to objectively measure physical activity (time spent in moderate to vigorous physical activity and sedentary time at 6 months follow-up. The specific model used will be the wGT3X- BT actigraphy device (ActiGraphCorp, Pensacola, FL), which is a compact, wrist- worn, battery-powered, CE marked device that captures and records continuous, high resolution physical activity and sleep/wake information.
Time frame: 6 months
Pain severity during palpation
Numeric rating scale ranging from 0, no pain to 10 worst imaginable pain) in response to palpation of the tibial tuberosity.
Time frame: 6 months
Pain severity during knee loading
Numeric rating scale ranging from 0, no pain to 10 worst imaginable pain) in response to the anterior knee pain provocation (AKPP). Participants will be asked to complete a single leg squat to about 60 degrees of knee flexion and hold the position for 30 seconds. Pain will be recorded at the end of 30 seconds.
Time frame: 6 months
Global rating of change
Self-reported recovery on a 7-point Likert scale, ranging from much better, to much worse.
Time frame: 3 months, 6 months, 12 months
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.
Time frame: 3 months, 12 months
Sports related function
The patient reported questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS)\[22\] contains five separate subscales. We will use the KOOS-Child Sport/Rec subscale to assess sports related function. This scale ranges from 0-100 with higher scores reflecting better outcomes
Time frame: 3 months, 12 months
OSD ultrasound staging according to DeFlaviis
Ultrasound scans of the knee will be used at baseline and six months to evaluate OSD ultrasound classification according to DeFlaviis (no changes, cartilage swelling, cartilage swelling plus bony changes, associated bursitis, associated tendonopathy).
Time frame: 6 months
Ulstrasound characteristics: neovascularisation
Ultrasound scans of the knee will be used at baseline and six months to evaluate neovascularisation in the tendon and apophysis. This will be done by evaluating the presence of positive Doppler signal.
Time frame: 6 months
Ulstrasound characteristics: tendon thickness
Ultrasound scans of the knee will be used at baseline and six months to evaluate tendon thickness at the distal patellar tendon. To determine distal thickness, a transversal scan taken 1cm from TT attachment will be used.
Time frame: 6 months
Patient satisfaction
Patient satisfaction with the results of the treatment will be asked on a 5-point Likert scale ranging from very satisfied to very unsatisfied.
Time frame: 3months ,6 months, 12 months
Plan to share: Yes — Data will be managed according to the FAIR principles (findable, accessible, inter-operable and reproducible). Meta-data will be uploaded to Open Science framework with restrictions and terms for accessing the anonymised data according for research purposes, where appropriate.
Supporting information: Study protocol
Time frame: Anticipated after study completion and publication
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Apr 2024, 15 months after the start.
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