A Pilot Study on the Safety of Active Conservative Management of Low Grade Lumbar Stress Reactions in Adolescent Soccer Players

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorWestern Norway University of Applied Sciences

About this trial

Introduction: The Background

* Prevalence: Low back pain (LBP) is very common in young athletes, and lumbar spondylolysis (an overuse injury of bones in the low back) is the leading cause. In adolescent male soccer players with LBP, almost half (up to 48%) have this specific injury. * The Current Standard: Existing Norwegian guidelines mandate a break from all sports for a minimum of 3 months when rehabilitating spondylolysis * The Challenge: These strict guidelines lack strong evidence from clinical trials and can lead to negative social and physical consequences for the athlete, including exclusion from team activities and reduced general physical activity.

AIM: The Goal of the Study To determine the safety and effectiveness of a newly developed, 4-phased, pain-controlled rehabilitation protocol that uses early, criteria-based activity progression (based on functional capacity and pain levels) for youth football players diagnosed with spondylolysis.

Method: Study Design and Measurements

* Design: This is a pilot study (prospective cohort study) involving 30-40 youth football players with a first-time diagnosis of low grade (1-2) spondylolysis. * Diagnosis: The injury is confirmed using an MRI scan (specifically the VIBE sequence). * Data Collection: We will gather data through:

* MRIs: Comparing images at baseline (start) and after 3 months. * Standardized Clinical Examinations. * PROMs (Patient-Reported Outcome Measures - standardized questionnaires about function and pain). * Weekly reporting on pain intensity and training volume. * Outcome: We will compare the changes in the bone healing seen on the MRI findings between the start and end of the 3-month period, and at six months if applicable.

Eligibility criteria

Qualifiers

Age: 14-19.

Soccer players

Low grade (1-2) lumbar stress reaction in L4 or L5.

Pain in the area of the affected vertebrae with sports activity and/or ADL.

Disqualifiers

Not able to get MRI,

Other conditions/injuries that potentially could affect the result (at baseline and during follow up), i.e. lumbar disc prolapse, scheurmans disease, ankylosing spondylitis,

Disorders influencing growth.

Previously unsuccessful treatment of lumbar stress reaction.

Trial design

Treatments tested in this trial

  • Active rehabilitation protocol

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Western Norway University of Applied Sciences

Lead sponsor

Haukeland University Hospital

Collaborator

Nottingham Trent University

Collaborator

Federation Internationale de Football Association

Collaborator