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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07430072
Acronym
ActiveBack
Enrollment
40
Registered
2026-02-24
Start date
2026-05-01
Completion date
2027-02-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylolysis Lumbar

Keywords

Spondylolysis, adolescent, MRI, football

Brief summary

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.

Interventions

OTHERActive rehabilitation protocol

Current Norwegian guidelines recommend that everyone with this injury stop participating in sports for a minimum of 3 months. There is very little research supporting these, and other international, guidelines. Considering the negative consequences of the current regime, we wish to conduct a pilot project with 30-40 football (soccer) players aged 13-19 with the mildest, and most common, MRI grading of this injury (Grade 1). Here, we aim to test a rehabilitation protocol that is more pain-controlled and individually adapted to each athlete. The training protocol is based on other so-called low-risk stress fractures, where the probability of healing is considered good, and is divided into four phases. The time it takes to complete the rehabilitation protocol will be quite similar to the expected healing time and current protocols. The actual rehabilitation time may ultimately end up being both shorter and longer than current protocols, but with a higher degree of meaningful activity.

Sponsors

Western Norway University of Applied Sciences
Lead SponsorOTHER
Haukeland University Hospital
CollaboratorOTHER
Nottingham Trent University
CollaboratorOTHER
Federation Internationale de Football Association
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in edema on MRIBaseline, 3 months and potentially at 6 months.Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis. An addiotonal MR will be performed at 6 months for patients with the same or higher classification on the Hollenberg Critera at the 3 month follow-up

Secondary

MeasureTime frameDescription
Changes in Youth Back Activity Questionnaire - norwegian versionBaseline, 6 weeks, 12 weeks, 18 weeks and 26 weeksThe Youth Back Activity Questionnaire (YouthBAQ) is a 14-item validated tool designed specifically to measure functional limitations in adolescents (12-18) with low back pain. YouthBAQ is scored on 0-100 scale with 100 representing no disability and 0 representing maximum disability.
Changes in Oswestry Disability IndexBaseline, 6 weeks, 12 weeks, 18 weeks and 26 weeksThe Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. It is considered one of the best accepted tools for assessment of low back pain, but it is not designed for adolescents.

Countries

Norway

Contacts

CONTACTBård E Bogen, Professor
bard.e.bogen@uib.no+4791157142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026