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

NCT07430072 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Spondylolysis Lumbar

Interventions

OTHER

Active 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 & Collaborators

  • Haukeland University Hospital

    collaborator OTHER
  • Nottingham Trent University

    collaborator OTHER
  • Federation Internationale de Football Association

    collaborator OTHER
  • Western Norway University of Applied Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430072 on ClinicalTrials.gov