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NCT Number: NCT07430072

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

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.

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Key information

Conditions

Spondylolysis Lumbar Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylolysis Spondylosis

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Idrettsmedisinsk Klinikk, Brann Stadion, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active rehabilitation protocol

Other

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.

Other names: ActiveBack, AktivRygg

Primary outcomes

  1. Change in edema on MRI

    Time frame: Baseline, 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 outcomes

  1. Changes in Youth Back Activity Questionnaire - norwegian version

    Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks

    The 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.

  2. Changes in Oswestry Disability Index

    Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bård E Bogen, Professor

CONTACT

[email protected]

+4791157142

Sponsors and collaborators

Lead sponsor

Western Norway University of Applied Sciences

Other

Collaborators

  • Federation Internationale de Football Association
  • Haukeland University Hospital
  • Nottingham Trent University

Registry information

Acronym: ActiveBack

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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