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

NCT07430072 | Not Yet Recruiting DMC

• 1 other identifier: 821259
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Spondylolysis Lumbar

Keywords

Spondylolysis; adolescent; MRI; football

Outcome Measures

Primary Outcomes (1)

• Change in edema on MRI

  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

  Baseline, 3 months and potentially at 6 months.

Secondary Outcomes (2)

• Changes in Youth Back Activity Questionnaire - norwegian version

  Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks

• Changes in Oswestry Disability Index

  Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks

Study Arms (1)

Active rehabilitation of low grade lumbar spondylolysis

EXPERIMENTAL

Other: Active rehabilitation protocol

Interventions

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.

Also known as: ActiveBack, AktivRygg

Active rehabilitation of low grade lumbar spondylolysis

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Norway University of Applied Sciences: lead
• Haukeland University Hospital: collaborator
• Nottingham Trent University: collaborator
• Federation Internationale de Football Association: collaborator

Study Sites (3)

Idrettsmedisinsk Klinikk, Brann Stadion

Bergen, 5052, Norway

Location

Western Norway Center for Sports Medicine

Bergen, 5058, Norway

Location

The Norwegian FA Sports Medicine Clinic

Oslo, 1177, Norway

Location

Related Publications (18)

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Related Links

• Link to site with current and past reseach projects

MeSH Terms

Conditions

Spondylolysis

Condition Hierarchy (Ancestors)

Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Bård E Bogen, Professor

CONTACT

+4791157142; bard.e.bogen@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From project end, approx. 2027 and five years onward.
• Access Criteria: Anyone will be able to request the data provided by the researchers upon request via e-mail.

Locations

NO (3)