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ClinicalTrials.gov ID

NCT07430072

Lead Sponsor

Western Norway University of Applied SciencesOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

May 6, 2026Actual

Start Date

May 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Feb 2027Estimated

Official Title

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

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.

• Spondylolysis Lumbar

• Active rehabilitation protocol

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Western Norway University of Applied SciencesOTHER

Collaborators

Haukeland University HospitalOTHER

Nottingham Trent UniversityOTHER

Federation Internationale de Football AssociationOTHER

nicolay.morland@gmail.com+4798654380

jan.loken@ihs.no+4791601122