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

Overview

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

• 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-control

Primary outcome measures

• Change in edema on MRI [Time frame: Baseline, 3 months and potentially at 6 months.]

Secondary outcome measures (2)

• Changes in Youth Back Activity Questionnaire - norwegian version [Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks]
• Changes in Oswestry Disability Index [Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Norway · 3 centers

• Idrettsmedisinsk Klinikk, Brann Stadion — Bergen
• Western Norway Center for Sports Medicine — Bergen
• The Norwegian FA Sports Medicine Clinic — Oslo

Publications

• Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016 Dec;50(23):1428-1437. doi: 10.1136/bjsports-2016-096651. Epub 2016 Oct 5. PMID 27707738
• Dalen-Lorentsen T, Ranvik A, Bjorneboe J, Clarsen B, Andersen TE. Facilitators and barriers for implementation of a load management intervention in football. BMJ Open Sport Exerc Med. 2021 Jun 22;7(2):e001046. doi: 10.1136/bmjsem-2021-001046. eCollection 2021. PMID 34249374
• Grotle M, Brox JI, Vollestad NK. Cross-cultural adaptation of the Norwegian versions of the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. J Rehabil Med. 2003 Sep;35(5):241-7. doi: 10.1080/16501970306094. PMID 14582557
• Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29. PMID 15928561
• Koh E, Walton ER, Watson P. VIBE MRI: an alternative to CT in the imaging of sports-related osseous pathology? Br J Radiol. 2018 Jul;91(1088):20170815. doi: 10.1259/bjr.20170815. Epub 2018 Mar 15. PMID 29474097
• Dhouib A, Tabard-Fougere A, Hanquinet S, Dayer R. Diagnostic accuracy of MR imaging for direct visualization of lumbar pars defect in children and young adults: a systematic review and meta-analysis. Eur Spine J. 2018 May;27(5):1058-1066. doi: 10.1007/s00586-017-5305-2. Epub 2017 Sep 23. PMID 28942567
• Takei S, Torii S, Taketomi S, Iwanuma S, Tojima M, Otomo M, Iizuka S, Tanaka S. Is Increased Kicking Leg Iliopsoas Muscle Tightness a Predictive Factor for Developing Spondylolysis in Adolescent Male Soccer Players? Clin J Sport Med. 2022 Mar 1;32(2):e165-e171. doi: 10.1097/JSM.0000000000000920. PMID 33844489
• Tsutsui T, Iizuka S, Takei S, Maemichi T, Torii S. Risk Factors for Symptomatic Bilateral Lumbar Bone Stress Injury in Adolescent Soccer Players: A Prospective Cohort Study. Am J Sports Med. 2023 Mar;51(3):707-714. doi: 10.1177/03635465221146289. Epub 2023 Jan 20. PMID 36661480

Identifiers

NCT: NCT07430072 · 821259

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗