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 Grade 1 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.
Project description - A pilot study on the safety of active conservative management of lumbar stress reactions grade 1 in adolescent soccer players Bone stress injuries are often classified as either high or low risk injuries. High risk injuries are those injuries at sites prone to progressing to a complete fracture and delayed/non-union whereas low risk injuries have a more favourable natural history and have little need for surgery or prolonged weight-bearing restrictions . Lumbar spondylolysis (LS) is traditionally classified as one of these high-risk injuries. LS is a bone stress injury in a vertebra. It occurs in the pars interarticularis, at times with additional posterior structures involved, and the most common site is L5 followed by L4. These injures can by graded from 0 to 4 according to the Hollenberg Classification. LBP is reported as a common problem in soccer and is experienced by more than half of the young soccer players. LS is reported to be the most common source of low back pain (LBP) in adolescent athletes, and the incidence in adolescent athletes is two to five times higher than that in nonathletes. One study found that 48% of adolescent male soccer players with LBP had LS. In the course of the primary investigators clinical work with talented adolescent soccer players the primary investigators encountered several cases of LS, most of whom were connected to academies. In the literature, only found five articles specifically focusing on this condition in adolescent soccer players were found. Studies show that if someone has a lumbar bone stress injury and cease to play football and other physical activities, they will most likely recover. This is in line with current treatment guidelines, classifying LS as a high-risk injury, and the recommended treatment is a minimum of three months of soccer cessation. However, it has also been shown that adolescent soccer players with bone marrow edema that continue to play doesn't necessary get worse, i.e. none of the studies report on any player getting a spondylolisthesis. One study found that 100% of the grade 1 injuries healed on MRI, while only 80% of grade 3 injuries recovered. This raises a question whether LS should be treated according to its grade instead of as a homogenous diagnosis, with grade 1 being a low-risk injury. This could potentially reduce the disadvantages that comes with current practice (3 months cessation of soccer), such as drop out from soccer, negative psychosocial effects and deconditioning with possible increased risk of new/other injuries at RTP. Therefore, this study aims to test an active pain explore the management of adolescent soccer players diagnosed with LS, focusing on those categorized with grade-1 spondylosis. The primary investigators believe a less conservative treatment approach based on symptoms and without worsening of radiological findings, aiming to minimize time away from sports participation, is justifiable in this group of patients, and that this approach offers substantial health, psychosocial, and performance-related benefits. This should ideally be compared to the current management approach in a randomized controlled trial; however, prior to this, a pilot study is important to establish the feasibility of the proposed approach. Study Type: Prospective cohort study - Pilot study Subjects and recruitment 30-40 subjects aged 14-19 will be recruited in collaboration with the Norwegian FA Sports Medicine Clinic (IHS) and local primary health care clinics connected to the IHS' network. The subjects all participate in organized soccer and are therefore covered by the national sports insurance, (incorporated in their soccer license). When injured, they report the injury to the insurance company who then books an appointment at IHS in Oslo or a local primary health care practitioner connected to the IHS network, and in this case either in Oslo or Bergen. This is standard procedure for all players and all injuries, and participants in this project will follow the same routine. IHS had 595 patients between the age of 14-19 with LBP in 2023 and studies indicate that approximately 50% of soccer players in this age group have LS (. Inclusion criteria: Soccer players with lumbar stress reaction grade 1 in L4 or L5. Age: 14-19. Pain in the area of the affected vertebrae with sports activity and/or ADL. Exclusion: Not able to get MRI, other conditions/injuries that potentially could affect the result (at baseline and during follow up), disorders influencing growth. Outcome measures Primary: Lumbosacral MRI including Volumetric interpolated breath-hold examination (VIBE)-protocol (at baseline and at three months). In patients younger than 18, MRI should be considered as the preferred study as MRI has been shown to have high diagnostic value, offering advantages over CT scans by avoiding ionizing radiation exposure (15). VIBE MRI has emerged as a valuable non-invasive imaging modality for assessing sports-related osseous pathology (16) and Ang et al.(17) compared 3D VIBE MRI with multislice CT for the detection of pars stress fracture morphology (complete, incomplete or normal) of the lumbar spine, concluding that 3D T1 VIBE is 100% accurate in diagnosing complete pars fractures and has comparative diagnostic ability to CT in the detection and characterization of incomplete pars stress fractures with sensitivity and specificity of 96.7 and 92% respectively. Secondary: Pain (NPRS): Numerical Pain Rating Scale (NPRS) The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is used to measure pain in adults and children 10 years old or older. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. For construct validity, the NPRS was shown to be highly correlated with the visual analogue scale (VAS) in which pain is shown spatially as distance along a straight line, in patients with rheumatic and other chronic pain conditions (pain\>6 months): correlations range from 0.86 to 0.95. High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation. A change of 2 points on the NPRS has been shown as a clinical meaningful change in LBP at 1 and 4-week follow-up. Function/disability: The Oswestry Low Back Pain Disability Questionnaire (ODI) is a condition-specific outcome measure for patients with low back pain, with acceptable to good measurement properties (20). It is a self-report scale for low back pain functional disability and has been validated for use in a wide range of languages, among them Norwegian. It is considered as 'gold standard' for low back pain. 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. Level of activity: Data on weekly training load will be collected using the cellphone/mobile application AthleteMonitoring, where the participants will report minutes per week of sport specific and non-sport specific activity and adherence to home exercise program. This kind of load monitoring has been used in previous studies and have a protective effect against injury in adolescent athletes through intervention based on self-reported symptoms. Project timeline During the autumn of 2024 the investigators will gather focus groups consisting of players, coaches and parents and present the project including the research questions and adjust the project according to their feedback. In order to harmonize/homogenize the handling of each participant, the investigators will have a run through of all the outcome measures, physical examination and rehabilitation protocol with the therapists involved in the project. The data collection will start in 2025, and the investigators expect this to take between twelve and 18 months. Data analysis and writing the article will be done in 2026-27 (table 1). 2025 2026 2027 1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q Recruitment Data analyses Write-up For each subject, the timeline for data collection will be as follows (overview in table 2): Week 0 (first appointment with primary health care practitioner, ie. Physiotherapist) All adolescent soccer players that present with low back pain either at IHS in Oslo or the local primary health care practitioner connected to the IHS network in Bergen are potential candidates/participants in the project. They will have a standard anamnesis and physical examination, including ODI, NPRS, minutes of soccer and other physical activity per week, sleep and dietary habits. If there is a suspicion/risk of LS, the player will be referred to VIBE protocol MRI and will be asked to avoid pain provoking activities until the next appointment. Week 1 (second appointment with primary health care practitioner) If the MRI reveals a grade 1 LS, the player will be invited to participate in the project. If they accept, they will get a thorough explanation of the protocol, including answering questions weekly using the AthleteMonitoring app (see next section for details). Emphasis will also be on the importance of their feedback during the project, both when it comes to reporting activity and pain, but also on how they wish to carry out the protocol and at the same time stay in close contact with their team. Blood tests to exclude deficiencies and, if needed based on the anamnesis and blood samples, the players will be offered an appointment with a clinical nutritionist. Week 6 Evaluation using ODI and YouthBAQ Week 12 Evaluation using ODI and YouthBAQ MRI will be taken and if there is a regression or healing of the LS, no new MRI will be taken at week 26. If the LS is unchanged, the player will continue according to the protocol and will have a new MRI at week 26. If the LS has deteriorated/worsened, the player will follow the conservative treatment protocol, that is current (best) practice and will have a new MRI at week 26. Week 18 Evaluation using ODI and YouthBAQ Week 26 Evaluation using ODI and YouthBAQ Specific questions with regards to return to play, LBP, other injuries and pains and how they experienced the return to play, treatment protocol and their thoughts on the treatment protocol MRI when needed/as described above. Rehabilitation follow-up During the time of the project, the players will answer weekly questionnaires on NPRS lumbar spine (min. max. at rest, in ADL and in physical activity) and on weekly training volume (minutes per week of sport specific and non-sport specific activity), using an online survey software (AthleteMonitoring). The questionnaire will be delivered in the evening on the same day every week after all other activities (i.e. training and schoolwork) have likely been completed. Participants who have not replied to the initial questionnaire will receive a reminder 24 hours later and then manual follow-up if no response. The players will be followed up by their physiotherapist/primary health care practitioner approximately 5-8 times, depending on their progression, potential setbacks etc. and will always have the possibility to withdraw from the project (and continue the conservative treatment protocol, that is, current (best) practice. The specific intervention protocol, i.e. the different phases of rehabilitation, criteria for moving from one phase to the next, type of exercises etc. will be designed and described in accordance with the CERT check list. Analyses All collected data will be exported to SPSS or similar software and analyzed by Ben Clarsen in cooperation with the project leaders. Academic institution Western Norway University of Applied Sciences is responsible for this research project, in collaboration with the Norwegian FA Sports Medicine Clinic (Idrettens Helsesenter). Ethical approval Ethical approval was granted by the Regional committee for medical and health research ethics in Western Norway (REK Vest) and Data protection officer (NSD). Participating in the study will be quite similar to current standard practice with regards to imaging and number of visits. The participants will be followed closely with the weekly questionnaires and physical follow-ups to monitor and intervene early in case of adverse effects. The added load of use of time on additional MRI and weekly questionnaire will be minimal (approx. 10 minutes once a week) and can also be viewed as extra beneficial/thorough follow up by the participants. Therefore, the investigators do not expect significant problems in relation to ethical approval that cannot be resolved. All participants and parents/guardians will sign a declaration of content. They will be informed about data storage, and that they may withdraw from the study at any time without any consequences for them. Research data will be stored in accordance with the internal guidelines for secure data storage. The key to connect the participants' names to their number in the research (patient 1, patient 2 etc) will be stored on a password-protected PC. Only one project leader will have access to the connection key. All personally identifiable research data will be anonymized at the end of the project. The research project will be conducted in the absence of any commercial or financial relationships that could be seen as a potential conflict of interest. Funding Funding was granted by the The Norwegian Fund for Post-graduate Education of Physiotherapists. MRI's are covered by the participant's insurance (mandatory for all soccer players in organized sport) and is a standard practice for this group of patients. What this study adds The recent review by Wall et al. on LBP in adolescent athletes concludes: "Optimal diagnosis (including a better understanding between the relationship of imaging findings and clinical presentation), treatment and management methods for spondylolysis in this population should be better refined." If an active symptom-based management approach can be safely implemented, this could potentially reduce the disadvantages that comes with current practice (3 months cessation of soccer), such as drop out from soccer, negative psychosocial effects and deconditioning with possible increased risk of new/other injuries at return to sport. This will likely be a substantial improvement for the patient experience and overall health in the short term and long term. For the primary care physiotherapists treating these patients this study may provide a framework for active symptom-based management approach that could easily be implemented in current practice both to rehabilitate current injury and possibly decrease the risk of injuries related to 3-month cessation of training. This study is a first step in exploring LS rehabilitation and, if successful, may lead to further studies aiming to decrease the need for expensive MRI and altering management of LBP in this population. User participation When designing the treatment protocol, participants, coaches and other therapists have already been involved in giving feedback on wording, type of exercises and progression. Before starting the project, the investigators will gather focus groups consisting of players, coaches and parents and present the project including the research questions and adjust the project according to their feedback. Since the project aim to keep the participants in as much contact with their team as possible, the involvement of the participant and coaches and parents will be an important part when designing/personalizing the details of the rehabilitation for every individual player within the parameters set by the protocol. This will likely improve compliance, enjoyment and possibility of training more with the team than current guidelines allow. At 6-months follow up the participants will have the possibility to give feedback on their experience and opinions on the project and treatment protocol. It may be possible to invite participants to take part as patient voices during presentations of findings in congresses and courses etc. Project group/author list Bård Bogen, David Tovi and Nicolay Morland will be project leaders, in charge of the planning and day to day administration of the project. The University of Bergen is responsible for this research project, in collaboration with the Norwegian FA Sports Medicine Clinic (Idrettens Helsesenter). Follow-ups and data collection will be done by David Tovi, Nicolay Morland and Jan Henning Løken. Arne Larmo, Thomas Natvik, Ian Varley and Ben Clarsen contributes within their field of expertise when designing the project and will continue to do so when analyzing and presenting the data. Evidia will provide radiological examinations. Institution Name Role and Expertise Universtitet of Bergen / Haraldsplass Dianoness Hospital Bård Bogen Project leader, Physiotherapist PhD Tovi Fysioterapi David Tovi Project leader, Physiotherapist, Msc Vestland Idrettsmedinske Senter Nicolay Morland Project leader, Physiotherapist, Msc Idrettens Helsesenter Jan Henning Løken Physiotherapist, Msc Idrettens Helsesenter Joar Harøy Physiotherapist PhD Evidia Norway AS Arne Larmo Radiologist, MD Haukeland University Hospital Thomas Natvik Orthopaedic Surgeon, MD Nottingham Trent University Ian Varley Ass. Professor, Sports Scientist, PhD Oslo Sports Trauma Research Center Ben Clarsen Ass. Professor, Physiotherapist, PhD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Idrettsmedisinsk Klinikk, Brann Stadion
Bergen, Norway
RECRUITINGWestern Norway Center for Sports Medicine
Bergen, Norway
RECRUITINGThe Norwegian FA Sports Medicine Clinic
Oslo, Norway
RECRUITINGChange 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
Time frame: Baseline, 3 months and potentially at 6 months.
Changes in Youth Back Activity Questionnaire - norwegian version
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.
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks
Changes in Oswestry Disability Index
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.
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks
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