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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| Nottingham Trent University | OTHER |
| Federation Internationale de Football Association | OTHER |
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Introduction: The Background
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rehabilitation of low grade lumbar spondylolysis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bård E Bogen, Professor | Contact | +4791157142 | bard.e.bogen@uib.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Idrettsmedisinsk Klinikk, Brann Stadion | Bergen | 5052 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27707738 | Background | 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. | |
| 34249374 | Background | 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. |
| Label | URL |
|---|---|
| Link to site with current and past reseach projects | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study protocol | Study Protocol | View IPD |
Anonymized raw data sheet will be shared upon request or added to submission if required
From project end, approx. 2027 and five years onward.
Anyone will be able to request the data provided by the researchers upon request via e-mail.
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|
|
| 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. | Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks |
| Western Norway Center for Sports Medicine | Bergen | 5058 | Norway |
|
| The Norwegian FA Sports Medicine Clinic | Oslo | 1177 | Norway |
|
| 14582557 | Background | 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. |
| 15928561 | Background | 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. |
| 29474097 | Background | 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. |
| 28942567 | Background | 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. |
| 33844489 | Background | 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. |
| 36661480 | Background | 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. |
| 32883336 | Background | Yokoe T, Tajima T, Sugimura H, Kubo S, Nozaki S, Yamaguchi N, Morita Y, Chosa E. Comparison of symptomatic spondylolysis in young soccer and baseball players. J Orthop Surg Res. 2020 Sep 3;15(1):378. doi: 10.1186/s13018-020-01910-4. |
| 16093537 | Background | El Rassi G, Takemitsu M, Woratanarat P, Shah SA. Lumbar spondylolysis in pediatric and adolescent soccer players. Am J Sports Med. 2005 Nov;33(11):1688-93. doi: 10.1177/0363546505275645. Epub 2005 Aug 10. |
| 31460956 | Background | Selhorst M, Fischer A, MacDonald J. Prevalence of Spondylolysis in Symptomatic Adolescent Athletes: An Assessment of Sport Risk in Nonelite Athletes. Clin J Sport Med. 2019 Sep;29(5):421-425. doi: 10.1097/JSM.0000000000000546. |
| 36150752 | Background | Wall J, Meehan WP 3rd, Trompeter K, Gissane C, Mockler D, van Dyk N, Wilson F. Incidence, prevalence and risk factors for low back pain in adolescent athletes: a systematic review and meta-analysis. Br J Sports Med. 2022 Nov;56(22):1299-1306. doi: 10.1136/bjsports-2021-104749. Epub 2022 Sep 23. |
| 34498823 | Background | Cugusi L, Manca A, Fischbach E, Secci C, Bergamin M, Gobbo S, DI Blasio A, Montella A, Bandiera P, Deriu F. Low back pain prevalence and risk factors in Italian adolescent male soccer players: results from an online survey. J Sports Med Phys Fitness. 2022 Aug;62(8):1088-1094. doi: 10.23736/S0022-4707.21.12696-9. Epub 2021 Sep 9. |
| 24839041 | Background | Tunas P, Nilstad A, Myklebust G. Low back pain in female elite football and handball players compared with an active control group. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2540-7. doi: 10.1007/s00167-014-3069-3. Epub 2014 May 18. |
| 24968798 | Background | van Hilst J, Hilgersom NF, Kuilman MC, Kuijer PP, Frings-Dresen MH. Low back pain in young elite field hockey players, football players and speed skaters: Prevalence and risk factors. J Back Musculoskelet Rehabil. 2015;28(1):67-73. doi: 10.3233/BMR-140491. |
| 11805665 | Background | Hollenberg GM, Beattie PF, Meyers SP, Weinberg EP, Adams MJ. Stress reactions of the lumbar pars interarticularis: the development of a new MRI classification system. Spine (Phila Pa 1976). 2002 Jan 15;27(2):181-6. doi: 10.1097/00007632-200201150-00012. |
| 27755499 | Background | Sakai T, Tezuka F, Yamashita K, Takata Y, Higashino K, Nagamachi A, Sairyo K. Conservative Treatment for Bony Healing in Pediatric Lumbar Spondylolysis. Spine (Phila Pa 1976). 2017 Jun 15;42(12):E716-E720. doi: 10.1097/BRS.0000000000001931. |
| 25103133 | Background | Warden SJ, Davis IS, Fredericson M. Management and prevention of bone stress injuries in long-distance runners. J Orthop Sports Phys Ther. 2014 Oct;44(10):749-65. doi: 10.2519/jospt.2014.5334. Epub 2014 Aug 7. |
| Rehab protocol | Rehab protocol | View IPD |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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