Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?

Study Overview
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Brief Summary
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A clinical trial will be conducted comparing healing of a posterior lumbar vertebra stress reaction in children treated either with cessation of sports activities for a period of six weeks and wearing a soft spinal brace 16 hours per day or cessation of sports activities only. Primary outcome is the change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI.

Detailed Description
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A clinical trial will be conducted comparing healing of an acute posterior lumbar vertebra stress reaction in children treated either with cessation of sports activities for a period of six weeks and wearing a soft spinal brace 16 hours per day or cessation of sports activities only. Inclusion criteria will be a child or an adolescent aged between 8 and 18 years with a posterior lumbar vertebra stress reaction uni- or bilaterally in one or more lumbar vertebra. Bone marrow edema in the dorsal parts of the lumbar spine must be confirmed in a recent (under 3 weeks) MRI examination. Exclusion criteria will be a fracture line (spondylolysis), spondylolisthesis or other abnormalities on lumbar CT examination. Other exclusion criteria are skeletal disorder or not consenting to be a patient in this study. 110 Patients/ participants are randomized into two groups. The first group of 55 patients is treated with cessation of all sports activities and a soft spinal brace. The other group is treated only with cessation of sports activities. Treatment in both groups is 6 weeks, starting at doctor's appointment after all necessary examinations are complete. Minimum follow-up will be 6 months. In the beginning of this study a blood plasma vitamin D values will be measured from all our patients. Patients with D-vitamin values below 50 nmol/l will receive vitamin D prescription. Lateral x-ray picture of the lumbar spine is taken with axial loading (standing) from all study patients at the beginning and at the end (6 months) of the study. This enables to see the possible change in sacral slope during the 6-month follow-up. The possible change will then indicate a change in lumbar posture during this time. This is important to clarify whether lumbar posture has a role in the etiology - and treatment - of lumbar vertebra stress injury. According to statistical power analysis a total of 110 patients - 55 in each group- will be needed to provide evidence for the effectiveness or no effectiveness of a soft spinal brace on the natural history of pars interarticularis stress reaction. Primary outcome is the change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI. Secondary outcomes are: SRS-24 - (Scoliosis Research Society) score at the beginning of the treatment and during the six-month follow-up ( at 0, 6 weeks, 6 months appointments) Back and lower extremity pain at the beginning of the treatment and during the six months follow-up (pain drawing including VAS-score (Visual Analogue Pain Score) in children under 16 years old, Oswestry disability index including VAS-score in patients over 16 years old) Relapse of symptoms during the six months follow-up Vitamin D values at the beginning of the study Pain time table during the 6-week period of treatment - to clarify the moment of ending of pain during treatment. Change in sacral slope on lateral lumbar x-ray with axial loading during the 6 months of follow-up. Pain in one-legged back extension test at 0, 6 weeks and 6 months follow-up appointments

Official Title
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Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?

Conditions
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Back Pain, Stress Fracture

Intervention / Treatment
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* Device: soft spinal brace
* Other: Resting from all sports activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uni- or bilateral acute stress reaction of pars interarticularis or other part of posterior lumbar vertebra on MRI No signs of fracture line on MRI or CT Age between 8 and 18 years Written informed consent Low back pain Exclusion Criteria: Spondylolysis Spondylolisthesis Systemic skeletal disorder (Osteogenesis imperfecta, skeletal dysplasia), osteoporosis Systemic diseases (e.g. Diabetes mellitus type 1, rheumatic diseases, inflammatory bowel diseases, Marfan syndrome) Other bony abnormalities seen on lumbar MRI examination (e.g. Scheuermann disease, L5 sacralisation, spina bifida)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter study comparing treatment with or without soft spinal brace
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restriction of sports activities<br>No sports during the 6 week treatment period | Other: Resting from all sports activities<br>* Resting from all sports activities<br>|
| Experimental: Restriction of sports activities and soft spinal brace<br>No sports and use of a soft spinal brace 16 hours per day during the 6 week treatment period | Device: soft spinal brace<br>* Use of a soft spinal brace 16 hours per day during the 6 week treatment period.<br>Other: Resting from all sports activities<br>* Resting from all sports activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress reaction | Change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SRS-24 -score at the beginning of the treatment and during the six-month follow-up | Change in SRS-24 (Scoliosis Research Society patient outcome) questionnaire score during the six month follow-up; Total amount of points possible from each visit questionnaire is 120, divided by the number of questions (max 24, depending on number of questions answered). This results in the final score that can vary from 1 to 5, where 5 is the best and 1 is the worst. | 6 months | 
| Back pain | Pain drawing in children under 16 years, Oswestry disability index in children over 16 years. | six months | 
| Relapse of symptoms | Relapse of symptoms during the six month follow-up | six months | 
| Vitamin D value | Vitamin D value (D25 Hydroxy test) is measured at the time of the first study visit, at baseline. A value below 30 ng/ml is considered low. If the value is below 30 ng/mol, total Vitamin D supplement (20 mcg/day) is prescribed for a minimum of 3 months. This is to ensure adequate Vitamin D levels for all study subjects required for bone fracture healing. | Only at start of study. The blood test for Vitamin D is taken at the first appointment / day of recruitment to this study, which is day 1 of the study. | 
| Duration of pain during treatment | pain time table filled by the patient during the 6 week treatment period | six weeks | 
| change in sacral slope | Change in sacral slope on lateral lumbar x-ray with axial loading during the 6 months of follow-up | six months | 
| pain in one-legged back extension test | pain in one-legged back extension test at 0, 6 week and 6 month follow-up appointments | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress reaction, spinal brace