Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
NCT ID: NCT04533178
Last Updated: 2020-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2021-01-01
2026-12-31
Brief Summary
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Detailed Description
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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:
1. 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)
2. 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)
3. Relapse of symptoms during the six months follow-up
4. Vitamin D values at the beginning of the study
5. "Pain time table" during the 6-week period of treatment - to clarify the moment of ending of pain during treatment.
6. Change in sacral slope on lateral lumbar x-ray with axial loading during the 6 months of follow-up.
7. Pain in one-legged back extension test at 0, 6 weeks and 6 months follow-up appointments
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Restriction of sports activities
No sports during the 6 week treatment period
Resting from all sports activities
Resting from all sports activities
Restriction of sports activities and soft spinal brace
No sports and use of a soft spinal brace 16 hours per day during the 6 week treatment period
soft spinal brace
Use of a soft spinal brace 16 hours per day during the 6 week treatment period.
Resting from all sports activities
Resting from all sports activities
Interventions
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soft spinal brace
Use of a soft spinal brace 16 hours per day during the 6 week treatment period.
Resting from all sports activities
Resting from all sports activities
Eligibility Criteria
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Inclusion Criteria
* No signs of fracture line on MRI or CT
* Age between 8 and 18 years
* Written informed consent
* Low back pain
Exclusion Criteria
* 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)
8 Years
18 Years
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Kari Kangassalo
Principal investigator
Locations
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Tampere University Hospital
Tampere, Pirkanmaa, Finland
SataSairaala
Pori, Satakunta, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Mehilainen Neo Turku
Turku, Southwest Finland, Finland
Countries
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Central Contacts
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Facility Contacts
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anne salonen, M.D.
Role: primary
Sari Malmi, M.D.
Role: primary
Olli Pajulo, M.D.
Role: primary
kari kangassalo, M.D.
Role: primary
Other Identifiers
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T102/2020
Identifier Type: -
Identifier Source: org_study_id