Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
1 other identifier
interventional
110
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedAugust 31, 2020
August 1, 2020
5 years
April 16, 2020
August 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in stress reaction
Change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI
6 weeks
Secondary Outcomes (7)
SRS-24 -score at the beginning of the treatment and during the six-month follow-up
6 months
Back pain
six months
Relapse of symptoms
six months
Vitamin D value
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
six weeks
- +2 more secondary outcomes
Study Arms (2)
Restriction of sports activities
ACTIVE COMPARATORNo sports during the 6 week treatment period
Restriction of sports activities and soft spinal brace
EXPERIMENTALNo sports and use of a soft spinal brace 16 hours per day during the 6 week treatment period
Interventions
Use of a soft spinal brace 16 hours per day during the 6 week treatment period.
Resting from all sports activities
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Tampere University Hospital
Tampere, Pirkanmaa, 33520, Finland
SataSairaala
Pori, Satakunta, 28500, Finland
Turku University Hospital
Turku, Southwest Finland, 20521, Finland
Mehilainen Neo Turku
Turku, Southwest Finland, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 16, 2020
First Posted
August 31, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 31, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share
Not necessary