Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
NCT04533178 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2020-08-31
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.
Conditions
- Back Pain
- Stress Fracture
Interventions
- DEVICE
-
soft spinal brace
Use of a soft spinal brace 16 hours per day during the 6 week treatment period.
- OTHER
-
Resting from all sports activities
Resting from all sports activities
Sponsors & Collaborators
-
Turku University Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-01
- Primary Completion
- 2026-01-01
- Completion
- 2026-12-31
Countries
- Finland
Study Locations
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