Back Pain Clinical Trial
Official title:
Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
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.
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | December 31, 2026 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Finland | SataSairaala | Pori | Satakunta |
Finland | Tampere University Hospital | Tampere | Pirkanmaa |
Finland | Mehilainen Neo Turku | Turku | Varsinais-Suomi |
Finland | Turku University Hospital | Turku | Varsinais-Suomi |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in stress reaction | Change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI | 6 weeks | |
Secondary | 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 | |
Secondary | Back pain | Pain drawing in children under 16 years, Oswestry disability index in children over 16 years. | six months | |
Secondary | Relapse of symptoms | Relapse of symptoms during the six month follow-up | six months | |
Secondary | 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. | |
Secondary | Duration of pain during treatment | "pain time table" filled by the patient during the 6 week treatment period | six weeks | |
Secondary | 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 | |
Secondary | 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 |
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