Clinical trial NCT04533178: Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
Official title: Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Back Pain
Stress Fracture
Keywords: stress reaction
spinal brace
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2020-08-31
Enrollment: 110
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter study comparing treatment with or without soft spinal brace
Primary purpose: TREATMENT

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.

Detailed description: 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:

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

Eligibility criteria: 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)

Primary outcomes:
measure: Change in stress reaction
timeFrame: 6 weeks
Secondary outcomes:
measure: SRS-24 -score at the beginning of the treatment and during the six-month follow-up
timeFrame: 6 months
measure: Back pain
timeFrame: six months
measure: Relapse of symptoms
timeFrame: six months
measure: Vitamin D value
timeFrame: 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.
measure: Duration of pain during treatment
timeFrame: six weeks
measure: change in sacral slope
timeFrame: six months
measure: pain in one-legged back extension test
timeFrame: six months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Pori
country: Finland
facility: SataSairaala
state: Satakunta
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
city: Turku
country: Finland
facility: Mehilainen Neo Turku
state: Varsinais-Suomi
Study officials:
References: