Clinical trial NCT03675152: Treatment of Spondylolysisin Pediatric Patients.
Official title: Treatment of Spondylolysis With Soft Spinal Brace vs. Boston Brace in Pediatric Patients. A Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Stress Fracture
Keywords: spondylolysis
pediatric
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Satakunta Central Hospital
First posted: 2018-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients are in two groups treated with soft spinal brace or with thoracolumbar orthosis.
Primary purpose: TREATMENT

Brief summary: A clinical trial comparing healing of unilateral or bilateral spondylolysis in children treated with a Boston thoracolumbar orthosis (brace) or with a soft spinal brace (Porostrap lumbar support) for four months. Inclusion criteria will be a child or adolescent aged between 8 and 20 years with an early uni- or bilateral defect (fracture line) in the pars interarticularis in the CT-scan with no signs of bony sclerosis. Additionally, bone marrow edema has to be confirmed in MR images (T2 sagittal) as a sign of an early lesion. Exclusion criteria will be spondylolisthesis on standing spinal radiograph, systemic skeletal disorder or lack of interest. Patient's preference defines the treatment method. Minimum follow-up time will be 2 years for all patients. According to statistical power analysis a total of 60 patients will be needed to provide evidence for the effectiveness or no effectiveness of rigid thoracolumbar orthosis on the natural history of early spondylolysis. Measured outcome parameters are 1) Bony healing on CT-scan, 2) SRS-24-score at the beginning of the treatment and during the 2-year follow-up, 3) Back and lower extremity pain at the beginning of the treatment and during the 2-year follow-up (Pain drawing including VAS-score in children under 16 years old, Oswestry disability index including VAS-score in patients over 16 years old), 4) Thoracolumbar radiographs at 2-year follow-up: Evidence of spondylolisthesis, 5) Trunk strength and spinal mobility at follow-up visits.

As part of this study, the investigators will also evaluate patients with spondylolysis treated in their hospitals before this clinical trial begun. In this retrospective study they will evaluate all patients between 8 and 20 years of age with spondylolysis, which have been treated with thoracolumbar orthosis after year 2009 and are not participating in to prospective study. Main focus will be in bony healing in CT-scans after brace treatment.

Detailed description: A clinical trial comparing effectiveness of a soft spinal brace and a rigid thoracolumbar orthosis will be performed. Patients will choose the treatment method (patient preference). One option is to be treated, as what is known as a golden standard, with a hard thoracolumbar brace (Boston brace) worn daily for four months. The other option is to be treated with a soft spinal brace for four months. The soft brace we use in this study is DJO Global's Porostrap lumbar support. Both groups cease from sporting activities and get identical physiotherapy, where the aim is to strengthen abdominal and back muscles. After four month brace treatment we will have a control appointment where a CT-scan is taken to detect the bony healing of the pars interarticularis. Other follow-up appointments will be at 12 months and 24 months. Subjective healing is measured each time with SRS-24-score and Oswestry disability Index or pain drawing. During the last appointment, approximately 2 years after beginning of the study, a standing lateral thoracolumbar radiograph is taken to detect if the patient has developed spondylolisthesis. Trunk strength and spinal mobility is measured at follow-up visits (4 months, 12months, and 24months).

SRS-24 questionnaire is a translated and modified version of the Scoliosis Research Society-22 questionnaire. The two first questions measure the intensity of the pain (1 meaning no pain and 9 referring to the worst pain imagined). The remaining 22 questions have five alternatives from 1 (the worst option) to 5 (the best option) and they intend to measure the health-related quality of life. It has been well validated and proved reliable in investigating children with scoliosis quality of life (18).

Oswestry disability Index (ODI) is an index used to evaluate patients' back and lower extremity pain translated in Finnish or Swedish (19). It consists of ten questions and VAS-score. One question is about sexual life and that's why this questionnaire is used only for patients over 16 years old. Patients under 16 years old are asked to fill a pain drawing. This also includes VAS-score.

Visual analogue score (VAS) is a numeric pain distress scale from 0 to 10, where zero refers to "no pain" and ten to " unbearable pain". Patient draws his/her pain in a line from 0 to 10. During each appointment a patient is asked to describe their back pain and/or lower extremity pain in this scale as it is included in both pain drawing and ODI.

Trunk strength and spinal mobility tests are used to evaluate the effect of the use of the brace to the muscles and movement of the trunk. The centimeters with a tape measure from the fingertips on the thigh in side-bend are measured and we grade it abnormal, if the measurement is over 2 standard deviations under the mean of the Finnish reference values (20). Non-dynamometric trunk performance is measured with repetitive sit-up, arch-up and squatting tests. The result is graded from 1 (poor) to 5 (excellent). 1 refers to 1 standard deviation or more below the mean of the normal Finnish population values and 5 to 1 standard deviation or more above this mean (21).

In MRI, from the T2 spin-echo weighted images disc degeneration is graded based on Pfirrmann classification. Grade I refers to normal disc and grade V to most advanced disc degeneration. (22).

Computed tomography (CT) is widely used to diagnose spondylolysis and to detect healing of it. It shows bony healing and nonunion (12). A standing lateral thoracolumbar radiograph is taken at last follow-up visit to determine spondylolisthesis. This is understood as an indirect sign of failure of the treatment of the spondylolysis.

Eligibility criteria: Inclusion Criteria:

* Early uni- or bilateral defect in pars interarticularis in the CT-scan
* No signs of bony sclerosis on CT
* No signs of spondylolisthesis on standing lumbar radiographs
* Bone marrow edema in lumbar spinal MR images
* Age between 8 and 20 years
* Written informed consent

Exclusion Criteria:

* Spondylolisthesis
* Systemic skeletal disorder (Osteogenesis imperfecta, skeletal dysplasia)
* Lack of interest

Primary outcomes:
measure: Healing of spondylolysis in computed tomography
timeFrame: 4 months
Secondary outcomes:
measure: developement of spondylolisthesis
timeFrame: 2 years
measure: Pain measurement 1: Oswestry disability index
timeFrame: Baseline, 4 months, 12months and 24 months
measure: Pain measurement 2
timeFrame: Baseline, 4 months, 12months and 24 months
measure: Pain measurement 3
timeFrame: Baseline, 4 months, 12months and 24 months
measure: Life quality: SRS-24
timeFrame: Baseline, 4 months, 12months and 24 months
measure: Sit-up test
timeFrame: 4 months and 24 months
measure: back muscle test
timeFrame: 4 months and 24 months
measure: squad test
timeFrame: 4 months and 24 months
measure: Back static hold
timeFrame: 4 months and 24 months
measure: lumbar spine flexion
timeFrame: 4 months and 24 months
measure: lumbar spine extension
timeFrame: 4 months and 24 months
measure: lumbar spine rotation
timeFrame: 4 months and 24 months
measure: lumbar spine sidebend
timeFrame: 4 months and 24 months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta central hospital
city: Turku
country: Finland
facility: Turku university hospital
Study officials:
affiliation: pediatric surgeon
name: Ella Virkki
role: PRINCIPAL_INVESTIGATOR
References: