Treatment of Spondylolysisin Pediatric Patients.

NCT ID: NCT03675152

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-12
• Study Completion Date: 2024-01-30

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.

Conditions

Low Back Pain; Stress Fracture

Keywords

spondylolysis; pediatric

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Soft spinal brace

Soft spinal brace used 23 hours a day for 4 months.

Group Type: EXPERIMENTAL

Soft spinal brace

Intervention Type: OTHER

Soft thoracolumbar brace worn 23 hours a day.

Excersice restriction

Intervention Type: OTHER

Patients are only allowed to do isometrical excersices adviced by a physiotherapist.

thoracolumbar orthosis

Thoracolumbar orthosis used 23 hours a day for 4 months.

Group Type: ACTIVE_COMPARATOR

thoracolumbar orthosis

Intervention Type: OTHER

Hard thoracolumbar orthosis done individually molded, Worn 23 hours a day.

Excersice restriction

Intervention Type: OTHER

Patients are only allowed to do isometrical excersices adviced by a physiotherapist.

Interventions

Soft spinal brace

Soft thoracolumbar brace worn 23 hours a day.

Intervention Type: OTHER

thoracolumbar orthosis

Hard thoracolumbar orthosis done individually molded, Worn 23 hours a day.

Intervention Type: OTHER

Excersice restriction

Patients are only allowed to do isometrical excersices adviced by a physiotherapist.

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satakunta Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ella Virkki

Role: PRINCIPAL_INVESTIGATOR

pediatric surgeon

Locations

Satakunta central hospital

Pori, , Finland

Turku university hospital

Turku, , Finland

Countries

Finland

Other Identifiers

T45/2016

Identifier Type: -

Identifier Source: org_study_id