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.

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain; Stress Fracture
• Intervention / Treatment: Other: Resting from all sports activities; Device: soft spinal brace

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

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: kari kangassalo, M.D.; Phone Number: +358407419179; Email: kajuka@utu.fi
• Study Contact Backup: Name: Olli Pajulo, M.D.; Phone Number: +02 313 0000; Email: olli.pajulo@tyks.fi

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampere University Hospital
      • Contact: anne salonen, M.D.; Phone Number: +3583 311 611; Email: anne.salonen@tays.fi
  • Satakunta
    • Pori, Satakunta, Finland, 28500
      • Satasairaala
      • Contact: Sari Malmi, M.D.; Phone Number: +358262771; Email: sari.malmi@satshp.fi
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20521
      • Turku University Hospital
      • Contact: Olli Pajulo, M.D.; Phone Number: +3582 313 0000; Email: olli.pajulo@tyks.fi
    • Turku, Varsinais-Suomi, Finland
      • Mehiläinen Neo Turku
      • Contact: kari kangassalo, M.D.; Phone Number: +358407419179; Email: kajuka@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Restriction of sports activities; No sports during the 6 week treatment period	Other: Resting from all sports activities; Resting from all sports activities
Experimental: Restriction of sports activities and soft spinal brace; No sports and 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; Device: soft spinal brace; Use of a soft spinal brace 16 hours per day during the 6 week treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stress reaction	Change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Back pain	Pain drawing in children under 16 years, Oswestry disability index in children over 16 years.	six months
Relapse of symptoms	Relapse of symptoms during the six month follow-up	six months
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.
Duration of pain during treatment	"pain time table" filled by the patient during the 6 week treatment period	six weeks
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
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

Collaborators and Investigators

• Sponsor: Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: stress reaction; spinal brace
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: T102/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No