Low Back PainNCT03675152
Treatment of Spondylolysisin Pediatric Patients.
A study testing Soft spinal brace, thoracolumbar orthosis and Excersice restriction in people with Low Back Pain and Stress Fracture, run by Turku University Hospital at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Low Back Pain, Stress Fracture
- What is being tested?
- Soft spinal brace, thoracolumbar orthosis and Excersice restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFinland
- Study dates
- 12 Jun 2016to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Spondylolisthesis
- Systemic skeletal disorder (Osteogenesis imperfecta, skeletal dysplasia)
- Lack of interest
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Satakunta central hospital
Pori, 28500
Turku university hospital
Turku, 20500
About this study
Official title: Treatment of Spondylolysis With Soft Spinal Brace vs. Boston Brace in Pediatric Patients. A Clinical Trial
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.
Read the 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
- Being tested
- Soft spinal brace, thoracolumbar orthosis, Excersice restriction
- Keywords
- spondylolysis, pediatric
- Medical subject headings
- Low Back Pain, Fractures, Stress, Spondylolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft spinal braceOther
Soft thoracolumbar brace worn 23 hours a day.
thoracolumbar orthosisOther
Hard thoracolumbar orthosis done individually molded, Worn 23 hours a day.
Excersice restrictionOther
Patients are only allowed to do isometrical excersices adviced by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Soft spinal brace | Experimental | Soft spinal brace used 23 hours a day for 4 months. Receives: Other: Soft spinal brace; Other: Excersice restriction |
| thoracolumbar orthosis | Active comparator | Thoracolumbar orthosis used 23 hours a day for 4 months. Receives: Other: thoracolumbar orthosis; Other: Excersice restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of spondylolysis in computed tomography
Bony healing on 4 month CT-scan measured in three categories: healed, healing in process, not healed.
Measured: 4 months
Secondary outcomes (13)
developement of spondylolisthesis
Lumbar spondylolisthesis at 2-year follow-up
Measured: 2 years
Pain measurement 1: Oswestry disability index
Oswestry disability index(patients over 16 years old) 0, 4, 12, 24 months. The self-completed questionnaire contains 10 questions with 6 different answer options. Each question is scored on a scale 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: Baseline, 4 months, 12months and 24 months
Pain measurement 2
Pain drawing (patients under 16 years old) 0, 4, 12, 24 months. Measures the location and surface area of the pain.
Measured: Baseline, 4 months, 12months and 24 months
Pain measurement 3
Vas (visual analogue scale) 0, 4, 12, 24 months. Measures the pain in millimeters. 0 millimeters being no pain and 10 millimeters being the worst pain a patient can imagine.
Measured: Baseline, 4 months, 12months and 24 months
Life quality: SRS-24
SRS-24 scores (scoliosis research society's scoliosis patient questionnaire) at 0, 4, 12, and 24 months. The questionnaire was first developed to measure the life quality of scoliosis patients. The SRS-24 is a disease-specific HRQoL questionnaire used to assess the current state of the patient with scoliosis, and the effects of surgery, consisting of twenty-four questions, each with a grading of one to five points, with a maximum score of 120. The questionnaire evaluates seven domains: pain, general self-image, function from back condition, activity level, postoperative self-image, postoperative function and satisfaction.
Measured: Baseline, 4 months, 12months and 24 months
Sit-up test
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. Sit-up test measures ab strength.The patient does as many sit-ups as he/she can. Maximum repetition will be 50 sit-ups.
Measured: 4 months and 24 months
back muscle test
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. In back muscle test patient will do back muscles and the measurement will be how many times one can do the movement. Maximum repetition will be 50.
Measured: 4 months and 24 months
squad test
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. In squad test it will be measured how many squads a patient can do. Maximum repetition will be 50 squads.
Measured: 4 months and 24 months
Back static hold
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. Patient will be in prone position and hold upper part of body up for as long as possible. It will be measured in seconds and the maximum hold up time is 240 seconds.
Measured: 4 months and 24 months
lumbar spine flexion
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. Lumbar spine flexion will be measured as patient bends forward in millimeters.
Measured: 4 months and 24 months
lumbar spine extension
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. Lumbar spine flexion will be measured as patient bends backward in millimeters.
Measured: 4 months and 24 months
lumbar spine rotation
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. Lumbar spine rotation will be measured with Myrins incliometer and the measurement will be grades and scaled between 0-360 degrees. The more rotation, the bigger the degree.
Measured: 4 months and 24 months
lumbar spine sidebend
Spinal mobility and strength tests will be done at 4months and 24 months follow-up visits. Lumbar spine sidebending will be measured both sides in millimeters and the result is mediane of these.
Measured: 4 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start12 Jun 2016
- Primary completion30 Jan 2022
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- patients are in two groups treated with soft spinal brace or with thoracolumbar orthosis.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Satakunta Central Hospital
- Responsible party
- Sponsor
- Investigators
- Ella Virkki, Principal investigator, pediatric surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675152
- Sponsor's protocol ID
- T45/2016
- Status last verified
- Dec 2023
- First submitted
- 21 Aug 2018
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Spondylolysis With Soft Spinal Brace vs. Boston Brace in Pediatric Patients. A Clinical Trial
- ClinicalTrials.gov ID
- NCT03675152
- Acronym / sponsor ID
- T45/2016
- Conditions
- Low Back Pain, Stress Fracture
- Keywords
- spondylolysis, pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Satakunta Central Hospital
- Study start
- 12 Jun 2016 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients are in two groups treated with soft spinal brace or with thoracolumbar orthosis.
| Arm | Type | Receives |
|---|---|---|
| Soft spinal brace | Experimental | Other: Soft spinal brace, Other: Excersice restrictionSoft spinal brace used 23 hours a day for 4 months. |
| thoracolumbar orthosis | Active comparator | Other: thoracolumbar orthosis, Other: Excersice restrictionThoracolumbar orthosis used 23 hours a day for 4 months. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Spondylolisthesis
- Systemic skeletal disorder (Osteogenesis imperfecta, skeletal dysplasia)
- Lack of interest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft spinal braceSoft thoracolumbar brace worn 23 hours a day. | Other | Soft spinal brace |
| thoracolumbar orthosisHard thoracolumbar orthosis done individually molded, Worn 23 hours a day. | Other | thoracolumbar orthosis |
| Excersice restrictionPatients are only allowed to do isometrical excersices adviced by a physiotherapist. | Other | Soft spinal brace, thoracolumbar orthosis |
Primary outcome
Healing of spondylolysis in computed tomography
Time frame: 4 months
Bony healing on 4 month CT-scan measured in three categories: healed, healing in process, not healed.
13 secondary outcomes
developement of spondylolisthesis
Time frame: 2 years
Pain measurement 1: Oswestry disability index
Time frame: Baseline, 4 months, 12months and 24 months
Pain measurement 2
Time frame: Baseline, 4 months, 12months and 24 months
Pain measurement 3
Time frame: Baseline, 4 months, 12months and 24 months
Life quality: SRS-24
Time frame: Baseline, 4 months, 12months and 24 months
Sit-up test
Time frame: 4 months and 24 months
back muscle test
Time frame: 4 months and 24 months
squad test
Time frame: 4 months and 24 months
Back static hold
Time frame: 4 months and 24 months
lumbar spine flexion
Time frame: 4 months and 24 months
lumbar spine extension
Time frame: 4 months and 24 months
lumbar spine rotation
Time frame: 4 months and 24 months
lumbar spine sidebend
Time frame: 4 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ella Virkki principal investigator
pediatric surgeon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft spinal brace, thoracolumbar orthosis and Excersice restriction in people with Low Back Pain and Stress Fracture, run by Turku University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of spondylolysis in computed tomography (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.