Back PainNCT04533178
Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
A study testing soft spinal brace and Resting from all sports activities in people with Back Pain and Stress Fracture, run by Turku University Hospital at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Back Pain, Stress Fracture
- What is being tested?
- soft spinal brace and Resting from all sports activities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesFinland
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites
SataSairaala
Pori, Satakunta, 28500
Sari Malmi, M.D., +358262771, sari.malmi@satshp.fi
Tampere University Hospital
Tampere, Pirkanmaa, 33520
anne salonen, M.D., +3583 311 611, anne.salonen@tays.fi
Turku University Hospital
Turku, Southwest Finland, 20521
Olli Pajulo, M.D., +3582 313 0000, olli.pajulo@tyks.fi
Mehilainen Neo Turku
Turku, Southwest Finland
kari kangassalo, M.D., +358407419179, kajuka@utu.fi
About this study
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.
Read the 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:
- 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)
- 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)
- Relapse of symptoms during the six months follow-up
- Vitamin D values at the beginning of the study
- "Pain time table" during the 6-week period of treatment - to clarify the moment of ending of pain during treatment.
- Change in sacral slope on lateral lumbar x-ray with axial loading during the 6 months of follow-up.
- Pain in one-legged back extension test at 0, 6 weeks and 6 months follow-up appointments
- Conditions
- Back Pain, Stress Fracture
- Being tested
- soft spinal brace, Resting from all sports activities
- Keywords
- stress reaction, spinal brace
- Medical subject headings
- Back Pain, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft spinal braceDevice
Use of a soft spinal brace 16 hours per day during the 6 week treatment period.
Resting from all sports activitiesOther
Resting from all sports activities
| Study group | Role | What they receive |
|---|---|---|
| Restriction of sports activities | Active comparator | No sports during the 6 week treatment period Receives: Other: Resting from all sports activities |
| Restriction of sports activities and soft spinal brace | Experimental | No sports and use of a soft spinal brace 16 hours per day during the 6 week treatment period Receives: Device: soft spinal brace; Other: Resting from all sports activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress reaction
Change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI
Measured: 6 weeks
Secondary outcomes (7)
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.
Measured: 6 months
Back pain
Pain drawing in children under 16 years, Oswestry disability index in children over 16 years.
Measured: six months
Relapse of symptoms
Relapse of symptoms during the six month follow-up
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter study comparing treatment with or without soft spinal brace
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kari Kangassalo, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533178
- Sponsor's protocol ID
- T102/2020
- Status last verified
- Aug 2020
- First submitted
- 16 Apr 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not necessary
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?
- ClinicalTrials.gov ID
- NCT04533178
- Acronym / sponsor ID
- T102/2020
- Conditions
- Back Pain, Stress Fracture
- Keywords
- stress reaction, spinal brace
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Aug 2020 (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 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:
- 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)
- 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)
- Relapse of symptoms during the six months follow-up
- Vitamin D values at the beginning of the study
- "Pain time table" during the 6-week period of treatment - to clarify the moment of ending of pain during treatment.
- Change in sacral slope on lateral lumbar x-ray with axial loading during the 6 months of follow-up.
- Pain in one-legged back extension test at 0, 6 weeks and 6 months follow-up appointments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter study comparing treatment with or without soft spinal brace
| Arm | Type | Receives |
|---|---|---|
| Restriction of sports activities | Active comparator | Other: Resting from all sports activitiesNo sports during the 6 week treatment period |
| Restriction of sports activities and soft spinal brace | Experimental | Device: soft spinal brace, Other: Resting from all sports activitiesNo sports and use of a soft spinal brace 16 hours per day during the 6 week treatment period |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 braceUse of a soft spinal brace 16 hours per day during the 6 week treatment period. | Device | Restriction of sports activities and soft spinal brace |
| Resting from all sports activitiesResting from all sports activities | Other | Restriction of sports activities, Restriction of sports activities and soft spinal brace |
Primary outcome
Change in stress reaction
Time frame: 6 weeks
Change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI
7 secondary outcomes
SRS-24 -score at the beginning of the treatment and during the six-month follow-up
Time frame: 6 months
Back pain
Time frame: six months
Relapse of symptoms
Time frame: six months
Vitamin D value
Time frame: 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
Time frame: six weeks
change in sacral slope
Time frame: six months
pain in one-legged back extension test
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No. Not necessary
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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.
4 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 and Resting from all sports activities in people with Back Pain and Stress Fracture, run by Turku University Hospital at 4 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kari Kangassalo, M.D. (+358407419179, kajuka@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stress reaction (time frame: 6 weeks). 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 31 Aug 2020.