Compression FractureNCT02049931
Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
A study testing No brace treatment, Rigid brace and Soft brace in people with Compression Fracture, run by Seoul National University Hospital.
Trial summary
The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Compression Fracture
- What is being tested?
- No brace treatment, Rigid brace and Soft brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
- compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.
Who cannot join
- the presence of more than two recent vertebral fractures,
- pathologic malignant compression fractures,
- neurologic complications,
- a history of previous injury or surgery to the fractured level,
- inability to complete the questionnaires about pain and disability.
About this study
Official title: The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.
Read the detailed description
Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.
- Conditions
- Compression Fracture
- Being tested
- No brace treatment, Rigid brace, Soft brace
- Keywords
- osteoporosis, compression fracture, brace
- Medical subject headings
- Fractures, Compression, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No brace treatmentDevice
Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
Rigid braceDevice
In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
Soft braceDevice
In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| No brace group | Experimental | Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable. Receives: Device: No brace treatment |
| Rigid brace group | Active comparator | Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. Receives: Device: Rigid brace |
| Soft brace group | Active comparator | Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. Receives: Device: Soft brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) at 12 Weeks
The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
Measured: 12 weeks after injury
Secondary outcomes (4)
Visual Analog Pain Scale (VAS) for Back Pain
The VAS for back pain comprised a 10-cm line with "none" (0) on one end and "disabled pain" (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.
Measured: 2 weeks, 6 weeks, 12 weeks after injury
Oswestry Disability Index (ODI)
The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
Measured: at 2 weeks, 6 weeks, and 12 weeks after compression fracture.
General Health Status
The general health status was assessed with use of the Short Form-36 Health Survey (SF-36) at the initial enrollment and 12 weeks after compression fracture.The raw scores for the eight subscales and the two summaries of the SF-36 (Physical Function,Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotion, and Mental Health, as well as the Physical Component Summary [PCS] and the Mental Component Summary [MCS]) were transformed into norm-based 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, and the higher the score the less disability. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: at the initial enrollment and 12 weeks after compression fracture
the Progression of Body Compression Ratio Over All Follow-up Assessments
The anterior body compression ratio was assessed by calculating the ratio between the vertical height of the most compressed anterior section of the injured vertebral body and the posterior vertebral body height at that level
Measured: 2 weeks, 6 weeks, and 12 weeks after compression fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startDec 2012
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compression FractureStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Ho-Joong Kim, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049931
- Sponsor's protocol ID
- Brace001
- Status last verified
- Aug 2018
- First submitted
- 28 Jan 2014
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim HJ, Yi JM, Cho HG, Chang BS, Lee CK, Kim JH, Yeom JS. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1959-66. doi: 10.2106/JBJS.N.00187.
PubMed 25471910
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
- ClinicalTrials.gov ID
- NCT02049931
- Acronym / sponsor ID
- Brace001
- Conditions
- Compression Fracture
- Keywords
- osteoporosis, compression fracture, brace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Posted 25 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.
Detailed description
Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No brace group | Experimental | Device: No brace treatmentPatients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable. |
| Rigid brace group | Active comparator | Device: Rigid bracePatients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. |
| Soft brace group | Active comparator | Device: Soft braceBecause soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
- compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.
Key exclusion criteria (5 listed)
- the presence of more than two recent vertebral fractures,
- pathologic malignant compression fractures,
- neurologic complications,
- a history of previous injury or surgery to the fractured level,
- inability to complete the questionnaires about pain and disability.
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 |
|---|---|---|
| No brace treatmentPatients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable. | Device | No brace group |
| Rigid braceIn rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. | Device | Rigid brace group |
| Soft braceIn soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. | Device | Soft brace group |
Primary outcome
Oswestry Disability Index (ODI) at 12 Weeks
Time frame: 12 weeks after injury
The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
4 secondary outcomes
Visual Analog Pain Scale (VAS) for Back Pain
Time frame: 2 weeks, 6 weeks, 12 weeks after injury
Oswestry Disability Index (ODI)
Time frame: at 2 weeks, 6 weeks, and 12 weeks after compression fracture.
General Health Status
Time frame: at the initial enrollment and 12 weeks after compression fracture
the Progression of Body Compression Ratio Over All Follow-up Assessments
Time frame: 2 weeks, 6 weeks, and 12 weeks after compression fracture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25471910Kim HJ, Yi JM, Cho HG, Chang BS, Lee CK, Kim JH, Yeom JS. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1959-66. doi: 10.2106/JBJS.N.00187.
Related trials for Compression Fracture
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia
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.
Ho-Joong Kim, MD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing No brace treatment, Rigid brace and Soft brace in people with Compression Fracture, run by Seoul National University Hospital.
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 2 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: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 25 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oswestry Disability Index (ODI) at 12 Weeks (time frame: 12 weeks after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02049931, which also lists 1 linked publication.
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 7 Aug 2018.