KyphosisARISENCT02180776
Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis
A study testing Summit 456 TLSO in people with Kyphosis and Back Pain, run by Aspen Medical Products.
Trial summary
The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and… Read more about this study
- Who is it for?
- Ages 19 years and older
- What is being tested?
- Summit 456 TLSO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Mar 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire;
- Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees;
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Patients under the age of 19;
- Pregnant patients or patients who are considering future pregnancies;
- Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic;
- Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material;
- Patients who are unable or unwilling to return to the study center for follow-up visits.
About this study
Official title: A Randomized Crossover Pilot Study To Determine Clinical Effectiveness and Patient Wellness of Inelastic Lumbosacral Orthoses Versus Standard Medical Treatment in Patients With Back Pain AssociatEd With Kyphosis (The ARISE Study)
The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.
- Being tested
- Summit 456 TLSO
- Medical subject headings
- Kyphosis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summit 456 TLSOOther
Thoracolumbarsacral orthosis
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients assigned to group A wore the Summit 456 TLSO (intervention) for four weeks in phase 1 of the study, followed by four weeks of observation (control) in phase 2. Receives: Other: Summit 456 TLSO |
| Group B | Placebo comparator | Patients assigned to group B started four weeks of observation (control) in phase 1, followed by four weeks of summit 456 TLSO (intervention) in phase 2 of the study. Receives: Other: Summit 456 TLSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups
Measured: 4 weeks
Secondary outcomes (1)
Measured amount of opioid medication consumed in the intervention group versus control group
Measured: Baseline and weeks 2,3,4,8,12,16,20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspen Medical Products
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel J Schaffer, MD, Principal investigator, Southeastern Integrated Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180776
- Sponsor's protocol ID
- CPR-ORTHO01-2012
- Acronym
- ARISE
- Status last verified
- Jul 2014
- First submitted
- 23 Jan 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Pilot Study To Determine Clinical Effectiveness and Patient Wellness of Inelastic Lumbosacral Orthoses Versus Standard Medical Treatment in Patients With Back Pain AssociatEd With Kyphosis (The ARISE Study)
- ClinicalTrials.gov ID
- NCT02180776
- Acronym / sponsor ID
- ARISE / CPR-ORTHO01-2012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aspen Medical ProductsUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Jul 2014 (estimated)
- 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.
The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Summit 456 TLSOPatients assigned to group A wore the Summit 456 TLSO (intervention) for four weeks in phase 1 of the study, followed by four weeks of observation (control) in phase 2. |
| Group B | Placebo comparator | Other: Summit 456 TLSOPatients assigned to group B started four weeks of observation (control) in phase 1, followed by four weeks of summit 456 TLSO (intervention) in phase 2 of the study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire;
- Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees;
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Patients under the age of 19;
- Pregnant patients or patients who are considering future pregnancies;
- Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic;
- Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material;
- Patients who are unable or unwilling to return to the study center for follow-up visits.
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 |
|---|---|---|
| Summit 456 TLSOThoracolumbarsacral orthosis | Other | Group A, Group B |
Primary outcome
Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups
Time frame: 4 weeks
1 secondary outcome
Measured amount of opioid medication consumed in the intervention group versus control group
Time frame: Baseline and weeks 2,3,4,8,12,16,20 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
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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.
Daniel J Schaffer, MD principal investigator
Southeastern Integrated Medical
Questions about this trial
What is this clinical trial studying?
A study testing Summit 456 TLSO in people with Kyphosis and Back Pain, run by Aspen Medical Products.
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 3 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 3 Jul 2014. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups (time frame: 4 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 3 Jul 2014.