Back PainNCT02643290
Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
A study testing Peak Scoliosis Bracing System in people with Back Pain, run by Aspen Medical Products.
Trial summary
Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic pain secondary to scoliosis. 20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Back Pain
- What is being tested?
- Peak Scoliosis Bracing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2015to Jan 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have significant back pain from idiopathic or degenerative scoliosis
- Idiopathic or degenerative scoliosis with Cobb angle > 30"
- Age > 18 years
Who cannot join
- Prior back surgery
- Secondary scoliosis
About this study
Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic pain secondary to scoliosis.
20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. The sample size was calculated considering the data collected during the development of the brace in the US. Patients will be evaluated at baseline immediately before starting with the brace and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day.
At each evaluation they will be asked to fill the questionnaires, to be used as outcome measure of the results.
Read the detailed description
Background: Some adult scoliosis patients suffer significant back pain and risk increased curvature leading to postural collapse. The main approach for these patients according to the current literature is the surgical one, however, surgery is not without complications, is not appropriate for all patients and certain patients do not choose to undergo surgery. Despite the fact that scoliosis has been estimated to affect up to 68% of the population over 60, there is scant literature about conservative treatments for adult scoliosis; a case report and a case series demonstrated the effectiveness of scoliosis specific exercise to stop progression, while another study reported the effectiveness of a soft brace in reducing pain at short time. Custom fabricated rigid torso braces, similar to those commonly used for children are sometimes used in adult patients, however, the goal of these braces is to correct and/or sustain the sagittal plane of patients, no data have been published on the efficacy of these braces in relief of pain, and such braces are typically not well tolerated by adults. Recently a new brace has become available, the Peak Scoliosis Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic pain secondary to scoliosis.
Aim: to test the efficacy of the Peak Scoliosis Brace in reducing pain in adult scoliosis patients.
Study design: prospective cohort study. Population: 20 adults with back pain secondary to Idiopathic Scoliosis. The sample size was calculated considering the data collected during the development of the brace in the US, and the first 2 patients fitted in Italy. Setting alpha at 0.05 and the power at 0.8, with a mean expected improvement of 2 point in the pain NRS, 16 patients would be necessary.
Considering the possibility of 25% drop out the investigators decided to recruit 20 subjects.
Statistical analysis: If data will be normally distributed, the investigators will use a paired t-test. Otherwise, non-parametric statistical tests will be applied.
Protocol: patients will be evaluated at baseline immediately before starting with the brace and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day. At each evaluation they will be asked to fill the NRS, Rolland Morris Questionnaire and COMI.
- Conditions
- Back Pain
- Being tested
- Peak Scoliosis Bracing System
- Keywords
- Adult Scoliosis, Pain Management, Orthosis
- Medical subject headings
- Back Pain, Scoliosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak Scoliosis Bracing SystemDevice
Brace is fit to adult scoliosis patients for 2-4 hours a day and tracked for six months.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Adult patients with low back pain secondary to an high degree scolisis are treated by fiting with a brace 2-4 hours a day and tracked for 6 months. Receives: Device: Peak Scoliosis Bracing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief
Change in pain from baseline will be measured by means of the Core Outcome Measures Index
Measured: At start, 4 weeks, 6 months
Secondary outcomes (3)
Pain Relief
Oswestry Disability Index
Measured: At start, 4 weeks, 6 months
Pain Relief
Roland Morris Disability Questionnaire
Measured: At start, 4 weeks, 6 months
Pain Relief
Numerical Rating Scale
Measured: At start, 4 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start23 Apr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspen Medical Products
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643290
- Sponsor's protocol ID
- 156_2015bis
- Status last verified
- Feb 2017
- First submitted
- 24 Dec 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Zaina F, Poggio M, Di Felice F, Donzelli S, Negrini S. Bracing adults with chronic low back pain secondary to severe scoliosis: six months results of a prospective pilot study. Eur Spine J. 2021 Oct;30(10):2962-2966. doi: 10.1007/s00586-021-06808-1. Epub 2021 Mar 17.
PubMed 33733328
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
- ClinicalTrials.gov ID
- NCT02643290
- Acronym / sponsor ID
- 156_2015bis
- Conditions
- Back Pain
- Keywords
- Adult Scoliosis, Pain Management, Orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aspen Medical ProductsUniversity, hospital or other
- Study start
- 23 Apr 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Dec 2015 (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.
Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic pain secondary to scoliosis.
20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. The sample size was calculated considering the data collected during the development of the brace in the US. Patients will be evaluated at baseline immediately before starting with the brace and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day.
At each evaluation they will be asked to fill the questionnaires, to be used as outcome measure of the results.
Detailed description
Background: Some adult scoliosis patients suffer significant back pain and risk increased curvature leading to postural collapse. The main approach for these patients according to the current literature is the surgical one, however, surgery is not without complications, is not appropriate for all patients and certain patients do not choose to undergo surgery. Despite the fact that scoliosis has been estimated to affect up to 68% of the population over 60, there is scant literature about conservative treatments for adult scoliosis; a case report and a case series demonstrated the effectiveness of scoliosis specific exercise to stop progression, while another study reported the effectiveness of a soft brace in reducing pain at short time. Custom fabricated rigid torso braces, similar to those commonly used for children are sometimes used in adult patients, however, the goal of these braces is to correct and/or sustain the sagittal plane of patients, no data have been published on the efficacy of these braces in relief of pain, and such braces are typically not well tolerated by adults. Recently a new brace has become available, the Peak Scoliosis Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic pain secondary to scoliosis.
Aim: to test the efficacy of the Peak Scoliosis Brace in reducing pain in adult scoliosis patients.
Study design: prospective cohort study. Population: 20 adults with back pain secondary to Idiopathic Scoliosis. The sample size was calculated considering the data collected during the development of the brace in the US, and the first 2 patients fitted in Italy. Setting alpha at 0.05 and the power at 0.8, with a mean expected improvement of 2 point in the pain NRS, 16 patients would be necessary.
Considering the possibility of 25% drop out the investigators decided to recruit 20 subjects.
Statistical analysis: If data will be normally distributed, the investigators will use a paired t-test. Otherwise, non-parametric statistical tests will be applied.
Protocol: patients will be evaluated at baseline immediately before starting with the brace and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day. At each evaluation they will be asked to fill the NRS, Rolland Morris Questionnaire and COMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Device: Peak Scoliosis Bracing SystemAdult patients with low back pain secondary to an high degree scolisis are treated by fiting with a brace 2-4 hours a day and tracked for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have significant back pain from idiopathic or degenerative scoliosis
- Idiopathic or degenerative scoliosis with Cobb angle > 30"
- Age > 18 years
Key exclusion criteria (2 listed)
- Prior back surgery
- Secondary scoliosis
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 |
|---|---|---|
| Peak Scoliosis Bracing SystemBrace is fit to adult scoliosis patients for 2-4 hours a day and tracked for six months. | Device | Patients |
Primary outcome
Pain Relief
Time frame: At start, 4 weeks, 6 months
Change in pain from baseline will be measured by means of the Core Outcome Measures Index
3 secondary outcomes
Pain Relief
Time frame: At start, 4 weeks, 6 months
Pain Relief
Time frame: At start, 4 weeks, 6 months
Pain Relief
Time frame: At start, 4 weeks, 6 months
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 Mar 2017.
- Derived from this study: PubMed 33733328Zaina F, Poggio M, Di Felice F, Donzelli S, Negrini S. Bracing adults with chronic low back pain secondary to severe scoliosis: six months results of a prospective pilot study. Eur Spine J. 2021 Oct;30(10):2962-2966. doi: 10.1007/s00586-021-06808-1. Epub 2021 Mar 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Peak Scoliosis Bracing System in people with 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 2 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 Mar 2017. 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?
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?
Pain Relief (time frame: At start, 4 weeks, 6 months). 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 NCT02643290, 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 3 Mar 2017.