Back PainARRESTNCT03100097
A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers (The ARREST Study)
A study testing Aspen Horizon 627 LSO in people with Back Pain and Low Back Pain, run by Aspen Medical Products.
Trial summary
The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Back Pain, Low Back Pain
- What is being tested?
- Aspen Horizon 627 LSO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2013to Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Moderate to complete disability (baseline ODI score of 21 to 80 percent)
Who cannot join
- Pregnant patients
- Patients considering pregnancy
- Patients in any other investigational device or drug study
- Patients unwilling to return for follow up
- Patients unwilling to provide access to medical claims associated with pain management.
About this study
Official title: A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers
The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.
Read the detailed description
The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.
- Conditions
- Back Pain, Low Back Pain
- Being tested
- Aspen Horizon 627 LSO
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspen Horizon 627 LSODevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Aspen Horizon 627 LSO) | Experimental | Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management Receives: Device: Aspen Horizon 627 LSO |
| Medical Management | No intervention | Normal medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
40% change in Oswestry Disability Index
Oswestry Disability Index
Measured: 4 weeks
Secondary outcomes (3)
Change in Opioid utilization
Change in Opioid utilization
Measured: 4 weeks, 8 weeks, 12 weeks
Number of participants with treatment-related adverse events as assessed by questionnaire
Were any complications associated wearing of the brace noted in patients questionnaires
Measured: 4 weeks, 8 weeks, 12 weeks
General Health Survey
SF36v2 Health Survey
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start16 Dec 2013
- Primary completionJun 2017
- Study completionDec 2017
Why it stopped: Difficulties recruiting patients
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.
- 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
- 62 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
- NCT03100097
- Sponsor's protocol ID
- CPR-ORTHO02-2013
- Acronym
- ARREST
- Status last verified
- Jan 2018
- First submitted
- 28 Feb 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers
- ClinicalTrials.gov ID
- NCT03100097
- Acronym / sponsor ID
- ARREST / CPR-ORTHO02-2013
- Conditions
- Back Pain, Low Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties recruiting patients
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Aspen Medical ProductsUniversity, hospital or other
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Apr 2017 (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.
The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.
Detailed description
The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Aspen Horizon 627 LSO) | Experimental | Device: Aspen Horizon 627 LSOPatients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management |
| Medical Management | No intervention | –Normal medical management |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- o Moderate to complete disability (baseline ODI score of 21 to 80 percent)
Key exclusion criteria (5 listed)
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 |
|---|---|---|
| Aspen Horizon 627 LSO | Device | Intervention (Aspen Horizon 627 LSO) |
Primary outcome
40% change in Oswestry Disability Index
Time frame: 4 weeks
Oswestry Disability Index
3 secondary outcomes
Change in Opioid utilization
Time frame: 4 weeks, 8 weeks, 12 weeks
Number of participants with treatment-related adverse events as assessed by questionnaire
Time frame: 4 weeks, 8 weeks, 12 weeks
General Health Survey
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Difficulties recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
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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 Aspen Horizon 627 LSO in people with Back Pain and Low 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 1 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: stopped early, as of the sponsor's last update on 12 Jan 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?
The study was stopped early (reason given: Difficulties recruiting patients). 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?
40% change in Oswestry Disability Index (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 12 Jan 2018.