Back to resultsA 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) (ARREST)
Primary Purpose
Back Pain, Low Back Pain
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aspen Horizon 627 LSO
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
Eligibility Criteria
Inclusion Criteria:
o Moderate to complete disability (baseline ODI score of 21 to 80 percent)
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (Aspen Horizon 627 LSO)
Medical Management
Arm Description
Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management
Normal medical management
Outcomes
Primary Outcome Measures
40% change in Oswestry Disability Index
Oswestry Disability Index
Secondary Outcome Measures
Change in Opioid utilization
Change in Opioid utilization
Number of participants with treatment-related adverse events as assessed by questionnaire
Were any complications associated wearing of the brace noted in patients questionnaires
General Health Survey
SF36v2 Health Survey
Full Information
NCT ID
NCT03100097
First Posted
February 28, 2017
Last Updated
January 10, 2018
Sponsor
Aspen Medical Products
1. Study Identification
Unique Protocol Identification Number
NCT03100097
Brief 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 ARREST Study)
Acronym
ARREST
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulties recruiting patients
Study Start Date
December 16, 2013 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aspen Medical Products
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (Aspen Horizon 627 LSO)
Arm Type
Experimental
Arm Description
Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management
Arm Title
Medical Management
Arm Type
No Intervention
Arm Description
Normal medical management
Intervention Type
Device
Intervention Name(s)
Aspen Horizon 627 LSO
Primary Outcome Measure Information:
Title
40% change in Oswestry Disability Index
Description
Oswestry Disability Index
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Opioid utilization
Description
Change in Opioid utilization
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Number of participants with treatment-related adverse events as assessed by questionnaire
Description
Were any complications associated wearing of the brace noted in patients questionnaires
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
General Health Survey
Description
SF36v2 Health Survey
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
o Moderate to complete disability (baseline ODI score of 21 to 80 percent)
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
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)
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