A Prospective, Multicenter, Randomized Control Study To D... | NCT03100097

Studies
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)

NCT03100097

Sponsor

Aspen Medical Products

Status

Terminated

Last Update Posted

Jan 12, 2018Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Back Pain
Low Back Pain

Interventions

Aspen Horizon 627 LSO

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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)

Official Title

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties recruiting patients

Expanded Access Info

Start Date

Dec 16, 2013Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Feb 28, 2017

First Submission Date that Met QC Criteria

Mar 29, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2018

Last Update Posted Date

Jan 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention (Aspen Horizon 627 LSO)	Experimental	Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management	Device: Aspen Horizon 627 LSO
Medical Management	No Intervention	Normal medical management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspen Horizon 627 LSO	Device		Intervention (Aspen Horizon 627 LSO)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
40% change in Oswestry Disability Index	Oswestry Disability Index	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Opioid utilization	Change in Opioid utilization	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms