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 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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03100097

Acronym

ARREST

Enrollment

Registered

2017-04-04

Start date

2013-12-16

Completion date

2017-12-31

Last updated

2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Low Back Pain

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

Interventions

DEVICEAspen Horizon 627 LSO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in Opioid utilization	4 weeks, 8 weeks, 12 weeks	Change in Opioid utilization
Number of participants with treatment-related adverse events as assessed by questionnaire	4 weeks, 8 weeks, 12 weeks	Were any complications associated wearing of the brace noted in patients questionnaires
General Health Survey	12 weeks	SF36v2 Health Survey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026