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)

Aspen Medical Products62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Back Pain Low Back Pain

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

* 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.

Outcomes

Primary Outcomes

40% change in Oswestry Disability Index

Oswestry Disability Index

Time frame: 4 weeks

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

Were any complications associated wearing of the brace noted in patients questionnaires

Time frame: 4 weeks, 8 weeks, 12 weeks

General Health Survey

SF36v2 Health Survey

Time frame: 12 weeks