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)

Not Applicable

Terminated

• Conditions: Back Pain; Low Back Pain
• Interventions: Device: Aspen Horizon 627 LSO

• Registration Number: NCT03100097
• Lead Sponsor: Aspen Medical Products

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.

Study Timeline

• Study Start: 2013-12-16
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (Aspen Horizon 627 LSO)	Aspen Horizon 627 LSO	Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management

Primary Outcome Measures

Name	Time	Method
40% change in Oswestry Disability Index	4 weeks	Oswestry Disability Index

Secondary Outcome Measures

Name	Time	Method
Change in Opioid utilization	4 weeks, 8 weeks, 12 weeks	Change in Opioid utilization
General Health Survey	12 weeks	SF36v2 Health Survey
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