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) (ARREST)

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 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 Overview

• Status: Terminated
• Conditions: Back Pain; Low Back Pain
• Intervention / Treatment: Device: Aspen Horizon 627 LSO

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention (Aspen Horizon 627 LSO); Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management	Device: Aspen Horizon 627 LSO
NO_INTERVENTION: Medical Management; Normal medical management

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	4 weeks, 8 weeks, 12 weeks
General Health Survey	SF36v2 Health Survey	12 weeks

Collaborators and Investigators

• Sponsor: Aspen Medical Products

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2013
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (ACTUAL): April 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CPR-ORTHO02-2013