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)

NCT ID: NCT03100097

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-16
• Study Completion Date: 2017-12-31

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.

Conditions

Back Pain; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention (Aspen Horizon 627 LSO)

Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management

Group Type: EXPERIMENTAL

Aspen Horizon 627 LSO

Intervention Type: DEVICE

Medical Management

Normal medical management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aspen Horizon 627 LSO

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aspen Medical Products

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CPR-ORTHO02-2013

Identifier Type: -

Identifier Source: org_study_id