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 Products

Status: Terminated

Conditions: Back Pain; Low Back Pain

Treatments: Device: Aspen Horizon 627 LSO

Study type: Interventional

Funder types: Other

Identifiers

NCT03100097

CPR-ORTHO02-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Intervention (Aspen Horizon 627 LSO)

Experimental group

Description:

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

Treatment:

Device: Aspen Horizon 627 LSO

Medical Management

No Intervention group

Description:

Normal medical management