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)

Low Back Pain Clinical Trial

— ARREST  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03100097
• Other study ID #: CPR-ORTHO02-2013
• Status: Terminated
• Phase: N/A
• First received: February 28, 2017
• Last updated: January 10, 2018
• Start date: December 16, 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Aspen Medical Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Aspen Horizon 627 LSO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aspen Medical Products

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	40% change in Oswestry Disability Index	Oswestry Disability Index	4 weeks
Secondary	Change in Opioid utilization	Change in Opioid utilization	4 weeks, 8 weeks, 12 weeks
Secondary	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
Secondary	General Health Survey	SF36v2 Health Survey	12 weeks