NCT03100097

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

February 28, 2017

Last Update Submit

January 10, 2018

Conditions

Back PainLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • 40% change in Oswestry Disability Index

    Oswestry Disability Index

    4 weeks

Secondary Outcomes (3)

  • Change in Opioid utilization

    4 weeks, 8 weeks, 12 weeks

  • Number of participants with treatment-related adverse events as assessed by questionnaire

    4 weeks, 8 weeks, 12 weeks

  • General Health Survey

    12 weeks

Study Arms (2)

Intervention (Aspen Horizon 627 LSO)

EXPERIMENTAL

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

Device: Aspen Horizon 627 LSO

Medical Management

NO INTERVENTION

Normal medical management

Interventions

Aspen Horizon 627 LSODEVICE
Intervention (Aspen Horizon 627 LSO)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • o Moderate to complete disability (baseline ODI score of 21 to 80 percent)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Back PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

April 4, 2017

Study Start

December 16, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01