Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis

NCT02260401 | Completed Results

• 1 other identifier: 39023
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. Through a Patient Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial) to address several critical research questions. The proposed study will answer the following key questions. Do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments? Do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? The investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Utilization of ESI

  We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months

  24 months

Secondary Outcomes (1)

• Healthcare Utilization

  24 months

Study Arms (2)

Individualized report

EXPERIMENTAL

Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.

Other: Individualized report

Individualized Reports after 24 months

NO INTERVENTION

Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.

Interventions

Individualized report OTHER

Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)

Individualized report

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients already enrolled in the LESS trial will be eligible for participation in the LESSER trial

You may not qualify if:

• none

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Janna Friedly
• Organization: University of Washington

friedlyj@uw.edu

206-744-3000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-03

Locations

US (1)