Validating PROMIS Instruments in Back and Leg Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784251
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : December 11, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Dagmar Amtmann, University of Washington

Brief Summary:
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at

Condition or disease
Leg Pain Back Pain

Detailed Description:

The University of Washington Center on Outcomes Research in Rehabilitation (UWCORR) is a member of the Patient Reported Outcomes Information System (PROMIS) Network. PROMIS is funded by the NIH Roadmap initiative, working to improve the efficiency and accuracy of measuring patient-reported outcomes. UWCORR works collaboratively with five research sites (Stanford University, Duke University, State University of New York, University of Pittsburgh, and University of North Carolina) and a Statistical Coordinating Center (NorthShore University HealthSystem).

Collectively, the goal of the PROMIS Network is to create a publicly available system that can be periodically added to and modified and that allows clinical researchers to access a common repository of items and computerized adaptive tests. The first step in achieving this goal was to build item pools and develop core questionnaires that measure key health outcome domains that are manifested in a variety of disabilities and chronic conditions. The resulting six item banks cover the domains of pain, fatigue, social health, physical functioning, emotional functioning, and sleep-wake functioning.

The next step in this process is to validate the PROMIS item banks and to examine their utility as computerized adaptive tests (CATs) with individuals diagnosed with a variety of chronic conditions and disabilities. At UWCORR, we will recruit patients with back and leg pain who were treated with epidural steroid injections. This protocol is aimed at comparing the psychometric properties of the PROMIS item banks with non-PROMIS 'gold standard' instruments, diagnostic data, and medical records. We will compare de-identified data from this study with de-identified data from other PROMIS research centers.

Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validating PROMIS Instruments in Back and Leg Pain
Study Start Date : July 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Primary Outcome Measures :
  1. PROMIS measures

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with back and leg pain who are scheduled for epidural steroid injections and who have had pain for at least 6 weeks.

Inclusion Criteria:

  • Back pain for at least 6 weeks
  • Scheduled for any kind of spinal injection (i.e. epidural steroid injection, facet joint injection or sacroiliac joint injection) recommended by clinic physician

Exclusion Criteria:

  • Not scheduled for ESI
  • Has dementia or other cognitive impairments that would interfere with questionnaire completion
  • Lumbar surgery within the last year; unstable neurological symptoms (e.g., experiencing bowel or bladder incontinence, numbness in groin area, new or worsening weakness in legs, or new numbness or tingling in legs); cauda equine syndrome; cancer; spinal cord injury (SCI); vertebral fractures; or multiple sclerosis (MS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784251

United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
UWMC Sports and Spine Physicians
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Dagmar Amtmann, PhD University of Washington

Responsible Party: Dagmar Amtmann, Study Principal Investigator, University of Washington Identifier: NCT00784251     History of Changes
Other Study ID Numbers: 33606-J
5U01AR052171-02 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Dagmar Amtmann, University of Washington:
Leg pain
Back pain

Additional relevant MeSH terms:
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms