Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00784251
Other study ID # 33606-J
Secondary ID 5U01AR052171-02
Status Completed
Phase N/A
First received October 30, 2008
Last updated December 10, 2013
Start date July 2008
Est. completion date June 2010

Study information

Verified date December 2013
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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 www.nihpromis.org.


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.


Recruitment information / eligibility

Status Completed
Enrollment 226
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Harborview Medical Center Seattle Washington
United States UWMC Sports and Spine Physicians Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PROMIS measures Yes
See also
  Status Clinical Trial Phase
Completed NCT05982483 - Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain N/A
Completed NCT04744246 - Muscle Activity During Load Carriage in ROTC Cadets N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Active, not recruiting NCT03680846 - Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain N/A
Completed NCT05597189 - Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain N/A
Completed NCT05342181 - Static and Dynamic Core Stability Exercises in Potpartum Back Pain N/A
Completed NCT02955342 - Back and Neck Pain in Adolescence
Completed NCT02704845 - Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain N/A
Not yet recruiting NCT02536274 - "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain" N/A
Recruiting NCT02237105 - The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Terminated NCT02239627 - Epidural Clonidine Versus Corticosteroid for Low Back Pain N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Completed NCT02254694 - The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body N/A
Completed NCT00986180 - NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain Phase 3
Terminated NCT00769626 - Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy Phase 3
Completed NCT00771758 - Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Phase 3
Withdrawn NCT00231374 - Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning N/A
Completed NCT00103675 - Sensor Measurement of Acupuncture Needle Manipulation Phase 1
Completed NCT00454064 - Cognitive-behavioural Treatment of Chronic Back Pain Phase 3