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NCT01136486 Clinical Trial

Pain in Traumatic Brain Injury - Basile, MD

Head Trauma Clinical Trial

Official title:
The Role of Persistent Pain on Neuro Psychological Functioning and Community Integration in Traumatic Brain Injury

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01136486
Other study ID # 03-015
Secondary ID
Status Terminated
Phase N/A
First received June 2, 2010
Last updated May 23, 2016
Start date April 2003
Est. completion date December 2009

Study information
Verified date May 2016
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The observation through a chart review of persistent pain on neuro psychological functioning and how it applies to the community integration with patients that had suffered traumatic brain injury.

Description:

This pilot study is designed and conducted over a one year period by the PI, who then solely carried out this study from recruitment, to patient testing, to data entry. Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.

Recruitment information / eligibility
Status Terminated
Enrollment 56
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- documented history of traumatic brain injury

- 18 years or older

Exclusion Criteria:

- younger than 18 years old

- cannot read and write English

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Staten Island University Hospital Staten Island New York

Sponsors (1)
Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of Pain Severity Pain was assessed on a scale for 1 (no pain) to 10 (severe) pain. This is observational study so participants were only seen at one time point, when they were referred to the neuropsychology service. Referral No
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