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Pain in Traumatic Brain Injury - Basile, MD

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01136486
Enrollment
56
Registered
2010-06-03
Start date
2003-04-30
Completion date
2009-12-31
Last updated
2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Trauma

Keywords

head trauma; traumatic brain injury

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* documented history of traumatic brain injury * 18 years or older

Exclusion criteria

* younger than 18 years old * cannot read and write English

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Pain SeverityReferralPain 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.

Countries

United States

Participant flow

Recruitment details

Patients with a documented history of head trauma ranging from mild to severe, with and without complaints of pain presented to Staten Island University Hospital over a 1 year period were considered for this study.

Participants by arm

ArmCount
Level of Severity of TBI
Four categories based on pain severity (no pain, mild, moderate and severe pain).
56
Total56

Baseline characteristics

CharacteristicLevel of Severity of TBI
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
56 Participants
Age, Continuous43 years
STANDARD_DEVIATION 7
Race/Ethnicity, Customized
African america
12 participants
Race/Ethnicity, Customized
Asian
1 participants
Race/Ethnicity, Customized
caucasian
38 participants
Race/Ethnicity, Customized
Hispanic
5 participants
Region of Enrollment
United States
56 participants
Sex: Female, Male
Female
22 Participants
Sex: Female, Male
Male
34 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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.

Time frame: Referral

ArmMeasureValue (MEAN)Dispersion
Severity of Pain by Severity of InjuryAssessment of Pain Severity7 units on a scaleStandard Deviation 1.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026