Trial Outcomes & Findings for Pain in Traumatic Brain Injury - Basile, MD (NCT NCT01136486)

NCT ID: NCT01136486

Last Updated: 2016-05-24

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 56 participants
• Primary outcome timeframe: Referral
• Results posted on: 2016-05-24

Participant Flow

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.

Participant milestones

Measure	Treatment Arm 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.
Overall Study STARTED	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain in Traumatic Brain Injury - Basile, MD

Baseline characteristics by cohort

Measure	Level of Severity of TBI n=56 Participants Four categories based on pain severity (no pain, mild, moderate and severe pain).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race/Ethnicity, Customized African america	12 participants n=5 Participants
Race/Ethnicity, Customized caucasian	38 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants

PRIMARY outcome

Timeframe: Referral

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.

Outcome measures

Measure	Severity of Pain by Severity of Injury n=56 Participants
Assessment of Pain Severity	7 units on a scale Standard Deviation 1.4

Adverse Events

Severity of Pain by Severity of Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rosemarie Basile

North Shore LIJ

Phone: 718 226-6501

Email: rbasile1@siuh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place