Trial Outcomes & Findings for Pain, Psychiatric Disorders, and Disability Among Veterans With and Without Polytrauma (NCT NCT00645970)

NCT ID: NCT00645970

Last Updated: 2015-05-15

Results Overview

Numeric Pain Rating Scale is a self-report measure of "usual" (average) pain intensity over the last week; response options range from "no pain" (0) to "worst pain imaginable" (10). A score \>3 indicates moderate-to-severe pain.

• Recruitment status: COMPLETED
• Target enrollment: 359 participants
• Primary outcome timeframe: Baseline, 6 months, 1 year
• Results posted on: 2015-05-15

Participant Flow

Participant milestones

Measure	Polytrauma System of Care (PSC) Participants recruited from the Polytrauma System of Care (PSC)	Registry Participants recruited from the OEF/OIF/OND registry
Overall Study STARTED	141	218
Overall Study 6 Months	58	97
Overall Study 1 Year	37	42
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	109	186

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain, Psychiatric Disorders, and Disability Among Veterans With and Without Polytrauma

Baseline characteristics by cohort

Measure	Polytrauma System of Care (PSC) n=141 Participants Participants recruited from the Polytrauma System of Care	Registry n=218 Participants Participants recruited from the OEF/OIF/OND registry	Total n=359 Participants Total of all reporting groups
Age, Continuous	32.9 years STANDARD_DEVIATION 8.2 • n=5 Participants	36.6 years STANDARD_DEVIATION 10.3 • n=7 Participants	35.1 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	131 Participants n=5 Participants	196 Participants n=7 Participants	327 Participants n=5 Participants
Race/Ethnicity, Customized White	120 participants n=5 Participants	158 participants n=7 Participants	278 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	13 participants n=5 Participants	23 participants n=7 Participants	36 participants n=5 Participants
Race/Ethnicity, Customized Black	7 participants n=5 Participants	27 participants n=7 Participants	34 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	10 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months, 1 year

Population: Numeric Pain Rating Scale data are missing for 21 participants (PSC n=1; Registry n=20)

Numeric Pain Rating Scale is a self-report measure of "usual" (average) pain intensity over the last week; response options range from "no pain" (0) to "worst pain imaginable" (10). A score >3 indicates moderate-to-severe pain.

Outcome measures

Measure	Polytrauma System of Care (PSC) n=140 Participants Participants recruited from the Polytrauma System of Care (PSC)	Registry n=198 Participants Participants recruited from the OEF/OIF/OND registry
Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale) Baseline	4.66 units on a scale Standard Deviation 2.44	3.80 units on a scale Standard Deviation 2.46
Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale) 6 months	4.92 units on a scale Standard Deviation 2.20	3.30 units on a scale Standard Deviation 2.36
Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale) 1 year	4.88 units on a scale Standard Deviation 3.02	4.69 units on a scale Standard Deviation 2.89

Adverse Events

Polytrauma System of Care (PSC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Registry

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

Kristin Phillips

James A. Haley Veterans' Hospital

Phone: 813-972-2000

Email: kristin.phillips3@va.gov

Results disclosure agreements

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