Healing With Venlafaxine After Injury (HELP)

Summary

Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine administration in reducing acute and chronic musculoskeletal pain in individuals presenting to the ED for evaluation after motor vehicle collision.

Participants: Participants will consist of 60 patients between the ages of 18-50 who present to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain score \> 6 will be screened for further eligibility.

Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60 high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6 weeks, 4 months, and 6 months post-MVC.

Conditions

• Neck Pain

Interventions

DRUG

Venlafaxine

Sixty patients who present following a minor motor vehicle collision will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed.

Sponsors & Collaborators

• Mayday Fund

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Baystate Medical Center

  collaborator OTHER

• Rhode Island Hospital

  lead OTHER

Principal Investigators

• Samuel A McLean, MD, MPH · University of North Carolina, Chapel Hill

• Jeffrey Jones, MD · Spectrum Health Hospitals

• Kirsten Rindal, MD · University of Rochester

• Gregory Fermann, MD · University of Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• United States

Study Locations