Healing With Venlafaxine After Injury (HELP)
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Pain |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/14/2017 |
| Start Date: | October 2012 |
| End Date: | September 2016 |
Healing With Venlafaxine After Injury: A Randomized Clinical Trial of Venlafaxine Following Motor Vehicle Collision
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.
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.
Results from both animal and human studies suggest that treatment with the
serotonin-norepinephrine reuptake inhibitor (SNRIs) venlafaxine may reduce post-MVC pain. In
addition, venlafaxine has been shown to be beneficial in reducing posttraumatic stress
disorder (PTSD) symptoms, and in some patients PTSD symptoms may contribute to reinforcing
pain persistence after trauma.
This phase IIB pilot trial will screen patients presenting to the ED after MVC for the
presence of severe axial pain (>4 on a 0-10 numeric rating scale). Sixty of these "high
risk" patients will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine
to decrease acute and persistent musculoskeletal axial pain will be assessed.
Results will be used to design a large-scale RCT assessing the efficacy of venlafaxine
intervention in decreasing acute and persistent musculoskeletal pain in high-risk patients
presenting to the ED after minor MVC.
serotonin-norepinephrine reuptake inhibitor (SNRIs) venlafaxine may reduce post-MVC pain. In
addition, venlafaxine has been shown to be beneficial in reducing posttraumatic stress
disorder (PTSD) symptoms, and in some patients PTSD symptoms may contribute to reinforcing
pain persistence after trauma.
This phase IIB pilot trial will screen patients presenting to the ED after MVC for the
presence of severe axial pain (>4 on a 0-10 numeric rating scale). Sixty of these "high
risk" patients will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine
to decrease acute and persistent musculoskeletal axial pain will be assessed.
Results will be used to design a large-scale RCT assessing the efficacy of venlafaxine
intervention in decreasing acute and persistent musculoskeletal pain in high-risk patients
presenting to the ED after minor MVC.
Inclusion Criteria:
- Between the ages of 18 and 59
- Presents to ED within 24 hours of MVC
- ED axial pain score greater than or equal to 4 (0-10 NRS)
- Clinically sober
- Willing to provide a blood sample
- Has a telephone
- Has regular access to Internet and an email address
- Able to speak and read English
- Permanent US citizen or has a green card
- Blood pressure reading(s) in ED that, when considered in the context of patient past
and current history, in the investigator's judgment does not exceed acceptable level
Exclusion Criteria:
- Axial pain score greater than 0 in the past month (0-10 NRS)
- Clinically unstable
- Fracture (other than fracture of the phalanges)
- Substantial soft tissue injury
- Hepatic failure (acute or chronic)
- Renal failure (acute or chronic)
- Coronary artery disease, including previous MI, Angina, PCTA, etc.
- History of glaucoma
- Previous congestive heart failure
- History of seizure disorder
- History of mania or psychotic disorder
- History of suicidal ideation
- Prisoner
- History and behavior indicates, in the investigator's judgment, that the participant
would likely be noncompliant with the study
- Any other condition that, in the investigator's judgment, would indicate that the
patient in unsuitable for the study (e.g. might interfere with the study, confound
interpretation, or endanger patient)
- Currently taking a monoamine oxidase inhibitor
- Currently taking medication with substantial interaction with venlafaxine, or which
could confound interpretation of study results
- Breastfeeding
- If female, either not postmenopausal (having menses within past year), or, if
childbearing potential, positive pregnancy test prior to randomization and not using
a medically acceptable form of contraception
- Exceeds acceptable chronic daily opioid use prior to MVC
- Previously on venlafaxine
- Previous allergic reaction to venlafaxine
- Antidepressant use within 2 weeks of study start (4 week if Prozac)
We found this trial at
3
sites
Grand Rapids, Michigan 49503
Principal Investigator: Jeffrey Jones, MD
Phone: 616-486-2044
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Kirsten Rindal, MD
Phone: 585-275-2909
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Gregory Fermann, MD
Phone: 513-558-8983
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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