The HELP PAIN Trial
This study is currently recruiting participants.
Verified April 2013 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Mayday Fund
University of Rochester
Spectrum Health Department of Emergency Medicine
Information provided by (Responsible Party):
Samuel McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01716377
First received: October 25, 2012
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neck Pain |
Drug: Venlafaxine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Healing With Venlafaxine After Motor Vehicle Collision |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Average neck pain [ Time Frame: 0-31 Days ] [ Designated as safety issue: Yes ]The primary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) after study drug initiation through Day 31.
Secondary Outcome Measures:
- Chronic neck pain [ Time Frame: Study day 38 through 6 months ] [ Designated as safety issue: Yes ]The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week
|
|
|
Active Comparator: Venlafaxine
37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week
|
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.
Other Name: Effexor
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Between the ages of 18 and 50
- Presents to ED within 12 hours of MVC
- ED neck pain score greater than or equal to 7 (0-10 NRS)
- European American or African American
- 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:
- Neck 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716377
Contacts
| Contact: Samuel A McLean, MD, MPH | 919-843-5931 | smclean@aims.unc.edu |
| Contact: Lauren E Ballina, BA | 919-843-6572 | lballina@aims.unc.edu |
Locations
| United States, Michigan | |
| Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Chad Sutliffe, MEd, MHA 616-486-2044 chad.sutliffe@spectrumhealth.org | |
| Principal Investigator: Jeffrey Jones, MD | |
| United States, New York | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Kian Merchant-Borna, MPH 585-275-2909 Kian_Merchant-Borna@URMC.Rochester.edu | |
| Principal Investigator: Kirsten Rindal, MD | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Mayday Fund
University of Rochester
Spectrum Health Department of Emergency Medicine
Investigators
| Principal Investigator: | Samuel A McLean, MD, MPH | University of North Carolina, Chapel Hill |
| Principal Investigator: | Jeffrey Jones, MD | Spectrum Health Hospitals |
| Principal Investigator: | Kirsten Rindal, MD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Samuel McLean, MD, Vice Chair of Research, Anesthesiology Department; Attending Physician, Department of Emergency Medicine, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01716377 History of Changes |
| Other Study ID Numbers: | 104106 |
| Study First Received: | October 25, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Neck Pain Musculoskeletal pain Venlafaxine |
Additional relevant MeSH terms:
|
Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Venlafaxine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013