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Healing With Venlafaxine After Injury (HELP) (HELP)

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Venlafaxine
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neck Pain focused on measuring Neck Pain, Musculoskeletal pain, Venlafaxine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Spectrum Health
  • University of Rochester Medical Center
  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Venlafaxine

Arm Description

37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week

37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week

Outcomes

Primary Outcome Measures

Average neck pain
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
The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.

Full Information

First Posted
October 25, 2012
Last Updated
April 12, 2017
Sponsor
Rhode Island Hospital
Collaborators
Mayday Fund, University of North Carolina, University of Cincinnati, Baystate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01716377
Brief Title
Healing With Venlafaxine After Injury (HELP)
Acronym
HELP
Official Title
Healing With Venlafaxine After Injury: A Randomized Clinical Trial of Venlafaxine Following Motor Vehicle Collision
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
Mayday Fund, University of North Carolina, University of Cincinnati, Baystate Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Musculoskeletal pain, Venlafaxine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week
Arm Title
Venlafaxine
Arm Type
Active Comparator
Arm Description
37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
Effexor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average neck pain
Description
The primary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) after study drug initiation through Day 31.
Time Frame
0-31 Days
Secondary Outcome Measure Information:
Title
Chronic neck pain
Description
The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.
Time Frame
Study day 38 through 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel A McLean, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Jones, MD
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirsten Rindal, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory Fermann, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Healing With Venlafaxine After Injury (HELP)

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