A Phase 2 interventional study of Venlafaxine in Neck Pain, sponsored by Rhode Island Hospital. Completed at 3 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Rhode Island Hospital · Phase 2, Interventional, and Prevention
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.
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 20 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week
Drug: 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.
Also known as: Effexor
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.
Time frame: 0-31 Days
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.
Time frame: Study day 38 through 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Rhode Island Hospital