Neck PainPhase 2HELPNCT01716377
Healing With Venlafaxine After Injury (HELP)
A Phase 2 study testing Venlafaxine in people with Neck Pain, run by Rhode Island Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Venlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Spectrum Health
Grand Rapids, Michigan, 49503
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Venlafaxine
- Keywords
- Neck Pain, Musculoskeletal pain, Venlafaxine
- Medical subject headings
- Neck Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Effexor
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week Receives: Drug: Venlafaxine |
| Venlafaxine | Active comparator | 37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week Receives: Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-31 Days
Secondary outcomes (1)
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.
Measured: Study day 38 through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayday Fund, University of North Carolina, University of Cincinnati, Baystate Medical Center
- Responsible party
- Principal investigator, Francesca Beaudoin, Rhode Island Hospital
- Investigators
- Samuel A McLean, MD, MPH, Principal investigator, University of North Carolina, Chapel HillJeffrey Jones, MD, Principal investigator, Corewell Health WestKirsten Rindal, MD, Principal investigator, University of RochesterGregory Fermann, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716377
- Sponsor's protocol ID
- 104106
- Acronym
- HELP
- Status last verified
- Apr 2017
- First submitted
- 25 Oct 2012
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing With Venlafaxine After Injury: A Randomized Clinical Trial of Venlafaxine Following Motor Vehicle Collision
- ClinicalTrials.gov ID
- NCT01716377
- Acronym / sponsor ID
- HELP / 104106
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Musculoskeletal pain, Venlafaxine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Mayday Fund, University of North Carolina, University of Cincinnati, Baystate Medical Center
- Study start
- Oct 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Venlafaxine37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week |
| Venlafaxine | Active comparator | Drug: Venlafaxine37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenlafaxineAlso: EffexorSixty 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. | Drug | Placebo, Venlafaxine |
Primary outcome
Average neck pain
Time frame: 0-31 Days
The primary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) after study drug initiation through Day 31.
1 secondary outcome
Chronic neck pain
Time frame: Study day 38 through 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel A McLean, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Jeffrey Jones, MD principal investigator
Corewell Health West
Kirsten Rindal, MD principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venlafaxine in people with Neck Pain, run by Rhode Island Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average neck pain (time frame: 0-31 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.