Cervical StrainPhase 2NCT00790270
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
A Phase 2 study testing Cyclobenzaprine, Ibuprofen and Ibuprofen plus Cyclobenzaprine in people with Cervical Strain, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Strain
- What is being tested?
- Cyclobenzaprine, Ibuprofen and Ibuprofen plus Cyclobenzaprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2004
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neck pain within 24 hours of injury
Who cannot join
- Children, allergy or contraindication to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.
Read the detailed description
Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.
- Conditions
- Cervical Strain
- Being tested
- Cyclobenzaprine, Ibuprofen, Ibuprofen plus Cyclobenzaprine
- Keywords
- Cervical strain, whiplash, ibuprofen, cyclobenzaprine
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclobenzaprineDrug
Also called flexeril
5 mg orally every 8 hours as needed
IbuprofenDrug
Also called motrin, advil
Ibuprofen 400 mg every 8 hours as needed
Ibuprofen plus CyclobenzaprineDrug
Also called motrin or advil with flexeril
Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
| Study group | Role | What they receive |
|---|---|---|
| Cyclobenzaprine | Active comparator | Not described Receives: Drug: Cyclobenzaprine |
| Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
| Ibuprophen plus Cyclobenzaprine | Experimental | Not described Receives: Drug: Ibuprofen plus Cyclobenzaprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: Daily for 1 week
Use of Rescue Medications
the number of patients taking additional rescue medications beyond the study meds
Measured: 24 hours
Secondary outcomes (2)
Time to Resumption of Work
Measured: 1 week
Resumption of Work or School
number of patients resuming regular activity the day following enrollment.
Measured: next day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJan 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical StrainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Investigators
- adam singer, md, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790270
- Sponsor's protocol ID
- SB2003-1234
- Status last verified
- Oct 2012
- First submitted
- 12 Nov 2008
- Last updated
- 21 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00790270
- Acronym / sponsor ID
- SB2003-1234
- Conditions
- Cervical Strain
- Keywords
- Cervical strain, whiplash, ibuprofen, cyclobenzaprine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 21 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.
Detailed description
Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cyclobenzaprine | Active comparator | Drug: Cyclobenzaprine |
| Ibuprofen | Active comparator | Drug: Ibuprofen |
| Ibuprophen plus Cyclobenzaprine | Experimental | Drug: Ibuprofen plus Cyclobenzaprine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- neck pain within 24 hours of injury
Key exclusion criteria (1 listed)
- Children, allergy or contraindication to any of the study drugs
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 |
|---|---|---|
| CyclobenzaprineAlso: flexeril5 mg orally every 8 hours as needed | Drug | Cyclobenzaprine |
| IbuprofenAlso: motrin, advilIbuprofen 400 mg every 8 hours as needed | Drug | Ibuprofen |
| Ibuprofen plus CyclobenzaprineAlso: motrin or advil with flexerilIbuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed | Drug | Ibuprophen plus Cyclobenzaprine |
Primary outcome
Pain
Time frame: Daily for 1 week
Use of Rescue Medications
Time frame: 24 hours
the number of patients taking additional rescue medications beyond the study meds
2 secondary outcomes
Time to Resumption of Work
Time frame: 1 week
Resumption of Work or School
Time frame: next day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Strain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Not yet recruiting
Kinesio Taping for Upper Trapezius Myofascial Trigger Points
Myofascial Pain Syndromes, Myofascial Trigger Point Pain
Recruiting
Strain Counter Strain With and Without Sustained Natural Aphophyseal Glide in Non Specific Neck Pain
Cervical Pain
RecruitingPhase 2
Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion
Not yet recruitingPhase 2
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
HPV, High-risk HPV (Any Strain)
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.
adam singer, md principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclobenzaprine, Ibuprofen and Ibuprofen plus Cyclobenzaprine in people with Cervical Strain, run by Stony Brook University at 1 site 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 1 inclusion and 1 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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain (time frame: Daily for 1 week). The study lists 2 primary outcomes in all. 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 21 Nov 2012.