Cervical Strain
Conditions
Keywords
Cervical strain, whiplash, ibuprofen, cyclobenzaprine
Brief 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.
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.
Interventions
DRUGCyclobenzaprine
5 mg orally every 8 hours as needed
DRUGIbuprofen
Ibuprofen 400 mg every 8 hours as needed
DRUGIbuprofen plus Cyclobenzaprine
Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* neck pain within 24 hours of injury
Exclusion criteria
* Children, allergy or contraindication to any of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Daily for 1 week | — |
| Use of Rescue Medications | 24 hours | the number of patients taking additional rescue medications beyond the study meds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Resumption of Work | 1 week | — |
| Resumption of Work or School | next day | number of patients resuming regular activity the day following enrollment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cyclobenzaprine | 21 |
| Ibuprofen | 20 |
| Ibuprophen Plus Cyclobenzaprine | 20 |
| Total | 61 |
Baseline characteristics
| Characteristic | Ibuprofen | Ibuprophen Plus Cyclobenzaprine | Cyclobenzaprine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 21 Participants | 61 Participants |
| Age Continuous | 32 years STANDARD_DEVIATION 10 | 32 years STANDARD_DEVIATION 10 | 36 years STANDARD_DEVIATION 13 | 33 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 20 participants | 20 participants | 21 participants | 61 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 14 Participants | 34 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 7 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Pain
Time frame: Daily for 1 week
Primary
Use of Rescue Medications
the number of patients taking additional rescue medications beyond the study meds
Time frame: 24 hours
Population: number of patients using additionl anlagesics on the day following enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclobenzaprine | Use of Rescue Medications | 13 participants |
| Ibuprofen | Use of Rescue Medications | 9 participants |
| Ibuprophen Plus Cyclobenzaprine | Use of Rescue Medications | 9 participants |
Secondary
Resumption of Work or School
number of patients resuming regular activity the day following enrollment.
Time frame: next day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclobenzaprine | Resumption of Work or School | 8 participants |
| Ibuprofen | Resumption of Work or School | 14 participants |
| Ibuprophen Plus Cyclobenzaprine | Resumption of Work or School | 13 participants |
Secondary
Time to Resumption of Work
Time frame: 1 week