Whiplash Injuries, Whiplash Injury of Cervical Spine
Conditions
Keywords
whiplash, cervical spine, neck, whiplash injury, muscle spasm, diazepam, muscle strain
Brief summary
Whiplash injury is very common and lot of patients which suffered the injury have chronic symptoms despite different treatment options. One of main symptoms include muscle spasm and pain caused by neck movement. Diazepam is a well known drug which can be used to treat muscle spasms. The aim of this study is to determine whether short term Diazepam therapy can have positive effect on long term outcomes after whiplash injury.
Detailed description
This randomized, assessor-blinded study was conducted on patients presented due to a cervical spine injury caused by a traffic accident in the previous 48 hours from 1st January 2020 to 31st December 2020. All the patient which were included in this study were divided into 2 groups: group A, the Test group, and group B, the control group. All patients signed the consent to participate in the study prior to randomization. During the initial examination a detailed history was taken and it included Visual Analog Pain Scale (VAS). On follow up examinations 7 days, 6 weeks and 6 months after the injury, all patients completed Neck disability index (NDI), Whiplash disability questionnaire (WDQ) as well as Visual Analog Pain Scale (VAS). Any patient which didn't complete all the follow up examination was excluded from the study.
Interventions
DRUGDiazepam Tablets
Diazepam 5 mg tablet once per day (bedtime) for 7 days
Sponsors
Edin Mešanović
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Patients were presented with a sealed opaque envelope which contained a piece of A4 paper with inscriptions Group A or Group B. After choosing one envelope they would tell the nurse which letter they got without the assessor's knowing the group.
Intervention model description
Study group will get the recommendation to use one Diazepam 5 mg pill per day (bedtime) for 7 days after whiplash injury.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* patients who suffered cervical spine injury caused by a traffic accident in the previous 48 hours
Exclusion criteria
* younger than 18 years of age; older than 70 years of age; the presence of associated injuries; previous surgery on the cervical spine; previously diagnosed arthrosis of the cervical spine; the presence of a malignant process and previous cervical spine injuries; history of Diazepam allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Whiplash Disability Questionnaire score 6 months after injury (0-130; 0 no disability, 130 maximal disability) | 6 months | Comparation of same score at the follow up examination 7 days after the injury |
| change in Neck Disability Index score 6 months after injury (0-50, 0 - no disability 50 maximal disability) | 6 months | Comparation of same score at the follow up examination 7 days after the injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in Visual Analog Scale scores 7 days after the injury (0-10; 0-no pain 10 maximum pain level) | 7 days | Comparation of same score at the initial examination after the injury |
| changes in Visual Analog Scale scores 6 weeks after the injury (0-10; 0-no pain 10 maximum pain level) | 6 weeks | Comparation of same score at the initial examination after the injury |
| changes in Visual Analog Scale scores 6 months after the injury (0-10; 0-no pain 10 maximum pain level) | 6 months | Comparation of same score at the initial examination after the injury |
| change in Whiplash Disability Questionnaire score 6 weeks after injury (0-130; 0 no disability, 130 maximal disability) | 6 weeks | Comparation of same score at the follow up examination 7 days after the injury |
| change in Neck Disability Index score 6 weeks after injury (0-50, 0 - no disability 50 maximal disability) | 6 weeks | Comparation of same score at the follow up examination 7 days after the injury |
Countries
Bosnia and Herzegovina
Outcome results
None listed