Clinical Efficacy of Diazepam After Whiplash
- Conditions
- Whiplash InjuriesWhiplash Injury of Cervical Spine
- Interventions
- Registration Number
- NCT05041985
- Lead Sponsor
- Edin Mešanović
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- patients who suffered cervical spine injury caused by a traffic accident in the previous 48 hours
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group A (the Test group) Diazepam Tablets arm which received Diazepam 5 mg therapy for 7 days after whiplash
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
KB "dr.Safet Mujic"
🇧🇦Mostar, HNK, Bosnia and Herzegovina