Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study

Conditions
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Whiplash Injuries, Whiplash Injury of Cervical Spine

Intervention / Treatment
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* Drug: Diazepam Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study group will get the recommendation to use one Diazepam 5 mg pill per day (bedtime) for 7 days after whiplash injury.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A (the Test group)<br>arm which received Diazepam 5 mg therapy for 7 days after whiplash | Drug: Diazepam Tablets<br>* Diazepam 5 mg tablet once per day (bedtime) for 7 days<br>|
| No Intervention: group B (the control group)<br>a group which did not receive Diazepam 5 mg therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in WDQ score 6 months after injury | Comparation of same score at the follow up examination 7 days after the injury | 6 months | 
| change in NDI score 6 months after injury | Comparation of same score at the follow up examination 7 days after the injury | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in VAS scores 7 days after the injury | Comparation of same score at the initial examination after the injury | 7 days | 
| changes in VAS scores 6 weeks after the injury | Comparation of same score at the initial examination after the injury | 6 weeks | 
| changes in VAS scores 6 months after the injury | Comparation of same score at the initial examination after the injury | 6 months | 
| change in WDQ score 6 weeks after injury | Comparation of same score at the follow up examination 7 days after the injury | 6 weeks | 
| change in NDI score 6 weeks after injury | Comparation of same score at the follow up examination 7 days after the injury | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whiplash, cervical spine, neck, whiplash injury, muscle spasm, diazepam, muscle strain