Clinical Efficacy of Diazepam After Whiplash

Phase 4CompletedNCT05041985

Edin Mešanović89 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Whiplash Injuries Whiplash Injury of Cervical Spine

Interventions

Diazepam TabletsDRUG

Diazepam 5 mg tablet once per day (bedtime) for 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

KB "dr.Safet Mujic"

Mostar, HNK, Bosnia and Herzegovina

Outcomes

Primary Outcomes

change in Whiplash Disability Questionnaire score 6 months after injury (0-130; 0 no disability, 130 maximal disability)

Comparation of same score at the follow up examination 7 days after the injury

Time frame: 6 months

change in Neck Disability Index score 6 months after injury (0-50, 0 - no disability 50 maximal disability)

Comparation of same score at the follow up examination 7 days after the injury

Time frame: 6 months

Secondary Outcomes

changes in Visual Analog Scale scores 7 days after the injury (0-10; 0-no pain 10 maximum pain level)

Comparation of same score at the initial examination after the injury

Time frame: 7 days

changes in Visual Analog Scale scores 6 weeks after the injury (0-10; 0-no pain 10 maximum pain level)

Comparation of same score at the initial examination after the injury

Time frame: 6 weeks

changes in Visual Analog Scale scores 6 months after the injury (0-10; 0-no pain 10 maximum pain level)

Comparation of same score at the initial examination after the injury

Time frame: 6 months

change in Whiplash Disability Questionnaire score 6 weeks after injury (0-130; 0 no disability, 130 maximal disability)

Comparation of same score at the follow up examination 7 days after the injury

Time frame: 6 weeks

change in Neck Disability Index score 6 weeks after injury (0-50, 0 - no disability 50 maximal disability)

Comparation of same score at the follow up examination 7 days after the injury

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.