Clinical Efficacy of Diazepam After Whiplash

Edin Mešanović

Status and phase: Completed; Phase 4

Conditions: Whiplash Injury of Cervical Spine; Whiplash Injuries

Treatments: Drug: Diazepam Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05041985

1703016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 2 patient groups

group A (the Test group)

Experimental group

Description:

arm which received Diazepam 5 mg therapy for 7 days after whiplash

Treatment:

Drug: Diazepam Tablets

group B (the control group)

No Intervention group

Description:

a group which did not receive Diazepam 5 mg therapy