Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study

Sponsor

Edin Mešanović (Other)

Overall Status

Completed

CT.gov ID

NCT05041985

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Whiplash Injuries Whiplash Injury of Cervical Spine	Drug: Diazepam Tablets	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.Study group will get the recommendation to use one Diazepam 5 mg pill per day (bedtime) for 7 days after whiplash injury.

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.

Primary Purpose:

Treatment

Official Title:

Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: group A (the Test group)

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

Drug: Diazepam Tablets

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

No Intervention: group B (the control group)

a group which did not receive Diazepam 5 mg therapy

Outcome Measures

Primary Outcome Measures

change in WDQ score 6 months after injury [6 months]
Comparation of same score at the follow up examination 7 days after the injury
change in NDI score 6 months after injury [6 months]
Comparation of same score at the follow up examination 7 days after the injury

Secondary Outcome Measures

changes in VAS scores 7 days after the injury [7 days]
Comparation of same score at the initial examination after the injury
changes in VAS scores 6 weeks after the injury [6 weeks]
Comparation of same score at the initial examination after the injury
changes in VAS scores 6 months after the injury [6 months]
Comparation of same score at the initial examination after the injury
change in WDQ score 6 weeks after injury [6 weeks]
Comparation of same score at the follow up examination 7 days after the injury
change in NDI score 6 weeks after injury [6 weeks]
Comparation of same score at the follow up examination 7 days after the injury

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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