Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study

Whiplash Injuries Clinical Trial

Official title:

Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041985
• Other study ID #: 1703016
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2021
• Source: Cantonal Hospital Dr. Safet Mujic Mostar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Whiplash Injuries
• Whiplash Injury of Cervical Spine
• Wounds and Injuries

Intervention

Drug:
• Diazepam Tablets
Diazepam 5 mg tablet once per day (bedtime) for 7 days

Locations

Country	Name	City	State
Bosnia and Herzegovina	KB "dr.Safet Mujic"	Mostar	HNK

Sponsors (1)

Lead Sponsor	Collaborator
Edin Mešanovic

Country where clinical trial is conducted

Bosnia and Herzegovina, 

References & Publications (4)

Benoist M, Rouaud JP. Whiplash: myth or reality? Joint Bone Spine. 2002 Jun;69(4):358-62. Review. — View Citation

Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine (Phila Pa 1976). 1995 Apr 15;20(8 Suppl):1S-73S. Review. Erratum in: Spine 1995 Nov 1;20(21):2372. — View Citation

Tanaka N, Atesok K, Nakanishi K, Kamei N, Nakamae T, Kotaka S, Adachi N. Pathology and Treatment of Traumatic Cervical Spine Syndrome: Whiplash Injury. Adv Orthop. 2018 Feb 28;2018:4765050. doi: 10.1155/2018/4765050. eCollection 2018. Review. — View Citation

Uehara Benites MA, Pérez-Garrigues H, Morera Pérez C. [Clinical symptoms of equilibrium disorders in patients with whiplash syndrome]. Acta Otorrinolaringol Esp. 2009 May-Jun;60(3):155-9. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in WDQ score 6 months after injury	Comparation of same score at the follow up examination 7 days after the injury	6 months
Primary	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	changes in VAS scores 7 days after the injury	Comparation of same score at the initial examination after the injury	7 days
Secondary	changes in VAS scores 6 weeks after the injury	Comparation of same score at the initial examination after the injury	6 weeks
Secondary	changes in VAS scores 6 months after the injury	Comparation of same score at the initial examination after the injury	6 months
Secondary	change in WDQ score 6 weeks after injury	Comparation of same score at the follow up examination 7 days after the injury	6 weeks
Secondary	change in NDI score 6 weeks after injury	Comparation of same score at the follow up examination 7 days after the injury	6 weeks