Clinical Efficacy of Diazepam After Whiplash

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.

Study Overview

• Status: Completed
• Conditions: Whiplash Injuries; Whiplash Injury of Cervical Spine
• Intervention / Treatment: Drug: Diazepam Tablets

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • HNK
    • Mostar, HNK, Bosnia and Herzegovina, 88000
      • KB "dr.Safet Mujic"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	6 weeks

Collaborators and Investigators

• Sponsor: Edin Mešanović

Publications and helpful links

General Publications

• 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. No abstract available. Erratum In: Spine 1995 Nov 1;20(21):2372.
• Uehara Benites MA, Perez-Garrigues H, Morera Perez C. [Clinical symptoms of equilibrium disorders in patients with whiplash syndrome]. Acta Otorrinolaringol Esp. 2009 May-Jun;60(3):155-9. Spanish.
• 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.
• Benoist M, Rouaud JP. Whiplash: myth or reality? Joint Bone Spine. 2002 Jun;69(4):358-62. doi: 10.1016/s1297-319x(02)00410-4. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 4, 2021
• First Submitted That Met QC Criteria: September 4, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: whiplash; neck; cervical spine; muscle spasm; diazepam; whiplash injury; muscle strain
• Additional Relevant MeSH Terms: Neck Injuries; Wounds and Injuries; Whiplash Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Anesthetics; Central Nervous System Depressants; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: 1703016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: I am ready to share all IPD that underlie results in a publication
• IPD Sharing Time Frame: I would be ready to share the IPD after publication.
• IPD Sharing Access Criteria: I would like to be included in process of who is getting the IPD.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No