Clinical trial NCT05041985: Clinical Efficacy of Diazepam After Whiplash
Official title: Clinical Efficacy of Diazepam After Whiplash
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Whiplash Injuries
Whiplash Injury of Cervical Spine
Keywords: whiplash
cervical spine
neck
whiplash injury
muscle spasm
diazepam
muscle strain
Lead sponsor: Cantonal Hospital Dr. Safet Mujic Mostar
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in Whiplash Disability Questionnaire score 6 months after injury (0-130; 0 no disability, 130 maximal disability)
timeFrame: 6 months
measure: change in Neck Disability Index score 6 months after injury (0-50, 0 - no disability 50 maximal disability)
timeFrame: 6 months
Secondary outcomes:
measure: changes in Visual Analog Scale scores 7 days after the injury (0-10; 0-no pain 10 maximum pain level)
timeFrame: 7 days
measure: changes in Visual Analog Scale scores 6 weeks after the injury (0-10; 0-no pain 10 maximum pain level)
timeFrame: 6 weeks
measure: changes in Visual Analog Scale scores 6 months after the injury (0-10; 0-no pain 10 maximum pain level)
timeFrame: 6 months
measure: change in Whiplash Disability Questionnaire score 6 weeks after injury (0-130; 0 no disability, 130 maximal disability)
timeFrame: 6 weeks
measure: change in Neck Disability Index score 6 weeks after injury (0-50, 0 - no disability 50 maximal disability)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Mostar
country: Bosnia and Herzegovina
facility: KB "dr.Safet Mujic"
state: HNK
Study officials:
References:
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. No abstract available.
citation: 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.
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.
citation: 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.