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Clinical Efficacy of Diazepam After Whiplash

NCT ID: NCT05041985

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Whiplash Injuries Whiplash Injury of Cervical Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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group A (the Test group)

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

Group Type EXPERIMENTAL

Diazepam Tablets

Intervention Type DRUG

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

group B (the control group)

a group which did not receive Diazepam 5 mg therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diazepam Tablets

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edin Mešanović

OTHER

Sponsor Role lead

Responsible Party

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Edin Mešanović

orthopedic surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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KB "dr.Safet Mujic"

Mostar, HNK, Bosnia and Herzegovina

Site Status

Countries

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Bosnia and Herzegovina

References

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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.

Reference Type BACKGROUND
PMID: 7604354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19558900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29682354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12184430 (View on PubMed)

Other Identifiers

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1703016

Identifier Type: -

Identifier Source: org_study_id