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Completed

NCT Number: NCT05041985

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.

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Key information

Conditions

Whiplash Injuries Neck Injuries Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Sprains and Strains Whiplash Injury of Cervical Spine Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KB "dr.Safet Mujic"

Mostar, HNK, 88000, Bosnia and Herzegovina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazepam Tablets

Drug

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

Primary outcomes

  1. change in Whiplash Disability Questionnaire score 6 months after injury (0-130; 0 no disability, 130 maximal disability)

    Time frame: 6 months

    Comparation of same score at the follow up examination 7 days after the injury

  2. change in Neck Disability Index score 6 months after injury (0-50, 0 - no disability 50 maximal disability)

    Time frame: 6 months

    Comparation of same score at the follow up examination 7 days after the injury

Secondary outcomes

  1. changes in Visual Analog Scale scores 7 days after the injury (0-10; 0-no pain 10 maximum pain level)

    Time frame: 7 days

    Comparation of same score at the initial examination after the injury

  2. changes in Visual Analog Scale scores 6 weeks after the injury (0-10; 0-no pain 10 maximum pain level)

    Time frame: 6 weeks

    Comparation of same score at the initial examination after the injury

  3. changes in Visual Analog Scale scores 6 months after the injury (0-10; 0-no pain 10 maximum pain level)

    Time frame: 6 months

    Comparation of same score at the initial examination after the injury

  4. change in Whiplash Disability Questionnaire score 6 weeks after injury (0-130; 0 no disability, 130 maximal disability)

    Time frame: 6 weeks

    Comparation of same score at the follow up examination 7 days after the injury

  5. change in Neck Disability Index score 6 weeks after injury (0-50, 0 - no disability 50 maximal disability)

    Time frame: 6 weeks

    Comparation of same score at the follow up examination 7 days after the injury

Sponsors and collaborators

Lead sponsor

Edin Mešanović

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2021
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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