Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study
Primary Purpose
Whiplash Injuries, Whiplash Injury of Cervical Spine
Status
Completed
Phase
Phase 4
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Diazepam Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Whiplash Injuries focused on measuring whiplash, cervical spine, neck, whiplash injury, muscle spasm, diazepam, muscle strain
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
Sites / Locations
- KB "dr.Safet Mujic"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
group A (the Test group)
group B (the control group)
Arm Description
arm which received Diazepam 5 mg therapy for 7 days after whiplash
a group which did not receive Diazepam 5 mg therapy
Outcomes
Primary Outcome Measures
change in WDQ score 6 months after injury
Comparation of same score at the follow up examination 7 days after the injury
change in NDI score 6 months after injury
Comparation of same score at the follow up examination 7 days after the injury
Secondary Outcome Measures
changes in VAS scores 7 days after the injury
Comparation of same score at the initial examination after the injury
changes in VAS scores 6 weeks after the injury
Comparation of same score at the initial examination after the injury
changes in VAS scores 6 months after the injury
Comparation of same score at the initial examination after the injury
change in WDQ score 6 weeks after injury
Comparation of same score at the follow up examination 7 days after the injury
change in NDI score 6 weeks after injury
Comparation of same score at the follow up examination 7 days after the injury
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05041985
Brief Title
Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study
Official Title
Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edin Mešanović
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries, Whiplash Injury of Cervical Spine
Keywords
whiplash, cervical spine, neck, whiplash injury, muscle spasm, diazepam, muscle strain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Study group will get the recommendation to use one Diazepam 5 mg pill per day (bedtime) for 7 days after whiplash injury.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A (the Test group)
Arm Type
Experimental
Arm Description
arm which received Diazepam 5 mg therapy for 7 days after whiplash
Arm Title
group B (the control group)
Arm Type
No Intervention
Arm Description
a group which did not receive Diazepam 5 mg therapy
Intervention Type
Drug
Intervention Name(s)
Diazepam Tablets
Intervention Description
Diazepam 5 mg tablet once per day (bedtime) for 7 days
Primary Outcome Measure Information:
Title
change in WDQ score 6 months after injury
Description
Comparation of same score at the follow up examination 7 days after the injury
Time Frame
6 months
Title
change in NDI score 6 months after injury
Description
Comparation of same score at the follow up examination 7 days after the injury
Time Frame
6 months
Secondary Outcome Measure Information:
Title
changes in VAS scores 7 days after the injury
Description
Comparation of same score at the initial examination after the injury
Time Frame
7 days
Title
changes in VAS scores 6 weeks after the injury
Description
Comparation of same score at the initial examination after the injury
Time Frame
6 weeks
Title
changes in VAS scores 6 months after the injury
Description
Comparation of same score at the initial examination after the injury
Time Frame
6 months
Title
change in WDQ score 6 weeks after injury
Description
Comparation of same score at the follow up examination 7 days after the injury
Time Frame
6 weeks
Title
change in NDI score 6 weeks after injury
Description
Comparation of same score at the follow up examination 7 days after the injury
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
KB "dr.Safet Mujic"
City
Mostar
State/Province
HNK
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
7604354
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. Erratum In: Spine 1995 Nov 1;20(21):2372.
Results Reference
background
PubMed Identifier
19558900
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.
Results Reference
background
PubMed Identifier
29682354
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.
Results Reference
background
PubMed Identifier
12184430
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.
Results Reference
background
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Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study
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