Whiplash InjuriesPhase 4NCT05041985
Clinical Efficacy of Diazepam After Whiplash
A Phase 4 study testing Diazepam Tablets in people with Whiplash Injuries and Whiplash Injury of Cervical Spine, run by Edin Mešanović at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash Injuries, Whiplash Injury of Cervical Spine
- What is being tested?
- Diazepam Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who suffered cervical spine injury caused by a traffic accident in the previous 48 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
KB "dr.Safet Mujic"
Mostar, HNK, 88000
About this study
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.
Read the 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.
- Being tested
- Diazepam Tablets
- Keywords
- whiplash, cervical spine, neck, whiplash injury, muscle spasm, diazepam, muscle strain
- Medical subject headings
- Whiplash Injuries, Spasm, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazepam TabletsDrug
Diazepam 5 mg tablet once per day (bedtime) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| group A (the Test group) | Experimental | arm which received Diazepam 5 mg therapy for 7 days after whiplash Receives: Drug: Diazepam Tablets |
| group B (the control group) | No intervention | a group which did not receive Diazepam 5 mg therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edin Mešanović
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edin Mešanović, Cantonal Hospital Dr. Safet Mujic Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041985
- Sponsor's protocol ID
- 1703016
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I am ready to share all IPD that underlie results in a publication
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.
PubMed 7604354Uehara 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.
PubMed 19558900Tanaka 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.
PubMed 29682354Benoist 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.
PubMed 12184430
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Diazepam After Whiplash
- ClinicalTrials.gov ID
- NCT05041985
- Acronym / sponsor ID
- 1703016
- Keywords
- whiplash, cervical spine, neck, whiplash injury, muscle spasm, diazepam, muscle strain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Edin MešanovićUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Study group will get the recommendation to use one Diazepam 5 mg pill per day (bedtime) for 7 days after whiplash injury.
| Arm | Type | Receives |
|---|---|---|
| group A (the Test group) | Experimental | Drug: Diazepam Tabletsarm which received Diazepam 5 mg therapy for 7 days after whiplash |
| group B (the control group) | No intervention | –a group which did not receive Diazepam 5 mg therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who suffered cervical spine injury caused by a traffic accident in the previous 48 hours
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazepam TabletsDiazepam 5 mg tablet once per day (bedtime) for 7 days | Drug | group A (the Test group) |
Primary outcome
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
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
5 secondary outcomes
changes in Visual Analog Scale scores 7 days after the injury (0-10; 0-no pain 10 maximum pain level)
Time frame: 7 days
changes in Visual Analog Scale scores 6 weeks after the injury (0-10; 0-no pain 10 maximum pain level)
Time frame: 6 weeks
changes in Visual Analog Scale scores 6 months after the injury (0-10; 0-no pain 10 maximum pain level)
Time frame: 6 months
change in Whiplash Disability Questionnaire score 6 weeks after injury (0-130; 0 no disability, 130 maximal disability)
Time frame: 6 weeks
change in Neck Disability Index score 6 weeks after injury (0-50, 0 - no disability 50 maximal disability)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 7604354Spitzer 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.
- Background: PubMed 19558900Uehara 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.
- Background: PubMed 29682354Tanaka 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.
- Background: PubMed 12184430Benoist 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.
- Individual participant dataSharing planned: Yes. I am ready to share all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diazepam Tablets in people with Whiplash Injuries and Whiplash Injury of Cervical Spine, run by Edin Mešanović at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Whiplash Disability Questionnaire score 6 months after injury (0-130; 0 no disability, 130 maximal disability) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041985, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.