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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A (the Test group) | Experimental | arm 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam Tablets | Drug | Diazepam 5 mg tablet once per day (bedtime) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| changes in Visual Analog Scale scores 6 weeks after the injury (0-10; 0-no pain 10 maximum pain level) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KB "dr.Safet Mujic" | Mostar | HNK | 88000 | Bosnia and Herzegovina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7604354 | Background | 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. | |
| 19558900 | Background | 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. |
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I am ready to share all IPD that underlie results in a publication
I would be ready to share the IPD after publication.
I would like to be included in process of who is getting the IPD.
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| ID | Term |
|---|---|
| D014911 | Whiplash Injuries |
| D013035 | Spasm |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| D014947 | Wounds and Injuries |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Study group will get the recommendation to use one Diazepam 5 mg pill per day (bedtime) for 7 days after whiplash injury.
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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.
Comparation of same score at the initial examination after the injury |
| 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 | 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 | 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 | 6 weeks |
| 29682354 | Background | 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. |
| 12184430 | Background | 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. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |