Clinical Efficacy of Diazepam After Whiplash

NCT05041985 | Completed Phase 4

• 1 other identifier: 1703016
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injuries; Whiplash Injury of Cervical Spine

Keywords

whiplash; cervical spine; neck; whiplash injury; muscle spasm; diazepam; muscle strain

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

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

  7 days

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

  6 weeks

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

  6 months

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

  6 weeks

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

  6 weeks

Study Arms (2)

group A (the Test group)

EXPERIMENTAL

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

Drug: Diazepam Tablets

group B (the control group)

NO INTERVENTION

a group which did not receive Diazepam 5 mg therapy

Interventions

Diazepam Tablets DRUG

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

group A (the Test group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who suffered cervical spine injury caused by a traffic accident in the previous 48 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Edin Mešanović: lead

Study Sites (1)

KB "dr.Safet Mujic"

Mostar, HNK, 88000, Bosnia and Herzegovina

Location

Related Publications (4)

• 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.

  PMID: 7604354 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.

  PMID: 19558900 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.

  PMID: 29682354 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.

  PMID: 12184430 BACKGROUND

MeSH Terms

Conditions

Whiplash Injuries; Spasm; Sprains and Strains

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: orthopedic surgeon

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

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 13, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 4, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: I would be ready to share the IPD after publication.
• Access Criteria: I would like to be included in process of who is getting the IPD.

Locations

BO (1)