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Association Between Low Cortisol Levels and Whiplash Syndrome

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ClinicalTrials.gov Identifier: NCT02090309
Recruitment Status : Unknown
Verified January 2014 by Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : March 18, 2014
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center

Brief Summary:
The investigators hypothesis is that low (or low relatively to the situation) cortisol levels might be a causative factor of whiplash injury or post traumatic stress disorder following road accidents. In this study the investigators enroll patients who sustained a road accident. From all patients a blood sample will be withdrawn to measure cortisol concentrations. Than, the patients will be divided into 2 groups: the study group will receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid used routinely for many years). The control group will receive a same volume of normal saline which would be used as a placebo treatment. The investigators assume that patients with low cortisol levels would tend to have a higher incidence of whiplash injuries and / or post traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these untoward sequelas of trauma.

Condition or disease Intervention/treatment Phase
Injuries, Whiplash Drug: Hydrocortisone Drug: normal saline 0.9% Phase 2

Detailed Description:

Study protocol Patients arriving during day time (08:00 - 16:00) to the Soroka Hospital emergency department following a motor vehicle accident and will be found eligible will be asked to participate in the study. Following an informed consent the recruited patients will be randomly divided into a study group or a control group. From all the participants a volume of 5 milliliter of peripheral blood will be withdrawn for cortisol concentration determination prior to the study intervention. After withdrawing the blood sample patients will receive a single bolus of intravenous Hydrocortisone 100 milligram (study group) or normal saline (0.9%) at a similar volume to that of the study drug, 5 ml (control group). Patients will be otherwise receiving the regular management of a trauma patient. The enrolled patients will fill simple, short questionnaires including demographic data, neck disability index, (NDI), numeric pain rating scale (NPRS), Tampa scale for kinesiophobia (TSK-11), PTSD questionnaire (PDA), and will be assessed by the treating physician for the degree of whiplash (WAD 0-4).

The patients will be followed-up by one of the investigators for a period of 6 months. In each visit the patient will be assessed again by the above mention tools.

Sample size: 45 patients in each arm. Blinding and randomization: triple blinding and using a randomization software. Statistical assessment will be performed to identify differences of developing WAD (whiplash associated disorder) between patients who had an admission low level of cortisol compared with those who had a high or normal level, and also between patients who received hydrocortisone compared to those who received placebo.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Association Between Low Cortisol Level and Whiplash Syndrome and the Effect of a Single Hydrocortisone Injection on Neck Symptoms Among Motor Vehicle Accident Victims: a Randomized Placebo Controlled Double Blinded Study
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016


Arm Intervention/treatment
Active Comparator: Hydrocortisone injection
I.V Hydrocortisone 100 mg single bolus.
Drug: Hydrocortisone
100 mg IV (in the vein) injection as a single bolus of hydrocortisone for the study group.
Other Name: Cortisol

Placebo Comparator: normal saline
I.V normal saline 0.9% a single bolus of 5 ml.
Drug: normal saline 0.9%
IV injection of 5 ml normal saline 0.9% as a single bolus.




Primary Outcome Measures :
  1. Prevention of whiplash syndrome according to validated scales of pain and neck motion disability. [ Time Frame: Six months following the motor vehicle accident. ]
    Accomplishment of the primary outcome is measured by a composite of several variables. The following indices will be used to measure the primary outcome among the enrolled patients: neck disability index, numeric pain rating scale, Tampa scale for kinesiophobia, PTSD questionnaire (PDA), and will be assessed by the treating physician for the degree of whiplash (0-4).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • victims of motor vehicle accidents
  • signed informed consent

Exclusion Criteria:

  • pregnancy
  • traumatic brain injury
  • psychiatry disorders
  • active cancerous conditions
  • adrenal diseases
  • medical treatment by estrogens, anti-depressants, melatonin, pain control.
  • substance abuse
  • hospitalization due to the trauma
  • contra indication to hydrocortisone treatment
  • over 6 hours from time of injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090309


Locations
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Israel
Soroka Medical Center Recruiting
Beer Sheva, Negev, Israel, 84101
Contact: David Czeiger, M.D       czeiger@bgu.ac.il   
Sub-Investigator: Gad Shaked, M.D.         
Soroka University Medical Center Recruiting
Beer Sheva, Negev, Israel, 84101
Contact: Gad Shaked, M.D    972542365600    shakedg@bgu.ac.il   
Contact: David Czeiger, M.D    972544761408    czeiger@bgu.ac.il   
Sub-Investigator: Gad Shaked         
Soroka University Medical Center Recruiting
Beer Sheva, Negev, Israel, 84101
Contact: David Czeiger, M.D.       czeiger@bgu.ac.il   
Sub-Investigator: Gad Shaked         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: David Czeiger, M.D. PhD Soroka University Medical Center

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Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02090309     History of Changes
Other Study ID Numbers: sor0237-13ctil
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Whiplash Injuries
Neck Injuries
Wounds and Injuries
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents