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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

Tracking Information
First Submitted Date  ICMJE February 11, 2014
First Posted Date  ICMJE March 18, 2014
Last Update Posted Date August 28, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02090309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Association Between Low Cortisol Levels and Whiplash Syndrome
Official Title  ICMJE 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
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 From all patients a blood sample will be withdrawn to measure cortisol concentrations.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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Injuries, Whiplash
Intervention  ICMJE
  • Drug: Hydrocortisone
    100 mg IV (in the vein) injection as a single bolus of hydrocortisone for the study group.
    Other Name: Cortisol
  • Drug: normal saline 0.9%
    IV injection of 5 ml normal saline 0.9% as a single bolus.
Study Arms  ICMJE
  • Active Comparator: Hydrocortisone injection
    I.V Hydrocortisone 100 mg single bolus.
    Intervention: Drug: Hydrocortisone
  • Placebo Comparator: normal saline
    I.V normal saline 0.9% a single bolus of 5 ml.
    Intervention: Drug: normal saline 0.9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 16, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02090309
Other Study ID Numbers  ICMJE sor0237-13ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soroka University Medical Center
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Czeiger, M.D. PhD Soroka University Medical Center
PRS Account Soroka University Medical Center
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP