Association Between Low Cortisol Levels and Whiplash Syndrome

Sponsor

Soroka University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02090309

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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 From all patients a blood sample will be withdrawn to measure cortisol concentrations.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 From all the participants a volume of 5 milliliter of peripheral blood will be withdrawn for cortisol concentration determination prior to the study intervention.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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Prevention of whiplash syndrome according to validated scales of pain and neck motion disability. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soroka Medical Center	Beer Sheva	Negev	Israel	84101
2	Soroka University Medical Center	Beer Sheva	Negev	Israel	84101
3	Soroka University Medical Center	Beer Sheva	Negev	Israel	84101

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator: David Czeiger, M.D. PhD, Soroka University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Soroka University Medical Center

ClinicalTrials.gov Identifier:

NCT02090309

Other Study ID Numbers:

sor0237-13ctil

First Posted:

Mar 18, 2014

Last Update Posted:

Aug 28, 2014

Last Verified:

Jan 1, 2014

Additional relevant MeSH terms:

Whiplash Injuries

Hydrocortisone

Study Results

No Results Posted as of Aug 28, 2014