Association Between Low Cortisol Levels and Whiplash Syndrome
Primary Purpose
Injuries, Whiplash
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Hydrocortisone
normal saline 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Injuries, Whiplash
Eligibility 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
Sites / Locations
- Soroka Medical CenterRecruiting
- Soroka University Medical CenterRecruiting
- Soroka University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hydrocortisone injection
normal saline
Arm Description
I.V Hydrocortisone 100 mg single bolus.
I.V normal saline 0.9% a single bolus of 5 ml.
Outcomes
Primary Outcome Measures
Prevention of whiplash syndrome according to validated scales of pain and neck motion disability.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02090309
First Posted
February 11, 2014
Last Updated
August 27, 2014
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02090309
Brief Title
Association Between Low Cortisol Levels and Whiplash Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Whiplash
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrocortisone injection
Arm Type
Active Comparator
Arm Description
I.V Hydrocortisone 100 mg single bolus.
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
I.V normal saline 0.9% a single bolus of 5 ml.
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
Cortisol
Intervention Description
100 mg IV (in the vein) injection as a single bolus of hydrocortisone for the study group.
Intervention Type
Drug
Intervention Name(s)
normal saline 0.9%
Intervention Description
IV injection of 5 ml normal saline 0.9% as a single bolus.
Primary Outcome Measure Information:
Title
Prevention of whiplash syndrome according to validated scales of pain and neck motion disability.
Description
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).
Time Frame
Six months following the motor vehicle accident.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Czeiger, M.D. PhD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer Sheva
State/Province
Negev
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Czeiger, M.D
Email
czeiger@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Gad Shaked, M.D.
Facility Name
Soroka University Medical Center
City
Beer Sheva
State/Province
Negev
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gad Shaked, M.D
Phone
972542365600
Email
shakedg@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
David Czeiger, M.D
Phone
972544761408
Email
czeiger@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Gad Shaked
Facility Name
Soroka University Medical Center
City
Beer Sheva
State/Province
Negev
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Czeiger, M.D.
Email
czeiger@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Gad Shaked
12. IPD Sharing Statement
Citations:
PubMed Identifier
35141873
Citation
Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
Results Reference
derived
PubMed Identifier
31811333
Citation
Shaked G, Shaked D, Sebbag G, Czeiger D. The effect of steroid treatment on whiplash associated syndrome: a controlled randomized prospective trial. Eur J Trauma Emerg Surg. 2021 Aug;47(4):1115-1122. doi: 10.1007/s00068-019-01282-3. Epub 2019 Dec 6.
Results Reference
derived
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Association Between Low Cortisol Levels and Whiplash Syndrome
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