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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 From all patients a blood sample will be withdrawn to measure cortisol concentrations.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.
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 From all the participants a volume of 5 milliliter of peripheral blood will be withdrawn for cortisol concentration determination prior to the study intervention.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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocortisone injection | Active Comparator | I.V Hydrocortisone 100 mg single bolus. |
|
| normal saline | Placebo Comparator | I.V normal saline 0.9% a single bolus of 5 ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone | Drug | 100 mg IV (in the vein) injection as a single bolus of hydrocortisone for the study group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Six months following the motor vehicle accident. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Czeiger, M.D. PhD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Recruiting | Beersheba | Negev | 84101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38767196 | Derived | Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2. | |
| 35141873 |
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| ID | Term |
|---|---|
| D014911 | Whiplash Injuries |
| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| normal saline 0.9% | Drug | IV injection of 5 ml normal saline 0.9% as a single bolus. |
|
| Soroka University Medical Center | Recruiting | Beersheba | Negev | 84101 | Israel |
|
| Soroka University Medical Center | Recruiting | Beersheba | Negev | 84101 | Israel |
|
| 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. |
| 31811333 | Derived | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |