Association Between Low Cortisol Levels and Whiplash Syndrome

NCT02090309 | Unknown Phase 2

• 1 other identifier: sor0237-13ctil
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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 From all patients a blood sample will be withdrawn to measure cortisol concentrations.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.

Conditions

Injuries, Whiplash

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Hydrocortisone injection

ACTIVE COMPARATOR

I.V Hydrocortisone 100 mg single bolus.

Drug: Hydrocortisone

normal saline

PLACEBO COMPARATOR

I.V normal saline 0.9% a single bolus of 5 ml.

Drug: normal saline 0.9%

Interventions

Hydrocortisone DRUG

100 mg IV (in the vein) injection as a single bolus of hydrocortisone for the study group.

Also known as: Cortisol

Hydrocortisone injection

normal saline 0.9% DRUG

IV injection of 5 ml normal saline 0.9% as a single bolus.

normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• victims of motor vehicle accidents
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (3)

Soroka Medical Center

Beersheba, Negev, 84101, Israel

RECRUITING

Soroka University Medical Center

Beersheba, Negev, 84101, Israel

RECRUITING

Soroka University Medical Center

Beersheba, Negev, 84101, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 38767196 DERIVED

• 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.

  PMID: 35141873 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.

  PMID: 31811333 DERIVED

MeSH Terms

Conditions

Whiplash Injuries

Interventions

Hydrocortisone; Saline Solution

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• David Czeiger, M.D. PhD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: March 18, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 28, 2014

Record last verified: 2014-01

Locations

IL (3)