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Dexamethasone Therapy for Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IV Dexamethasone Therapy
IV Normal Saline (NaCl 0.9%)
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • No "red flags" of serious spinal pathology
  • Normal neurological examination
  • Indication for opioid analgesia based on our pain management protocol
  • No known hypersensitivity to the medication
  • Ability to provide informed consent

Exclusion Criteria:

  • Pregnancy
  • All others who do not meet inclusion criteria

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone Therapy

Placebo Therapy

Arm Description

Three consecutive doses of IV Dexamethasone with be administered over three days. The doses will be tapered according to the following: 1st dose, 26mg., 2nd dose, 20mg., and the third dose will be 10 mg. Each dose will be administered over 24 hours in a slow drip, in a 100cc. normal saline bag (0.9%).

Three consecutive doses of 100cc IV normal saline (0.9%), will be administered over three days. Each dose will be administered over 24 hours in a slow drip.

Outcomes

Primary Outcome Measures

Pain Reduction
Pain will be measured according to the Visual Analog Scale throughout the treatment.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2016
Last Updated
November 13, 2016
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02965196
Brief Title
Dexamethasone Therapy for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will evaluate the efficacy of IV Dexamethasone in treatment low back pain as an adjunct to analgesics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone Therapy
Arm Type
Active Comparator
Arm Description
Three consecutive doses of IV Dexamethasone with be administered over three days. The doses will be tapered according to the following: 1st dose, 26mg., 2nd dose, 20mg., and the third dose will be 10 mg. Each dose will be administered over 24 hours in a slow drip, in a 100cc. normal saline bag (0.9%).
Arm Title
Placebo Therapy
Arm Type
Placebo Comparator
Arm Description
Three consecutive doses of 100cc IV normal saline (0.9%), will be administered over three days. Each dose will be administered over 24 hours in a slow drip.
Intervention Type
Drug
Intervention Name(s)
IV Dexamethasone Therapy
Intervention Type
Other
Intervention Name(s)
IV Normal Saline (NaCl 0.9%)
Primary Outcome Measure Information:
Title
Pain Reduction
Description
Pain will be measured according to the Visual Analog Scale throughout the treatment.
Time Frame
Four days

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: No "red flags" of serious spinal pathology Normal neurological examination Indication for opioid analgesia based on our pain management protocol No known hypersensitivity to the medication Ability to provide informed consent Exclusion Criteria: Pregnancy All others who do not meet inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Itay Ophir, MD
Phone
972-543162177
Email
ophir.itay@gmail.com
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itay Ophir, MD
Email
ophir.itay@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dexamethasone Therapy for Low Back Pain

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