Dexamethasone Therapy for Low Back Pain

NCT ID: NCT02965196

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone Therapy

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%).

Group Type ACTIVE_COMPARATOR

IV Dexamethasone Therapy

Intervention Type DRUG

Placebo Therapy

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.

Group Type PLACEBO_COMPARATOR

IV Normal Saline (NaCl 0.9%)

Intervention Type OTHER

Interventions

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IV Dexamethasone Therapy

Intervention Type DRUG

IV Normal Saline (NaCl 0.9%)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Itay Ophir, MD

Role: CONTACT

Phone: 972-543162177

Email: [email protected]

Facility Contacts

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Itay Ophir, MD

Role: primary

Other Identifiers

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HY-78-16

Identifier Type: -

Identifier Source: org_study_id