Dexamethasone Therapy for Low Back Pain

Not Applicable

• Conditions: Low Back Pain
• Interventions: Drug: IV Dexamethasone Therapy; Other: IV Normal Saline (NaCl 0.9%)

• Registration Number: NCT02965196
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-13
• Study First Submitted QC: 2016-11-13
• Last Update Submitted: 2016-11-13
• Study First Posted: 2016-11-16
• Last Update Posted: 2016-11-16
• Study Start: 2016-12
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone Therapy	IV 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%).
Placebo Therapy	IV Normal Saline (NaCl 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.

Primary Outcome Measures

Name	Time	Method
Pain Reduction	Four days	Pain will be measured according to the Visual Analog Scale throughout the treatment.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel