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NCT02965196 Clinical Trial

Dexamethasone Therapy for Low Back Pain

Low Back Pain Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02965196
Other study ID # HY-78-16
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 13, 2016
Last updated November 13, 2016
Start date December 2016
Est. completion date March 2017

Study information
Verified date November 2016
Source Hillel Yaffe Medical Center
Contact Itay Ophir, MD
Phone 972-543162177
Email ophir.itay@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• IV Dexamethasone Therapy

Other:
• IV Normal Saline (NaCl 0.9%)

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Reduction Pain will be measured according to the Visual Analog Scale throughout the treatment. Four days No
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