Dexamethasone Therapy for Low Back Pain

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: IV Normal Saline (NaCl 0.9%); Drug: IV Dexamethasone Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02965196

HY-78-16

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Dexamethasone Therapy

Active Comparator group

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%).

Treatment:

Drug: IV Dexamethasone Therapy

Placebo Therapy

Placebo Comparator group

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.

Treatment:

Other: IV Normal Saline (NaCl 0.9%)