NCT02965196

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 13, 2016

Last Update Submit

November 13, 2016

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Reduction

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

    Four days

Study Arms (2)

Dexamethasone Therapy

ACTIVE COMPARATOR

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%).

Drug: IV Dexamethasone Therapy

Placebo Therapy

PLACEBO COMPARATOR

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.

Other: IV Normal Saline (NaCl 0.9%)

Interventions

IV Dexamethasone TherapyDRUG
Dexamethasone Therapy
IV Normal Saline (NaCl 0.9%)OTHER
Placebo Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Saline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Itay Ophir, MD

CONTACT

972-543162177ophir.itay@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2016

First Posted

November 16, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)