Clinical trial

Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study

Name

MELO-RCT

Description

This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation

Trial arms

Trial start

2012-05-01

Estimated PCD

2014-07-01

Trial end

2015-12-01

Status

Completed

Phase

Early phase I

Treatment

saline

The patients received an IM injection of saline near the nerve root (periradicular)

Arms:

C-group

Meloxicam

The patients received an IM injection of meloxicam near the nerve root (periradicular)

Arms:

M-group

Other names:

mobic

Size

Primary endpoint

Change from baseline NRS pain scale score at different consecutive follow up assessments

5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days

Eligibility criteria

Inclusion Criteria: * low back pain from 6 months or less * older than 18 years Exclusion Criteria: * not able to understand and sign the written informed consent

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

Updated at

2023-05-12

1 organization

1 product

1 indication

Organization

Istituto Ortopedico Rizzoli

Product

Meloxicam

Indication

Low Back Pain