Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam

Istituto Ortopedico Rizzoli

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: Meloxicam; Other: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02706054

MELO-RCT

Details and patient eligibility

About

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

Full description

In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in a novel way, an IM administration near a nerve root.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

C-group

Placebo Comparator group

Description:

patients receiving an IM saline injection near the nerve root (periradicular)

Treatment:

Other: saline

M-group

Experimental group

Description:

patients receiving an IM Meloxicam injection near the nerve root (periradicular)

Treatment:

Drug: Meloxicam