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

Istituto Ortopedico Rizzoli80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Low Back Pain

Interventions

salineOTHER

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

MeloxicamDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto ortopedico Rizzoli

Bologna, Italy

Outcomes

Primary Outcomes

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

Patients reported a numeric value to evaluate pain (0= no pain, 10= wrost pain)

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

Secondary Outcomes

Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire

pain-related insomnia, physical assistance, sport activities, work absence were assessed using a structured questionnaire with dichotomous items (yes/no presence of impairment to the selected item)

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

Data from ClinicalTrials.gov

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