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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02706054

Enrollment

Registered

2016-03-11

Start date

2012-05-31

Completion date

2015-12-31

Last updated

2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Brief summary

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

Detailed 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.

Interventions

OTHERsaline

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

DRUGMeloxicam

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire	5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days	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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026