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

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Other: saline; Drug: Meloxicam

• Registration Number: NCT02706054
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2014-07
• Study Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C-group	saline	patients receiving an IM saline injection near the nerve root (periradicular)
M-group	Meloxicam	patients receiving an IM Meloxicam injection near the nerve root (periradicular)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Istituto ortopedico Rizzoli; 🇮🇹 Bologna, Italy