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

NCT02706054 | Completed Phase 3

• 1 other identifier: MELO-RCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (1)

• 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

Study Arms (2)

C-group

PLACEBO COMPARATOR

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

Other: saline

M-group

EXPERIMENTAL

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

Drug: Meloxicam

Interventions

saline OTHER

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

C-group

Meloxicam DRUG

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

Also known as: mobic

M-group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain from 6 months or less
• older than 18 years

You may not qualify if:

• not able to understand and sign the written informed consent

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (2)

• Borghi B, Aurini L, White PF, Mordenti A, Lolli F, Borghi R, Martignani M, Greggi T. Long-lasting beneficial effects of periradicular injection of meloxicam for treating chronic low back pain and sciatica. Minerva Anestesiol. 2013 Apr;79(4):370-8. Epub 2013 Jan 10.

  PMID: 23306395 BACKGROUND

• Aurini L, Borghi B, White PF, TOGNu A, Rossi B, Fini G, Fusco P, Mosca M, Borghi R. Treatment of chronic cervicobrachial pain with periradicular injection of meloxicam. Minerva Anestesiol. 2016 Apr;82(4):411-8. Epub 2015 Sep 3.

  PMID: 26337371 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Sodium Chloride; Meloxicam

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• battista borghi, MD, Prof

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: March 11, 2016
• Study Start: May 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 12, 2023

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)