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

May 11, 2023 updated by: Istituto Ortopedico Rizzoli

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: C-group
patients receiving an IM saline injection near the nerve root (periradicular)
Other: saline
The patients received an IM injection of saline near the nerve root (periradicular)
Experimental: M-group
patients receiving an IM Meloxicam injection near the nerve root (periradicular)
Drug: Meloxicam
The patients received an IM injection of meloxicam near the nerve root (periradicular)
Other Names:
  • mobic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline NRS pain scale score at different consecutive follow up assessments
Time Frame: 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)
5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: battista borghi, MD, Prof, Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MELO-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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