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

NCT ID: NCT02706054

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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C-group

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

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

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

M-group

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

Group Type EXPERIMENTAL

Meloxicam

Intervention Type DRUG

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

Interventions

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saline

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

Intervention Type OTHER

Meloxicam

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

Intervention Type DRUG

Other Intervention Names

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mobic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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battista borghi, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 23306395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26337371 (View on PubMed)

Other Identifiers

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MELO-RCT

Identifier Type: -

Identifier Source: org_study_id

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