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Completed

NCT Number: NCT02706054

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

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Istituto ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Other

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

Meloxicam

Drug

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

Other names: mobic

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 11, 2016
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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