Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02706054
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Low Back Pain Other: saline Drug: Meloxicam Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study
Study Start Date : May 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Meloxicam

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 Name: mobic




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706054


Locations
Layout table for location information
Italy
Istituto ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Layout table for investigator information
Principal Investigator: battista borghi, MD, Prof Istituto Ortopedico Rizzoli

Publications:
Layout table for additonal information
Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02706054     History of Changes
Other Study ID Numbers: MELO-RCT
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action