Back to resultsTreatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
saline
Meloxicam
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility 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
Sites / Locations
- Istituto ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
C-group
M-group
Arm Description
patients receiving an IM saline injection near the nerve root (periradicular)
patients receiving an IM Meloxicam injection near the nerve root (periradicular)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire
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)
Full Information
NCT ID
NCT02706054
First Posted
February 3, 2016
Last Updated
May 11, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT02706054
Brief Title
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam
Official Title
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C-group
Arm Type
Placebo Comparator
Arm Description
patients receiving an IM saline injection near the nerve root (periradicular)
Arm Title
M-group
Arm Type
Experimental
Arm Description
patients receiving an IM Meloxicam injection near the nerve root (periradicular)
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
The patients received an IM injection of saline near the nerve root (periradicular)
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Other Intervention Name(s)
mobic
Intervention Description
The patients received an IM injection of meloxicam near the nerve root (periradicular)
Primary Outcome Measure Information:
Title
Change from baseline NRS pain scale score at different consecutive follow up assessments
Description
Patients reported a numeric value to evaluate pain (0= no pain, 10= wrost pain)
Time Frame
5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days
Secondary Outcome Measure Information:
Title
Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire
Description
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)
Time Frame
5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
battista borghi, MD, Prof
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23306395
Citation
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.
Results Reference
background
PubMed Identifier
26337371
Citation
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.
Results Reference
background
Learn more about this trial
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam
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