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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706054
• Other study ID #: MELO-RCT
• Status: Completed
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Drug:
• Meloxicam
The patients received an IM injection of meloxicam near the nerve root (periradicular)

Locations

Country	Name	City	State
Italy	Istituto ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days
Secondary	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)	5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days