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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-group | Placebo Comparator | patients receiving an IM saline injection near the nerve root (periradicular) |
|
| M-group | Experimental | patients receiving an IM Meloxicam injection near the nerve root (periradicular) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saline | Other | The patients received an IM injection of saline near the nerve root (periradicular) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| battista borghi, MD, Prof | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23306395 | Background | 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. | |
| 26337371 | Background | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Meloxicam | Drug | The patients received an IM injection of meloxicam near the nerve root (periradicular) |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |