Efficacy of a fixed combination of diclofenac 75 mg + thiocolchicoside 4 mg as solution for injection, in relieving back pain symptoms. Controlled study vs. diclofenac 75 mg solution for injection and placebo. RELIEF Study

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• 1. Patients with symptoms that might be attributable to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at inclusion and in the 48 hours preceding the inclusion in the study or contact with subjects positive to SARS-CoV-2 in the 48 hours preceding the inclusion in the study; 2. Patients with a history of cervical, thoracic, or lumbosacral pain for ≥ 50% of the time in the year prior to screening; 3. Patients with presence of lumbosciatalgia; 4. Patients with a history of any LBP episode, except the current acute episode, within 3 months prior to screening that was associated with disability, or required treatment with an opioid analgesic; 5. Patients with acute LBP caused by a serious or malignant condition; 6. Patients with acute LBP of traumatic origin; 7. Patients with acute LBP of infective origin; 8. Patients with acute LBP caused by a rheumatic disease; 9. Patients on treatment with anticoagulant agents; 10. Patients who underwent spinal surgery in the year prior to screening or had a history of more than one spinal surgery; 11. Patients who had a history of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis; 12. Patients with a medical history of seizures; 13. Pregnancy or lactation period; 14. Women with childbearing potential who are not using highly effective methods of birth control to avoid pregnancy and who are not willing to use highly effective methods of birth control until one month after the end of the treatment; 15. Women with polymenorrhea; 16. History of alcohol or drug abuse; 17. History of allergy or hypersensitivity or intolerance to diclofenac or thiocolchicoside, and/or to active or inactive excipients of the used IMPs formulations; 18. Known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs); 19. Use of non-steroid anti-inflammatory drugs (e.g. acetyl salicylic acid) and analgesics (with the exception of diclofenac) in the week before the entry in the study. Chronic intake of small doses of acetylsalicylic acid (≤ 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study; 20. Use of diclofenac in the 12 hours preceding entry in the study; 21. Use of any other treatment or medication that can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis) in the week before the entry in the study; 22. Use of diuretic agents in the 30 days preceding entry in the study; 23. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening; 24. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results. In particular, patients with any of the following diseases should be excluded from participation: overt congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and/or cerebral vascular disease, severe liver or renal impairment, alterations of haematopoiesis; 25. Patients in which the administration of the IMP is contraindicated, such as in case of flaccid paralysis and muscular hypotonia; 26. Participation in any other clinical study or investigation within 30 days prior to the screening or use of any investigational product within a period of more than 5 half-lives, whichever is longer.
• 27. Males who are not willing to use effective methods of birth control until three months after the end of treatment.