Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain

Launched by FIDIA FARMACEUTICI S.P.A. · Oct 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Tricortin 1000 for people suffering from chronic low back pain. The goal is to see if Tricortin 1000 provides better pain relief compared to a placebo (a pill with no active ingredients) over a period of 15 days. To be eligible for the study, participants need to be between 40 and 70 years old, have had moderate to severe low back pain for at least three months, and have a body mass index (BMI) under 30. They also should not be taking other pain medications during the study and must agree to complete a daily diary about their pain.

Participants in this trial can expect to visit the study site multiple times, undergo assessments to confirm their low back pain, and receive either Tricortin 1000 or a placebo. It’s important for potential participants to know that they need to provide informed consent and meet specific health criteria to join the study. This trial is currently recruiting, and involvement may offer individuals a chance to help improve treatment options for chronic low back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical diagnosis of mechanical (mild, moderate degenerative process of disc and facet) chronic LBP, for at least 3 months but no more than 6 months, confirmed (thanks to instrumental analysis obtained within 9 months before the Screening visit) by CT or MRI. In case a MRI/CT performed in the previous 9 months is not available, the diagnosis should be confirmed by means of a MRI performed between Screening visit (Visit 1) and Baseline visit (Visit 2)
• • 2. A moderate to severe acute exacerbation of Chronic LBP at study entry, defined as a score ≥4 and ≤8 rated on the NRS-11
• • 3. Age greater than or equal to 40 and less than or equal to 70 years
• • 4. Patient able to maintain a Diary during the study
• • 5. Patient with a Body Mass Index (BMI) \< 30 kg/m2
• • 6. Discontinuation of any analgesic/NSAID therapy, opioids, corticosteroids, skeletal muscle relaxants and any other medication or non-pharmacological therapy (if it would interfere with the study assessments), with no intent to resume during study
• • 7. Patients who did not receive antidepressant medications and/or benzodiazepines for at least 60 days
• • 8. Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing and able to comply with the study requirements
• • 9. Patient has undergone the informed consent process and has signed an approved consent form
• • 10. If female, patient must have a negative urine pregnancy test and use a highly effective form of contraception for at least one month prior to screening and throughout the study; or females must be surgically sterile, or postmenopausal as documented in medical history for at least one year. Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence\*
• • 11. Patients who did not use Tricortin 1000 in the past to treat LBP or other pathological conditions.
• • Note: According to 4.1 paragraph "Birth control methods which may be considered as highly effective" of the CTFG/Recommendations related to contraception and pregnancy testing in clinical trials
• Baseline Inclusion Criteria:
• • 1. In aptients for which a MRI/CT performed in the previous 9 months is not available, the diagnosis of chronic LBP should be confirmed by means of a MRI performed between screening visit (Visit 1) and baseline (Visit 2)
• • 2. LBP with score ≥ 5 and ≤ 8 in the NRS-11 (off medication except for paracetamol, study rescue medication)
• • 3. Patient has discontinued use of all analgesic/NSAIDs, opioids, corticosteroids, skeletal muscle relaxants, and any other medication or non-pharmacological therapy (if it would interfere with the study assessments) at V1 (except for patients that will perform the MRI between Screening and Baseline visit) and agree not to resume them during study (except for paracetamol, study rescue medication). These medication must be discontinued for at least 14 days before the Baseline visit (Visit 2/ Day 0), i.e. can be taken for maximum 7 days during the 14-21 days of Screening phase, in case that the screening phase is prolonged up to 21 days in patients that will perform the MRI between screening and baseline visit.
• • 4. Patient has complied with the requirements for rescue medication (no more than 4 tablets - 2 grams - of paracetamol per day up to 4 days per week) and no paracetamol intake in the 24 hours before baseline visit
• • 5. Patient continues to meet all Screening inclusion/exclusion criteria at the Baseline visit, with the exception of screening inclusion criterion 2 which is replaced by baseline inclusion criterion 2
• Exclusion Criteria:
• • Related to patients
• • 1. Patients suffering of chronic non-specific LBP
• • 2. Females who are pregnant or breast-feeding
• • 3. Patients who are not able to give informed consent
• • 4. Patients who cannot commit to the entire duration of the study
• • 5. Patients with back pain referred from a mechanical cause (except for mild, moderate degenerative process of disc and facet) non spinal source or back pain associated with another specific spinal cause
• • 6. Patients who have a primary bone disease, cancer, infection (except for osteoporosis patients without fracture history)
• • 7. Other conditions which may confound the interpretation of the study, such as carpal, rheumatoid arthritis, severe venous diseases, peripheral arterial diseases, transient ischemic attack, stroke, current symptoms of coronary artery disease
• • 8. History of narcotic abuse at any time in the past and/or drug or alcohol abuse in the past year
• • 9. Patients who have had a previous treatment with physical therapy for LBP in the last 4 weeks before the screening visit or are going through a course of physical therapy or chiropractic treatment at the time of planned enrolment
• • 10. Participation in another research study
• • 11. History of epilepsy
• • 12. Patients who have an unstable psychiatric condition
• Red flags as possible indicators of serious spinal pathology:
• • 13. Unexplained serious thoracic pain
• • 14. Any recent trauma, which may raise the possibility of a fracture
• • 15. Fever and unexplained weight loss
• • 16. Bladder or bowel dysfunction
• • 17. History of carcinoma
• • 18. Progressive neurological deficit
• • 19. Disturbed gait, saddle anaesthesia Musculoskeletal related
• • 20. Radicular syndromes of idiopathic,metabolic, toxic, infective, demyelinating or neoplastic aetiology
• • 21. Patients with spondylolisthesis, spondylolysis or ankylosing spondylitis.
• • 22. Patients with scoliosis of 15° or more
• • 23. Patients with inflammatory arthritis or severe degenerative process of disc and facet
• • 24. Patients who have had prior spine surgery, including rhizotomy as like as, patients who are planning or have been advised to have spine surgery.
• • Concomitant conditions, diseases, medications and/or clinical history
• • 25. Patients with any concomitant chronic disease(s) or condition(s) that may predispose them to a high probability of interfering with the completion of the follow-up of the study such as peptic ulcer, liver disease, severe coronary disease, renal disease, cancer, pregnancy, alcoholism, mental state, or other clinically significant condition
• • 26. Patients with history of active or suspected oesophageal, gastric, pyloric channel, or duodenal ulceration or bleeding in the last 12 weeks before the screening visit
• • 27. Patients requiring chronic use of analgesia for pain
• • 28. Patients with known allergies or hypersensitivity or intolerance to Tricortin 1000, NSAIDs and/or paracetamol, and/or to active or inactive excipients of formulation
• • 29. Patients in treatment with neuroleptics (antipsychotics)
• • 30. Patients affected by diabetic neuropathy, multiple sclerosis or Amyotrophic Lateral Sclerosis
• • 31. Any contraindications to either prone distraction or side posture manipulation
• • 32. Any contraindications as reported in the Patient Information Leaflet of Tricortin 1000 or Diclofenac sodium medicated plaster.