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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

PAES, double blind, double dummy, multicenter, randomized, controlled clinical study to demonstrate superiority of Tricortin 1000 over placebo in improvement in pain relief as change from baseline to 15 days in patients with chronic low back pain (LBP).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fidia Farmaceutici s.p.a.
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

1. Clinical diagnosis of mechanical (mild, moderate degenerative process of disc and facet) LBP, for at least 3 months but no more than 6 months, confirmed (thanks to instrumental analysis obtained within 6 months before the Screening visit) by CT or MRI

2. A moderate to severe Chronic LBP, 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. LBP with score > 5 and ≤ 8 in the NRS-11 (off medication except for paracetamol, study rescue medication)

2. 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 and agree not to resume them during study (except for paracetamol, study rescue medication).

3. 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

4. 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 1

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

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.