An Open Label, Randomized-controlled Trial to Assess Efficacy Safety of HYALODISC With Physical Exercise Program

Launched by FIDIA FARMACEUTICI S.P.A. · Feb 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called HYALODISC, which is an injection given directly into the spine, combined with a physical exercise program, to see if it helps people with chronic low back pain caused by degenerative disc disease. Participants will be randomly assigned to one of two groups: one will receive the injection along with the exercise program, while the other will only follow the exercise program. The goal is to find out if the injection makes a significant difference in pain relief and overall function compared to just exercising.

To be eligible for this study, participants must be between 18 and 70 years old, have been experiencing low back pain for at least three months, and have specific findings on an MRI scan related to their condition. During the trial, participants will take part in 18 supervised physiotherapy sessions over 12 weeks, along with home exercises. Importantly, those who join should avoid certain activities, like jogging or lifting heavy weights, for 48 hours after the injection. This trial is currently recruiting, and it aims to provide valuable information about potential new treatment options for managing low back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients aged 18-70 years;
• • 2. Written informed consent;
• • 3. Willing and able to comply with the protocol for the duration of the study;
• • 4. Chronic low back pain for at least 3 months from the screening;
• • 5. Patients with at least one lumbar (L1-S1) black disc (Pfirrmann grade III-V) seen on magnetic resonance imaging (MRI) examination (MRI performed within 4 months from the screening visit);
• • 6. Low back pain score of at least 5 on a 0-10 NRS at screening;
• • 7. Roland-Morris Disability Questionnaire score of at least 9 on the 24-point questionnaire at screening;
• • 8. If female of childbearing potential, must have a negative pregnancy test at screening and agree to use a reliable form of contraception throughout the study\*.
• • Note: To be considered of non-childbearing potential, females must be surgically sterile or postmenopausal for at least 1 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..
• Exclusion Criteria:
• • 1. Cauda equina syndrome;
• • 2. Active malignancy or tumours as source of symptoms;
• • 3. Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection;
• • 4. Previous lumbar spine surgery;
• • 5. Evidence of prior lumbar vertebral body fracture;
• • 6. Patients with radiculopathy caused by nerve root compression;
• • 7. Verbiest Syndrome of Lumbar Spine;
• • 8. Spondylolisthesis (\> Grade 1) with or without spondylolysis at the symptomatic level(s);
• • 9. Radiological sacroiliac joint involvement;
• • 10. Patients with positive response to medial branch block;
• • 11. Patients that did physical exercise therapy in the last three months before screening;
• • 12. For patients that need to perform a MRI at the screening visit, contraindications to perform the MRI, such as patients carrying cerebral clips or cooling, valvular endoprosthesis with metal components, defibrillators, pacemakers or neurostimulant devices;
• • 13. Sacrum-iliac synchondrosis agenesis seen on MRI;
• 14. Patients with symptomatic hernia, sciatica or spinal cord injury:
• • 15. Significant systemic disease, including unstable angina, autoimmune disease, rheumatoid arthritis, and muscular dystrophy;
• • 16. Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications; or undergoing radiation therapy;
• • 17. Patients with known allergies, hypersensitivity or intolerance to paracetamol and/or active or inactive excipients of formulation;
• • 18. Ongoing or previous participation in another drug or device clinical study within the previous 2 months from the screening;
• • 19. Females known to be pregnant or nursing at time of enrolment or with plans to become pregnant within the planned length of follow-up or unwilling to use adequate contraception and conduct a pregnancy test at screening;
• • 20. Patients with suspected or known history of hypersensitivity to hyaluronic acid or to hyaluronate preparations or gram-positive bacterial proteins;
• • 21. Patients unable to provide a valid informed consent or those acting in an emergency situation..