Injection of HYALODISC combined with exercise for low back pain relief

An Open Label, Randomized-controlled Trial to Assess Efficacy and Safety of HYALODISC Combined With Physical Exercise Program (PEP) Compared to Standard Care PEP in Patients With Low Back Pain Due to Degenerative Disc Disease

This study is testing if adding a special injection to a physical exercise program can help people with low back pain feel better compared to just doing the exercises alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fidia Farmaceutici s.p.a. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 2 sites (Cagliari and 1 other locations)
• Trial ID: NCT04757038 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of a single X-ray-guided intradiscal injection of HYALODISC, combined with a physical exercise program (PEP), compared to PEP alone in patients suffering from low back pain due to degenerative disc disease. Participants will be randomly assigned to receive either the injection along with PEP or PEP alone, with follow-up assessments at 4, 12, and 24 weeks. The study will include a total of 18 physiotherapy sessions for both groups, with specific instructions for home exercises. The trial seeks to determine if the addition of HYALODISC enhances pain relief and functional improvement.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with chronic low back pain and specific MRI findings indicating degenerative disc disease.

Not a fit: Patients with acute low back pain or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant pain relief and improved function for patients with degenerative disc disease.

How similar studies have performed: Other studies have shown promising results with similar injection therapies for low back pain, suggesting potential efficacy for this approach.

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..

Where this trial is running

Cagliari and 1 other locations

• Unità operativa complessa di Radiologia PO.SS.Trinità — Cagliari, Italy (Recruiting)
• Centro per la Terapia del Dolore NSI-EOC FMH Anestesiologia S.S.I.P.M.. Ospedale — Viganello, Lugano, Switzerland (Recruiting)

Study contacts

• Principal investigator: Stefano Marcia — Presidio Ospedaliero SS Trinità Cagliari
• Study coordinator: Nicola Giordan

Conditions Degenerative Disc Disease