The objective of this study is to determine if one single X-ray-guided intradiscal injection of 8 mg/mL of HYALODISC combined with PEP will be more effective than only physical exercise program in patients with LBP from degenerative disc disease.
Enrolled patients will be randomly assigned to one of the two treatment groups below:
* Group 1: One single X-ray-guided intradiscal injection (25 gauge) of 8 mg/mL of HYALODISC combined with PEP. The investigator will use one syringe for each involved disc, up to a maximum of three discs.
* Group 2: PEP alone. The injection will be administered at V1 baseline (day 0). Any physical activity (e.g. jogging, tennis, weightlifting, prolonged upright position) in the 48 hours following the injection should be avoided.
Both groups (Group 1 and Group 2) will be treated with PEP according to a standardized protocol. Starting one week after the baseline visit (V1), patients will be prescribed of 18 physiotherapy sessions that will take place under supervision of physiotherapist twice a week in the first seven weeks (weeks 2-8) and once a week in the next four weeks (weeks 9-12). Twelve repetitions of each exercise for 3 sets will be performed during PEP session. Moreover, in addition to the 18 sessions performed with supervision of the physiotherapist, all patients will be instructed how to do exercises at home and will be asked to continue these exercises once a week in the first seven weeks (weeks 2-8) and twice a week in the next four weeks (weeks 9-12).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged 18-70 years;
✓. Written informed consent;
✓. Willing and able to comply with the protocol for the duration of the study;
✓. Chronic low back pain for at least 3 months from the screening;
✓. 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);
✓. Low back pain score of at least 5 on a 0-10 NRS at screening;
✓. Roland-Morris Disability Questionnaire score of at least 9 on the 24-point questionnaire at screening;
✓. 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\*.
Exclusion criteria
✕. Cauda equina syndrome;
What they're measuring
1
Pain reduction will be measured as difference of Numerical Rating Scale (NRS) value at Week 12 vs. baseline. The mean change in NRS score from baseline to Week 12 will be the primary efficacy endpoint.