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).
During the inclusion visit (V0) upon signature of the informed consent, eligible subject will be enrolled. At baseline visit (V1) eligible subjects will then randomly assigned to 1 of 2 treatment groups: HYALODISC + PEP (Group 1) or PEP alone (Group 2). At baseline visit (V1) HYALODISC (8 mg/ml) will be administered to group 1. The investigator will use one syringe for each involved disc, up to a maximum of three discs. The maximum volume that could be injected is 1.5 mL for each disc involved. The PEP session will start for both groups one week after V1. Randomized subjects will follow the instructions during the PEP session, for a total of 18 sessions that will be performed 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, all patients will be instructed how to continue these exercises at home, where the execution will be once a week in the first seven weeks (weeks 2-8) and twice a week in the next four weeks (weeks 9-12). Patients in group 2 that still present low back pain score \> 6, despite the PEP, at the physical examination at V3 (12 weeks after V1), could be treated with HYALODISC intradiscally. Those patients will be then evaluated at 12 weeks after the treatment (week 24). Follow-up visits are set at 4, 12 and 24 weeks (V2, V3 and V4)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
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.
Unità operativa complessa di Radiologia PO.SS.Trinità
Cagliari, Italy
RECRUITINGCentro per la Terapia del Dolore NSI-EOC FMH Anestesiologia S.S.I.P.M.. Ospedale
Viganello, Lugano, Switzerland
RECRUITINGPain 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.
Pain reduction will be measured as difference of Numerical Rating Scale (NRS) value at Week 12 vs. baseline in terms of mean change in NRS score from baseline to Week 12 will be the primary efficacy endpoint
Time frame: week 12
To evaluate pain reduction, after treatment with HYALODISC + PEP compared to PEP alone;
Pain reduction, measured as the mean change in NRS score from baseline to Week 4 and 24
Time frame: week 4 and 24
To evaluate black disc hydration after HYALODISC + PEP, compared to PEP alone;
Black disc hydration, measured as the percentage of patients with a reduction of at least one Pfirrmann grade.It will be evaluated by MRI at Week 12 and 24
Time frame: week 12 and 24
To evaluate patient's response to therapy according Roland-Morris Disability Questionnaire (RMDQ)
RMDQ, administered at screening and at week 4, 12 and 24 to evaluate clinical improvement after the treatment compared to the control group. The mean change in RMDQ score from baseline to Wee4, 12 and 24 will be considered for this endpoint
Time frame: week 4 ,12 and 24
To evaluate quality of life assessed by the mean change from baseline in the EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L) Index
The mean change in EQ-5D-5L score from baseline to Week 12 and 24
Time frame: week 12 and 24
To evaluate Patient's and investigator's global assessment of patient's health status (COGA/PTGA)
COGA /PTGA measured as the mean change in VAS (mm) from baseline to Week 4, Week 12, and Week 24
Time frame: week 4, 12 and 24
To evaluate Consumption of daily rescue medication (paracetamol)
Rescue medications consumption, reported by the patient using a daily diary in which the usage of rescue medication (paracetamol) will be recorded as number of rescue medications taken for LBP. The diary will be evaluated at week 4, 12 and 24 after treatment and compared to the control group. The number of patients who take at least one dose of rescue medication as well as the total amount of rescue medication taken over the study will be analyzed
Time frame: week 4,12,24
Consumption of daily rescue medication (paracetamol)
Rescue medications consumption, reported by the patient using a daily diary in which the usage of rescue medication (paracetamol) will be recorded as rescue medications taken for LBP. The diary will be evaluated at week 4, 12 and 24 after treatment and compared to the control group. The percentage of patients who take at least one dose of rescue medication as well as the total amount of rescue medication taken over the study will be analyzed
Time frame: week 4,12,24
To evaluate the safety profile and the local tolerability of HYALODISC.
Evaluated in terms of incidence of adverse events over the 24 weeks of the study.All adverse events (AEs) which occur during the study after the Subject has signed the ICF and (for Group 1) has received at least one dose of the product under investigation, whether referred by Subject, discovered by investigator questioning, or detected through physical examination, or by other means, must be collected and reported in the eCRF. As far as possible, each adverse event will be described by: * Duration (start and end dates); * Severity grade (mild, moderate, severe); * Causality (relationship) to the study product; * Action(s) taken; * Outcome.
Time frame: through study completion
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