Degenerative Disc Disease(DDD)NCT04757038
An Open Label, Randomized-controlled Trial to Assess Efficacy Safety of HYALODISC With Physical Exercise Program
A study testing Intradiscal injection in people with Degenerative Disc Disease(DDD), run by Fidia Farmaceutici s.p.a. at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease(DDD)
- What is being tested?
- Intradiscal injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Jul 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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*.
- 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..
Who cannot join
- Cauda equina syndrome;
- Active malignancy or tumours as source of symptoms;
- Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection;
- Previous lumbar spine surgery;
- Evidence of prior lumbar vertebral body fracture;
- Patients with radiculopathy caused by nerve root compression;
Show all 21Show fewer
- Verbiest Syndrome of Lumbar Spine;
- Spondylolisthesis (> Grade 1) with or without spondylolysis at the symptomatic level(s);
- Radiological sacroiliac joint involvement;
- Patients with positive response to medial branch block;
- Patients that did physical exercise therapy in the last three months before screening;
- 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;
- Sacrum-iliac synchondrosis agenesis seen on MRI;
- Patients with symptomatic hernia, sciatica or spinal cord injury:
- Significant systemic disease, including unstable angina, autoimmune disease, rheumatoid arthritis, and muscular dystrophy;
- Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications; or undergoing radiation therapy;
- Patients with known allergies, hypersensitivity or intolerance to paracetamol and/or active or inactive excipients of formulation;
- Ongoing or previous participation in another drug or device clinical study within the previous 2 months from the screening;
- 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;
- Patients with suspected or known history of hypersensitivity to hyaluronic acid or to hyaluronate preparations or gram-positive bacterial proteins;
- Patients unable to provide a valid informed consent or those acting in an emergency situation..
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Unità operativa complessa di Radiologia PO.SS.Trinità
Cagliari, 09123
Stefano Marcia, MD
Switzerland1 site, 1 recruiting
- Recruiting
Centro per la Terapia del Dolore NSI-EOC FMH Anestesiologia S.S.I.P.M.. Ospedale
Viganello, Lugano, CH-6962
Eva Koetsier, MD
About this study
Official title: 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
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:
Read more
- 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).
Read the detailed description
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)
- Conditions
- Degenerative Disc Disease(DDD)
- Being tested
- Intradiscal injection
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradiscal injectionDevice
Also called Hyalodisc Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyalodisc injection | Experimental | • 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.
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. Receives: Device: Intradiscal injection |
| Physical exercise program (PEP) | No intervention | Group 2: PEP alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: week 12
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start2 Jul 2021
- Primary completion9 Sep 2021
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease(DDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefano Marcia, Principal investigator, Presidio Ospedaliero SS Trinità CagliariEva Koetsier, Principal investigator, Ospedale Regionale di Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757038
- Sponsor's protocol ID
- EQM2.20.01
- Status last verified
- Sep 2023
- First submitted
- 10 Feb 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04757038
- Acronym / sponsor ID
- EQM2.20.01
- Conditions
- Degenerative Disc Disease(DDD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyalodisc injection | Experimental | Device: Intradiscal injection• 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. 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. |
| Physical exercise program (PEP) | No intervention | –Group 2: PEP alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (21 listed)
- Cauda equina syndrome;
- Active malignancy or tumours as source of symptoms;
- Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection;
- Previous lumbar spine surgery;
- Evidence of prior lumbar vertebral body fracture;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradiscal injectionAlso: Hyalodisc InjectionThe 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. | Device | Hyalodisc injection |
Primary outcome
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.
Time frame: week 12
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
8 secondary outcomes
To evaluate pain reduction, after treatment with HYALODISC + PEP compared to PEP alone;
Time frame: week 4 and 24
To evaluate black disc hydration after HYALODISC + PEP, compared to PEP alone;
Time frame: week 12 and 24
To evaluate patient's response to therapy according Roland-Morris Disability Questionnaire (RMDQ)
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
Time frame: week 12 and 24
To evaluate Patient's and investigator's global assessment of patient's health status (COGA/PTGA)
Time frame: week 4, 12 and 24
To evaluate Consumption of daily rescue medication (paracetamol)
Time frame: week 4,12,24
Consumption of daily rescue medication (paracetamol)
Time frame: week 4,12,24
To evaluate the safety profile and the local tolerability of HYALODISC.
Time frame: through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
Related trials for Degenerative Disc Disease(DDD)
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
RecruitingPhase 3
A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
Degenerative Disc Disease
Recruiting
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
Degenerative Disc Disease (DDD)
Recruiting
Biologic Injection For Adults With Lumbar Disc Herniation
Degenerative Disc Disease, DDD
Recruiting
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Degenerative Disc Disease, Chronic Low-back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Marcia principal investigator
Presidio Ospedaliero SS Trinità Cagliari
Eva Koetsier principal investigator
Ospedale Regionale di Lugano
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradiscal injection in people with Degenerative Disc Disease(DDD), run by Fidia Farmaceutici s.p.a. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Giordan (+39 049 8232512, ngiordan@fidiapharma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.