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

NCT04757038 | Unknown

• 1 other identifier: EQM2.20.01
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 2

Brief 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. 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).

Conditions

Degenerative Disc Disease(DDD)

Outcome Measures

Primary Outcomes (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.

  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

  week 12

Secondary Outcomes (8)

• To evaluate pain reduction, after treatment with HYALODISC + PEP compared to PEP alone;

  week 4 and 24

• To evaluate black disc hydration after HYALODISC + PEP, compared to PEP alone;

  week 12 and 24

• To evaluate patient's response to therapy according Roland-Morris Disability Questionnaire (RMDQ)

  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

  week 12 and 24

• To evaluate Patient's and investigator's global assessment of patient's health status (COGA/PTGA)

  week 4, 12 and 24

Study Arms (2)

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.

Device: Intradiscal injection

Physical exercise program (PEP)

NO INTERVENTION

Group 2: PEP alone

Interventions

Intradiscal injection DEVICE

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.

Also known as: Hyalodisc Injection

Hyalodisc injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*.
• 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..

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (2)

Unità operativa complessa di Radiologia PO.SS.Trinità

Cagliari, 09123, Italy

RECRUITING

Centro per la Terapia del Dolore NSI-EOC FMH Anestesiologia S.S.I.P.M.. Ospedale

Viganello, Lugano, CH-6962, Switzerland

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Stefano Marcia

  Presidio Ospedaliero SS Trinità Cagliari

  PRINCIPAL INVESTIGATOR

• Eva Koetsier

  Ospedale Regionale di Lugano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Giordan

CONTACT

+39 049 8232512; ngiordan@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 16, 2021
• Study Start: July 2, 2021
• Primary Completion: September 9, 2021
• Study Completion: December 1, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

CH (1); IT (1)