NCT04757038

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

Status unknown NA Last updated 2 October 2023

What this trial tests

NA trial testing Intradiscal injection in Degenerative Disc Disease(DDD) in 42 participants. Status unknown.

Timeline

2 July 2021

Primary endpoint
9 September 2021

1 December 2024

Quick facts

Lead sponsor	Fidia Farmaceutici s.p.a.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	42
Start date	2 July 2021
Primary completion	9 September 2021
Estimated completion	1 December 2024
Sites	2 locations across Italy, Switzerland

Drugs / interventions tested

• Intradiscal injection

Conditions studied

• Degenerative Disc Disease(DDD) — all drugs for Degenerative Disc Disease(DDD) →

Sponsor

Fidia Farmaceutici s.p.a. — full company profile →

Who can join

Adults 18 to 70, any sex, with Degenerative Disc Disease(DDD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.