Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease (NCT04727385) | Clinical Trial Compass
UnknownNot Applicable
Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
France20 participantsStarted 2020-09-15
Plain-language summary
The purpose of this study is to assess the safety and the efficacy of an hydrogel (double cross-link microgel - DXM) injection into the intervertebral disc (IVD) space in patients with painful lumbar degenerative disc disease (DDD) over 24 to 48 weeks.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patient aged between 18 and 55 (inclusive)
. Discogenic low back pain, confirmed by a history of Low Back Pain, with a minimum of 3 months of continuous pain or 6 months of acute episodes of pain despite the conservative treatment including painkillers and physiotherapy
. Oswestry Disability Index (ODI) ≥ 30% and ≤ 60%,
. Painful disc(s) between L1 and S1 represented
. For cohort 1L: at a single disc level
. For cohort 2L: at 2 disc levels
. For cohort 1-2L: at 1 or 2 disc levels
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients with at least one adverse event (AE) or serious adverse event (SAE)
Timeframe: Between screening visit and 24 weeks (measured at each visits)
2
The number of adverse events (AEs) or serious adverse event (SAEs)
Timeframe: Between screening visit and 24 weeks (measured at each visits)
3
The number of patients with neurological changes during the follow-up period according to the evaluation of nerve root pain, sensory deficit and motor deficit
Timeframe: Between screening visit and 24 weeks (measured at each visits)
4
The change of the water content of the nucleus measured in milliseconds on the MRI during the follow-up period
Timeframe: Between screening visit and 24 weeks (measured at each visits)
5
The modifications observed after the injection in the adjacent tissues of the injected nucleus
Timeframe: Between screening visit and 24 weeks (measured at each visits)
6
The change of the intervertebral height in millimetres of the injected disc
Timeframe: Between screening visit and 24 weeks (measured at each visits)
. Patients with a Zung depression score ≤ 49, Note: Patients with a Zung depression score between ≥ 50 and ≤ 64 may be included if deemed suitable for trial inclusion by the investigator
Exclusion criteria
. Averted nerve root pain and potential root compression Note: Referred leg pain authorised
. Presence of posterior bone spurs (osteophytes)
. Partial or total Modic signal grade 1 at the considered disc level
. Patients with active systemic infection or infection localized to the site of the proposed implantation.
. Any conditions not described in the indications for use.
. Any mental conditions or neuromuscular disease that may generate an unacceptable risk of failure or postoperative complication.
. Patients with existing disc herniation at the considered level and on adjacent discs
. Endplate disease, defect or weakness, e.g. Schmorl nodule
7
The change of the DXM gel position in relation to posterior and anterior limit of the annulus fibrosus and vertebral disc end-plates
Timeframe: Between screening visit and 24 weeks (measured at each visits)