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Can a gel injection into spinal discs relieve chronic neck pain?

NCT ID NCT07832929

Symptom relief Sponsor: Aurel Mengri Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers at an Italian hospital are observing adults with cervical disc herniation who receive intradiscal radiopaque gelified ethanol (Absolute Gel) as part of their routine care. The study tracks about 45 participants for up to 48 months, measuring changes in neck pain intensity. It is observational, meaning the treatment is chosen by the treating physician and not assigned by the study. The main goal is to describe how pain scores change over time, not to prove the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiopaque gelified ethanol, a gel-like alcohol injected into damaged spinal discs
What this could lead to
If the approach helps, it could offer a minimally invasive option for chronic neck pain from cervical disc herniation, potentially reducing the need for surgery in some patients.
What could go wrong
This is a small observational study with no comparison group, so it cannot prove the treatment works. Results may reflect natural recovery or placebo effects, and the procedure carries risks such as infection, bleeding, or nerve injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults aged 18 to 75 years with MRI-confirmed cervical disc herniation and persistent discogenic neck pain not adequately controlled by conservative therapy, who have already been treated with, or are candidates for, intradiscal radiopaque gelified ethanol (Absolute Gel) as part of routine clinical practice at Ospedale di Vimercate, ASST Brianza. Participants are identified from the patient population of the investigator at the specialised pain management and interventional spine service. Both retrospectively and prospectively enrolled participants are included.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, aged 18 to 75 years, already treated with or candidate for Absolute Gel for cervical disc herniation as part of standard clinical practice * Signed informed consent to participate in the study (prospective participants; retrospective participants according to the conditions approved by the Ethics Committee) * Discogenic neck pain confirmed by a history of cervical neck pain, with at least 3 months of continuous pain or 6 months of acute recurrent episodes despite conservative treatment including analgesics and physiotherapy * Baseline neck pain intensity VAS greater than 4 out of 10 * Cervical disc herniation documented by MRI * Contained herniation without complete annulus tear, with integrity of the posterior longitudinal ligament and no free fragments, assessed by MRI or CT Exclusion Criteria: * Active local or systemic infection (systemic or cervical) * Known contraindications to ethanol or to device components * Coagulopathy or anticoagulant therapy that cannot be discontinued according to clinical practice * Serious medical or systemic disease making the treatment inappropriate according to clinical judgement * Psychiatric or cognitive disorders preventing a reliable assessment * Pregnancy or breastfeeding * Sequestered or migrated disc herniation * Severe disc degeneration not compatible with the clinical use of Absolute Gel (for example disc collapse greater than 60%, Pfirrmann grade IV-V according to clinical judgement) * Clinically significant severe foraminal or central stenosis * Instability (for example spondylolisthesis greater than Meyerding grade I) * Significant vertebral abnormalities (for example fractures, active angiomas, severe scoliosis greater than 20 degrees Cobb, significant kyphosis) * Severe posterior osteophytes compromising access or treatment safety * Clinically significant facet joint disorders (for example severe osteoarthritis) * Inadequate skin coverage or local conditions impeding the procedure * Previous cervical surgery at the treated disc level * Severe neurological deficit (for example motor strength less than 3/5) not exclusively attributable to the contained herniation * Any other condition that, in the judgement of the treating physician, makes the treatment inappropriate in routine clinical practice

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome Intervertebral Disc Displacement Neck Pain radiculopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical disc herniation Chronic pain Intervertebral disc displacement Neck pain Radiculopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ospedale di Vimercate - ASST Brianza

    RECRUITING

    Vimercate, Monza E Brianza, 20871, Italy

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