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Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain

ConditionsPain, CervicalDiscogenic Pain
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-120
SponsorGelscom SAS

About this trial

The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient 18 years or older;

Pain refractory to conservative treatments for more than 2 months, non-surgical patients

Cervicobrachialgia due to disc herniation

Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI;

Disqualifiers

Prior surgical treatment of the disc(s) studied;

Sick leave of more than 12 months secondary to painful symptoms;

Patient with Modic 1 score or more

History of cognitive-behavioral disorders that could affect the completion of self-questionnaires;

Trial design

Design model

Single group

Treatments tested in this trial

  • Intradiscal Gelified Ethanol (Discogel)

    Device

    Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Intradiscal Gelified Ethanol ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months)

In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").

Time frame
3 months

Secondary outcomes

1

Change in pain cervical intensity using the verbal local rating scale [

Scores range from 0-10. In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").

Time frame
12 months
2

Change of consumption of painkillers

Number, frequency and dosage of pain relief treatments will be combine todescribe the difference in painkiller consumption before and after the operation

Time frame
12 months
3

Incidence of complication and adverse event rates

Incidence of adverse event during 12 months after the treatment

Time frame
12 months
4

Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].

The Neck Disability Index (NDI) is used to measure pain-related disability associated with activities of daily living in people with neck pain (index between 0 and 50). The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, above 34 = complete. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gelscom SAS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: