search
Back to results

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

Primary Purpose

Pain, Cervical, Discogenic Pain

Status
Not yet recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Intradiscal Gelified Ethanol
Sponsored by
Gelscom SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Cervical

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Patient agreeing to participate in the study and having given written consent; Patient enrolled in a health insurance plan. Exclusion Criteria: 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; Local or systemic infection, or suspicion of infection; Severe coagulation disorders; Other inflammatory rheumatic disease; Severe underlying pathology with life expectancy <1 year; Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0); Known allergy to contrast material and/or local anesthetic substances; Patients who cannot read or write Italian; Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);

Sites / Locations

  • Santissima Trinità Hospital Ascagliari
  • Azienda Ospedaliera Universitaria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intradiscal Gelified Ethanol Arm

Arm Description

Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria.

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

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").
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
Incidence of complication and adverse event rates
Incidence of adverse event during 12 months after the treatment
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.
Subjective evaluation MacNab
The MacNab's scale is layered into 4 levels (excellent, good, fair and poor) according to the patient's well-being after surgery or procedure.The scores were divided into the following four grades: 75-100% (excellent), 50-74% (good), 25-49% (fair) and 0-24% (poor). "Excellent" is defined as "No pain; no restriction of activity". "Good" is defined as "Occasional pain of sufficient severity to interfere with the patient's ability to do his normal work or his capacity to enjoy himself in leisure hours".

Full Information

First Posted
July 7, 2023
Last Updated
July 28, 2023
Sponsor
Gelscom SAS
search

1. Study Identification

Unique Protocol Identification Number
NCT05969392
Brief Title
Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
Acronym
DISCERV
Official Title
Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gelscom SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Detailed Description
After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cervical, Discogenic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intradiscal Gelified Ethanol Arm
Arm Type
Experimental
Arm Description
Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria.
Intervention Type
Device
Intervention Name(s)
Intradiscal Gelified Ethanol
Intervention Description
Intradiscal percutaneous injection of an intradiscal Gelified Ethanol
Primary Outcome Measure Information:
Title
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)
Description
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 Outcome Measure Information:
Title
Change in pain cervical intensity using the verbal local rating scale [
Description
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
Title
Change of consumption of painkillers
Description
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
Title
Incidence of complication and adverse event rates
Description
Incidence of adverse event during 12 months after the treatment
Time Frame
12 months
Title
Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].
Description
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
Title
Subjective evaluation MacNab
Description
The MacNab's scale is layered into 4 levels (excellent, good, fair and poor) according to the patient's well-being after surgery or procedure.The scores were divided into the following four grades: 75-100% (excellent), 50-74% (good), 25-49% (fair) and 0-24% (poor). "Excellent" is defined as "No pain; no restriction of activity". "Good" is defined as "Occasional pain of sufficient severity to interfere with the patient's ability to do his normal work or his capacity to enjoy himself in leisure hours".
Time Frame
12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Patient agreeing to participate in the study and having given written consent; Patient enrolled in a health insurance plan. Exclusion Criteria: 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; Local or systemic infection, or suspicion of infection; Severe coagulation disorders; Other inflammatory rheumatic disease; Severe underlying pathology with life expectancy <1 year; Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0); Known allergy to contrast material and/or local anesthetic substances; Patients who cannot read or write Italian; Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);
Facility Information:
Facility Name
Santissima Trinità Hospital Ascagliari
City
Cagliari
ZIP/Postal Code
9121
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Marcia, Pr
Email
stemarcia@gmail.com
Facility Name
Azienda Ospedaliera Universitaria
City
Siena
ZIP/Postal Code
53000
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Bellini, Dr
Email
matteo.bellini@icloud.com
First Name & Middle Initial & Last Name & Degree
Chiara Zini
Email
zini.chiara@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Confidential data (Pre-market Study trial)

Learn more about this trial

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

We'll reach out to this number within 24 hrs