Low Back PainNCT02343484

Intradiscal Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for Discogenic Low Back Pain

A study testing Gelified ethanol combined to pulsed radiofrequency and Gelified ethanol in people with Low Back Pain, run by Attikon Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Many different minimally invasive techniques have been used for the treatment of chronic discogenic low back pain refractory to conservative treatments, with various results. The aim of this study is to assess the efficacy of the combination of intradiscal pulsed radiofrequency and gelified ethanol versus gelified… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: Gelified ethanol combined to pulsed radiofrequency and Gelified ethanol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteGreece
Study dates: Mar 2013to Sep 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Discogenic low back pain > 6 months,
pain refractory to conservative treatment,
no other aetiology for pain,
pain reported during provocative discography according to standard criteria,
MRI imaging indicating disk degenarative disease

Who cannot join

Red flags for low back pain,
lumbosacral radiculopathy,
extruded or sequestered lumbar disc,
severe spinal stenosis,
facet joint syndrome,
sacroiliac joint pain,

Show all 11Show fewer

neurological disorders,
psychiatric disorders,
rheumatoid arhtritis, ancylosing spondylitis, other autoimmune arthritis,
coagulation disorders,
pregnancy

Trial locations and contacts

1 site in 1 country.

Greece1 site

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462

Other trials in Greece

About this study

Official title: Intradiscal Combination of Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for the Treatment of Chronic Discogenic Low Back Pain. A Randomized Controlled Trial.

Conditions: Low Back Pain
Being tested: Gelified ethanol combined to pulsed radiofrequency, Gelified ethanol
Keywords: pulsed radiofrequency, gelified ethanol
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gelified ethanol combined to pulsed radiofrequencyDrug
Also called Discogel, PRF
Gelified ethanol (Discogel) is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain. The intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.
Gelified ethanolDrug
Also called Discogel
Gelified ethanol is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally.

Study groups in NCT02343484
Study group	Role	What they receive
Gelified ethanol	Active comparator	Gelified ethanol (Discogel) is a sterile, implantable medical solution containing ethyl alcohol, cellulose derivative product and an opaque agent (tungsten). The implant is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. The implant causes migration of fluid (by hydrophilic and osmotic phenomena) from the periphery towards the center, causing disk reinforcement. Filling of the annulus fibrosus tears interrupts the outflow of inflammatory factors towards dorsal root ganglions, dura and posterior longitudinal ligament. Receives: Drug: Gelified ethanol
Gelified ethanol combined to pulsed radiofrequency	Active comparator	Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain.Intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle. Receives: Drug: Gelified ethanol combined to pulsed radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Numeric Rating Scale (NRS)
Mean pain intensity assessed by VAS 1, 3, 6 and 12 months after the procedure.
Measured: One, three, six and twelve months after the procedure.
Change in Rolland Morris questionnaire
Functional status of patient assessed by Rolland Morris questionnaire 1, 3, 6 and 12 months after the procedure.
Measured: One, three, six and twelve months after the procedure.

Secondary outcomes (2)

Change in Quality of life (EQ 5D)
Quality of life assessed via EQ 5D questionnaire 1, 3, 6 and 12 months after the procedure
Measured: One, three, six and twelve months after the procedure.
Change in Satisfaction from therapy ( assessed via NRS 0-10)
Satisfaction from therapy assessed via NRS 0-10 1, 3, 6 and 12 months after the procedure
Measured: One, three, six and twelve months after the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Sep 2017

First posted22 Jan 2015 (estimated)
Study startMar 2013
Primary completionSep 2017
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02343484
Sponsor's protocol ID: 2/8-2-13
Status last verified: Sep 2017
First submitted: 13 Jan 2015
Last updated: 3 Oct 2017
Results posted: No
Data monitoring committee: No

Publications

Bellini M, Romano DG, Leonini S, Grazzini I, Tabano C, Ferrara M, Piu P, Monti L, Cerase A. Percutaneous injection of radiopaque gelified ethanol for the treatment of lumbar and cervical intervertebral disk herniations: experience and clinical outcome in 80 patients. AJNR Am J Neuroradiol. 2015 Mar;36(3):600-5. doi: 10.3174/ajnr.A4166. Epub 2014 Nov 13.
PubMed 25395657
Guarnieri G, De Dominicis G, Muto M. Intradiscal and intramuscular injection of discogel((R)) - radiopaque gelified ethanol: pathological evaluation. Neuroradiol J. 2010 Apr;23(2):249-52. doi: 10.1177/197140091002300216. Epub 2010 Apr 20.
PubMed 24148546
Theron J, Guimaraens L, Casasco A, Sola T, Cuellar H, Courtheoux P. Percutaneous treatment of lumbar intervertebral disk hernias with radiopaque gelified ethanol: a preliminary study. J Spinal Disord Tech. 2007 Oct;20(7):526-32. doi: 10.1097/BSD.0b013e318033e860.
PubMed 17912130
Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283.
PubMed 23615883
Jung YJ, Lee DG, Cho YW, Ahn SH. Effect of intradiscal monopolar pulsed radiofrequency on chronic discogenic back pain diagnosed by pressure-controlled provocative discography: a one year prospective study. Ann Rehabil Med. 2012 Oct;36(5):648-56. doi: 10.5535/arm.2012.36.5.648. Epub 2012 Oct 31.
PubMed 23185729
Rohof O. Intradiscal pulsed radiofrequency application following provocative discography for the management of degenerative disc disease and concordant pain: a pilot study. Pain Pract. 2012 Jun;12(5):342-9. doi: 10.1111/j.1533-2500.2011.00512.x. Epub 2011 Oct 19.
PubMed 22008239
Fukui S, Rohof O. Results of pulsed radiofrequency technique with two laterally placed electrodes in the annulus in patients with chronic lumbar discogenic pain. J Anesth. 2012 Aug;26(4):606-9. doi: 10.1007/s00540-012-1385-7. Epub 2012 Apr 5.
PubMed 22476553
Fukui S, Nitta K, Iwashita N, Tomie H, Nosaka S, Rohof O. Results of intradiscal pulsed radiofrequency for lumbar discogenic pain: comparison with intradiscal electrothermal therapy. Korean J Pain. 2012 Jul;25(3):155-60. doi: 10.3344/kjp.2012.25.3.155. Epub 2012 Jun 28.
PubMed 22787545

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intradiscal Combination of Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for the Treatment of Chronic Discogenic Low Back Pain. A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT02343484
Acronym / sponsor ID: 2/8-2-13
Conditions: Low Back Pain
Keywords: pulsed radiofrequency, gelified ethanol
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Attikon HospitalUniversity, hospital or other
Study start: Mar 2013
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 22 Jan 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Gelified ethanol	Active comparator	Drug: Gelified ethanolGelified ethanol (Discogel) is a sterile, implantable medical solution containing ethyl alcohol, cellulose derivative product and an opaque agent (tungsten). The implant is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. The implant causes migration of fluid (by hydrophilic and osmotic phenomena) from the periphery towards the center, causing disk reinforcement. Filling of the annulus fibrosus tears interrupts the outflow of inflammatory factors towards dorsal root ganglions, dura and posterior longitudinal ligament.
Gelified ethanol combined to pulsed radiofrequency	Active comparator	Drug: Gelified ethanol combined to pulsed radiofrequencyPulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain.Intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Discogenic low back pain > 6 months,
pain refractory to conservative treatment,
no other aetiology for pain,
pain reported during provocative discography according to standard criteria,
MRI imaging indicating disk degenarative disease

Key exclusion criteria (11 listed)

Red flags for low back pain,
lumbosacral radiculopathy,
extruded or sequestered lumbar disc,
severe spinal stenosis,
facet joint syndrome,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gelified ethanol combined to pulsed radiofrequencyAlso: Discogel, PRFGelified ethanol (Discogel) is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain. The intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.	Drug	Gelified ethanol combined to pulsed radiofrequency
Gelified ethanolAlso: DiscogelGelified ethanol is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally.	Drug	Gelified ethanol

Primary outcome

Change in Numeric Rating Scale (NRS)
Time frame: One, three, six and twelve months after the procedure.
Mean pain intensity assessed by VAS 1, 3, 6 and 12 months after the procedure.
Change in Rolland Morris questionnaire
Time frame: One, three, six and twelve months after the procedure.
Functional status of patient assessed by Rolland Morris questionnaire 1, 3, 6 and 12 months after the procedure.

2 secondary outcomes

Change in Quality of life (EQ 5D)
Time frame: One, three, six and twelve months after the procedure.
Change in Satisfaction from therapy ( assessed via NRS 0-10)
Time frame: One, three, six and twelve months after the procedure.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
Background: PubMed 25395657Bellini M, Romano DG, Leonini S, Grazzini I, Tabano C, Ferrara M, Piu P, Monti L, Cerase A. Percutaneous injection of radiopaque gelified ethanol for the treatment of lumbar and cervical intervertebral disk herniations: experience and clinical outcome in 80 patients. AJNR Am J Neuroradiol. 2015 Mar;36(3):600-5. doi: 10.3174/ajnr.A4166. Epub 2014 Nov 13.
Background: PubMed 24148546Guarnieri G, De Dominicis G, Muto M. Intradiscal and intramuscular injection of discogel((R)) - radiopaque gelified ethanol: pathological evaluation. Neuroradiol J. 2010 Apr;23(2):249-52. doi: 10.1177/197140091002300216. Epub 2010 Apr 20.
Background: PubMed 17912130Theron J, Guimaraens L, Casasco A, Sola T, Cuellar H, Courtheoux P. Percutaneous treatment of lumbar intervertebral disk hernias with radiopaque gelified ethanol: a preliminary study. J Spinal Disord Tech. 2007 Oct;20(7):526-32. doi: 10.1097/BSD.0b013e318033e860.
Background: PubMed 23615883Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283.
Background: PubMed 23185729Jung YJ, Lee DG, Cho YW, Ahn SH. Effect of intradiscal monopolar pulsed radiofrequency on chronic discogenic back pain diagnosed by pressure-controlled provocative discography: a one year prospective study. Ann Rehabil Med. 2012 Oct;36(5):648-56. doi: 10.5535/arm.2012.36.5.648. Epub 2012 Oct 31.
Background: PubMed 22008239Rohof O. Intradiscal pulsed radiofrequency application following provocative discography for the management of degenerative disc disease and concordant pain: a pilot study. Pain Pract. 2012 Jun;12(5):342-9. doi: 10.1111/j.1533-2500.2011.00512.x. Epub 2011 Oct 19.
Background: PubMed 22476553Fukui S, Rohof O. Results of pulsed radiofrequency technique with two laterally placed electrodes in the annulus in patients with chronic lumbar discogenic pain. J Anesth. 2012 Aug;26(4):606-9. doi: 10.1007/s00540-012-1385-7. Epub 2012 Apr 5.
Background: PubMed 22787545Fukui S, Nitta K, Iwashita N, Tomie H, Nosaka S, Rohof O. Results of intradiscal pulsed radiofrequency for lumbar discogenic pain: comparison with intradiscal electrothermal therapy. Korean J Pain. 2012 Jul;25(3):155-60. doi: 10.3344/kjp.2012.25.3.155. Epub 2012 Jun 28.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gelified ethanol combined to pulsed radiofrequency and Gelified ethanol in people with Low Back Pain, run by Attikon Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numeric Rating Scale (NRS) (time frame: One, three, six and twelve months after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02343484, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.