Treatment of Discogenic Back Pain

Discogenic Back Pain Clinical Trial

— EGID  

Official title:

Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02089139
• Other study ID #: I13009
• Status: Terminated
• Phase: N/A
• First received: March 13, 2014
• Last updated: September 9, 2015
• Start date: May 2014
• Est. completion date: September 2018

Study information

• Verified date: September 2015
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.

In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• MR imaging : MODIC 1or MODIC 2 changes limited to one single lumbar disc;

• X rays: normal disc height, no instability;

• Back pain for at least 3 months, without argument for another etiology;

• Mean pain on 5 days VAS = 5

Exclusion Criteria:

• age <18 years or > 50 ; concomitant radicular pain ;

• psychiatric pathology that may modify the perception or the evolution of pain;

• MR imaging: multi-level discopathy, MODIC 3 changes;

• X ray: loss of disc height > 50%, segmental instability;

• previous history of lumbar surgery with or without instrumentation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Discogenic Back Pain

Intervention

Device:
• Discogel
DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)

Other:
• conventional treatment
Conventional treatment based on current guidelines regarding the management of discogenic low back pain, including but not limited to: medications (analgesics, NSAIDs, muscle relaxants), physical therapy, manual techniques, transcutaneous electrical nerve stimulation (TENS), blocks

Locations

Country	Name	City	State
France	CHU Limoges	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	GELSCOM

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.	Six months after the procedure.	No
Secondary	Visual Analog Scale (VAS),	Mean pain intensity score on Visual Analog Scale (VAS), one month, three months, six months and 1 year after the procedure ;	one month, three months, six months and 1 year after the procedure	No
Secondary	Oswestry Disability Index (ODI)	Oswestry Disability Index (ODI) one month, three months, six months and 1 year after the procedure ;	one month, three months, six months and 1 year after the procedure	No
Secondary	Euroqol score	Assessment of the quality of life with Euroqol score (EQ-5D) one month, three months, six months and 1 year after the procedure	month, three months, six months and 1 year after the procedure	No