Treatment of Discogenic Back Pain

Not Applicable

Terminated

• Conditions: Discogenic Back Pain

• Registration Number: NCT02089139
• Lead Sponsor: University Hospital, Limoges

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Study Start: 2014-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-11
• Primary Completion: 2018-05
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Six months after the procedure.	Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	one month, three months, six months and 1 year after the procedure	Oswestry Disability Index (ODI) one month, three months, six months and 1 year after the procedure ;
Euroqol score	month, three months, six months and 1 year after the procedure	Assessment of the quality of life with Euroqol score (EQ-5D) one month, three months, six months and 1 year after the procedure
Visual Analog Scale (VAS),	one month, three months, six months and 1 year after the procedure	Mean pain intensity score on Visual Analog Scale (VAS), one month, three months, six months and 1 year after the procedure ;

Trial Locations

Locations (1)

CHU Limoges; 🇫🇷 Limoges, France