Treatment of Discogenic Back Pain

Not Applicable

Terminated

• Conditions: Discogenic Back Pain
• Interventions: Other: conventional treatment; Device: Discogel

• 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

Arm && Interventions

Group	Intervention	Description
conventional treatment	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
DISCOGEL	conventional treatment	Percutaneous intradiscal injection of Discogel
DISCOGEL	Discogel	Percutaneous intradiscal injection of Discogel

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