Treatment of Discogenic Back Pain

N/ATerminatedNCT02089139

University Hospital, Limoges40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Discogenic Back Pain

Interventions

DiscogelDEVICE

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

conventional treatmentOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHU Limoges

Limoges, France

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

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

Time frame: Six months after the procedure.

Secondary Outcomes

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 ;

Time frame: one month, three months, six months and 1 year after the procedure

Oswestry Disability Index (ODI)

Oswestry Disability Index (ODI) one month, three months, six months and 1 year after the procedure ;

Time frame: one month, three months, six months and 1 year after the procedure

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

Time frame: month, three months, six months and 1 year after the procedure

Data from ClinicalTrials.gov

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