Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (MODISC)

The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Lumbago; Modic I Discopathy
• Intervention / Treatment: Drug: Lidocaine; Drug: Hydrocortancyl.

Detailed Description

This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • Hospital University of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 80 years
• Signed Informed consent
• Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)

Exclusion Criteria:

• Past history of lumbar surgery
• Patient under anticoagulant or antisludge treatment, or with coagulation troubles
• Patient with unbalanced diabetes mellitus (blood glucose > 1.30 g/l)
• Patient with unstabilized high blood pressure (> 160/95 mmHg)
• Patient with evolving infection
• Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
• Porphyria, hypersensitivity to local anaesthetic
• Patient with sphincter troubles showing a cauda equine syndrome
• Untreated psychotic state
• Pregnant women or of childbearing age without effective contraception means
• Impossible 6 months follow-up
• Participation to another trial
• Vulnerable persons protected by the law
• Persons under guardianship
• Persons unable to express their consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Corticoids; A group of patients will receive an intradiscal injection of Hydrocortancyl.	Drug: Hydrocortancyl.; Patients will receive an intradiscal injection of hydrocortancyl.
Sham Comparator: Local anaesthetic; A group of patients will receive an intradiscal injection of Lidocaine.	Drug: Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment: VAS	The pain will be assessed by the visual analog scale (VAS).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment: VAS	The pain will be assessed by the visual analog scale (VAS).	1 week, 2 weeks, 3 weeks, 3 months, 6 months
Quality of life assessment: SF-36	Quality of life will be assessed by the self-questionnaire SF-36.	1 month, 3 months, 6 months
Consumption of analgesics and NSAIDs assessment		1 month, 3 months,6 months
Specific low back pain parameters assessment	Low back pain parameters will be assessed by the Dallas scale.The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life .	1 month, 3 months,6 months
Specific low back pain parameters assessment	Low back pain parameters will be assessed by the Oswestry scale. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.	1 month, 3 months,6 months
Employment status	Employment or non-employment status will be noted	1 month, 3 months,6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2012
• Primary Completion (Actual): March 20, 2017
• Study Completion (Actual): March 20, 2017

Study Registration Dates

• First Submitted: September 22, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Corticoids; Discopathy; Modic I; Local Anaesthetic; Intradiscal injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Lidocaine
• Other Study ID Numbers: 8833