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

NCT01694134 | Completed Phase 3

• 1 other identifier: 8833
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Lumbago; Modic I Discopathy

Keywords

Discopathy; Modic I; Corticoids; Local Anaesthetic; Intradiscal injection

Outcome Measures

Primary Outcomes (1)

• Pain assessment: VAS

  The pain will be assessed by the visual analog scale (VAS).

  1 month

Secondary Outcomes (6)

• Pain assessment: VAS

  1 week, 2 weeks, 3 weeks, 3 months, 6 months

• Quality of life assessment: 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

  1 month, 3 months,6 months

• Specific low back pain parameters assessment

  1 month, 3 months,6 months

Study Arms (2)

Corticoids

ACTIVE COMPARATOR

A group of patients will receive an intradiscal injection of Hydrocortancyl.

Drug: Hydrocortancyl.

Local anaesthetic

SHAM COMPARATOR

A group of patients will receive an intradiscal injection of Lidocaine.

Drug: Lidocaine

Interventions

Hydrocortancyl. DRUG

Patients will receive an intradiscal injection of hydrocortancyl.

Corticoids

Lidocaine DRUG

Local anaesthetic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hospital University of Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Methylprednisolone; Lidocaine

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2012
• First Posted: September 26, 2012
• Study Start: July 12, 2012
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

FR (1)