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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT01694134

Collaborator

(none)

Enrollment

Location

Arms

56.2

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Lumbago Modic I Discopathy	Drug: Hydrocortancyl. Drug: Lidocaine	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 12, 2012

Actual Primary Completion Date :

Mar 20, 2017

Actual Study Completion Date :

Mar 20, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain assessment: VAS [1 month]
The pain will be assessed by the visual analog scale (VAS).

Secondary Outcome Measures

Pain assessment: VAS [1 week, 2 weeks, 3 weeks, 3 months, 6 months]
The pain will be assessed by the visual analog scale (VAS).
Quality of life assessment: SF-36 [1 month, 3 months, 6 months]
Quality of life will be assessed by the self-questionnaire SF-36.
Consumption of analgesics and NSAIDs assessment [1 month, 3 months,6 months]
Specific low back pain parameters assessment [1 month, 3 months,6 months]
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 .
Specific low back pain parameters assessment [1 month, 3 months,6 months]
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.
Employment status [1 month, 3 months,6 months]
Employment or non-employment status will be noted

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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