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

Primary Purpose

Low Back Pain, Lumbago, Modic I Discopathy

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hydrocortancyl.
Lidocaine
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Discopathy, Modic I, Corticoids, Local Anaesthetic, Intradiscal injection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital University of Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Corticoids

Local anaesthetic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain assessment: VAS
The pain will be assessed by the visual analog scale (VAS).
Quality of life assessment: SF-36
Quality of life will be assessed by the self-questionnaire SF-36.
Consumption of analgesics and NSAIDs assessment
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 .
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.
Employment status
Employment or non-employment status will be noted

Full Information

First Posted
September 22, 2012
Last Updated
January 30, 2020
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01694134
Brief Title
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
Acronym
MODISC
Official Title
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2012 (Actual)
Primary Completion Date
March 20, 2017 (Actual)
Study Completion Date
March 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Lumbago, Modic I Discopathy
Keywords
Discopathy, Modic I, Corticoids, Local Anaesthetic, Intradiscal injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticoids
Arm Type
Active Comparator
Arm Description
A group of patients will receive an intradiscal injection of Hydrocortancyl.
Arm Title
Local anaesthetic
Arm Type
Sham Comparator
Arm Description
A group of patients will receive an intradiscal injection of Lidocaine.
Intervention Type
Drug
Intervention Name(s)
Hydrocortancyl.
Intervention Description
Patients will receive an intradiscal injection of hydrocortancyl.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Primary Outcome Measure Information:
Title
Pain assessment: VAS
Description
The pain will be assessed by the visual analog scale (VAS).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pain assessment: VAS
Description
The pain will be assessed by the visual analog scale (VAS).
Time Frame
1 week, 2 weeks, 3 weeks, 3 months, 6 months
Title
Quality of life assessment: SF-36
Description
Quality of life will be assessed by the self-questionnaire SF-36.
Time Frame
1 month, 3 months, 6 months
Title
Consumption of analgesics and NSAIDs assessment
Time Frame
1 month, 3 months,6 months
Title
Specific low back pain parameters assessment
Description
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 .
Time Frame
1 month, 3 months,6 months
Title
Specific low back pain parameters assessment
Description
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.
Time Frame
1 month, 3 months,6 months
Title
Employment status
Description
Employment or non-employment status will be noted
Time Frame
1 month, 3 months,6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital University of Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

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

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