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

Low Back Pain Clinical Trial

— MODISC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694134
• Other study ID #: 8833
• Status: Completed
• Phase: Phase 3
• Start date: July 12, 2012
• Est. completion date: March 20, 2017

Study information

• Verified date: January 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Low Back Pain
• Lumbago
• Modic I Discopathy

Intervention

Drug:
• Hydrocortancyl.
Patients will receive an intradiscal injection of hydrocortancyl.
• Lidocaine

Locations

Country	Name	City	State
France	Hospital University of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment: VAS	The pain will be assessed by the visual analog scale (VAS).	1 month
Secondary	Pain assessment: VAS	The pain will be assessed by the visual analog scale (VAS).	1 week, 2 weeks, 3 weeks, 3 months, 6 months
Secondary	Quality of life assessment: SF-36	Quality of life will be assessed by the self-questionnaire SF-36.	1 month, 3 months, 6 months
Secondary	Consumption of analgesics and NSAIDs assessment		1 month, 3 months,6 months
Secondary	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
Secondary	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
Secondary	Employment status	Employment or non-employment status will be noted	1 month, 3 months,6 months