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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01694134
Other study ID # 8833
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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