Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticoids | Active Comparator | A group of patients will receive an intradiscal injection of Hydrocortancyl. |
|
| Local anaesthetic | Sham Comparator | A group of patients will receive an intradiscal injection of Lidocaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortancyl. | Drug | Patients will receive an intradiscal injection of hydrocortancyl. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment: VAS | The pain will be assessed by the visual analog scale (VAS). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment: VAS | The pain will be assessed by the visual analog scale (VAS). | 1 week, 2 weeks, 3 weeks, 3 months, 6 months |
| Quality of life assessment: SF-36 | Quality of life will be assessed by the self-questionnaire SF-36. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital University of Montpellier | Montpellier | 34000 | France |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lidocaine |
| Drug |
|
| 1 month, 3 months, 6 months |
| Consumption of analgesics and NSAIDs assessment | 1 month, 3 months,6 months |
| 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 |
| 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 |
| Employment status | Employment or non-employment status will be noted | 1 month, 3 months,6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |