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The study consists in evaluating the analgesic efficacy of Gabapentin versus Placebo in the short term (72h) acute lumbosacral radiculalgia due to disc herniation.
In addition to the usual analgesic treatment, the patient will receive gabapentin or placebo.
During the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.
The objective of the study is to evaluate the analgesic efficacy of GABAPENTIN versus Placebo in 72h for hospitalised patients suffering from acute lumbosacral radiculalgia due to disc herniation.
After signing the consent form, patient's clinical data will be collected and the patient will be allocated to one treatment arm by the randomisation process (ratio 1:1 and stratified on the strong opioid intake).
Two treatment arms are possible :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental | GABAPENTIN per os*:
|
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| Placebo | Placebo Comparator | PLACEBO:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin 300mg | Drug | The patient will receive in addition to the usual analgesic treatment, the treatment under study: Gabapentin. During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be performed. The patient will have to take the treatment as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogical Scale (VAS) for radiculalgia | Visual analogue scales are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain being 0 equivalent to no pain and 100 to the worst possible pain between Day 1 (first day) and Day 4, Day 1 corresponding to the first administered dose of the treatment (Gabapentin or Placebo). | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with at least one adverse event | Rate of patients with at least one adverse event (all types and grades) between Day 1 and Day 7: According to the National Cancer Institute Common terminology criteria for adverse events (NCI CTCAE) v4.0 | Day 7 |
| Change in VAS for lumbalgia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Ducoulombier, MD | GHICL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Arras-rheumatology | Arras | France | ||||
| CH Béthune-rheumatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41137125 | Result | Ducoulombier V, Coquerelle P, Candelier JB, Avenel G, Leroy R, Juilliard A, Norberciak L, Pascart T. Gabapentin versus placebo for the treatment of acute lumbosacral radicular pain caused by disc herniation: study protocol of the GRADE randomized controlled double-blind superiority trial. Trials. 2025 Oct 24;26(1):435. doi: 10.1186/s13063-025-09139-4. |
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|
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| PLACEBO | Drug | The patient will receive in addition to the usual analgesic treatment, the Placebo During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be made. The patient will have to take the treatment as follows:
|
|
Change in VAS between Day 1 and Day 4. |
| 72 hours |
| Responder rate for lumbalgia at Day 4. | A responder is considered when VAS for low back pain is < 40/100 | Day 4 |
| VAS for radiculalgia | Day 7 |
| VAS for lumbalgia | Day 7 |
| Neuropathic Pain Symptom Inventory (NPSI) scale | The presence of neuropathic pain will be evaluated by the Neuropathic Pain Symptom Inventory (NPSI) scale. This is a self-questionnaire.The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.Evolution of the NPSI (Neuropathic Pain Symptom Inventory) between Day 1 and Day 4, then between Day 1 and Day 7 | Day 7 |
| Dn4 (neuropathic pain screening questionnaire) | In the Dn4 questionnaire there are 4 questions with 10 items. Answers are yes or not. At the end of the questionnaire each "no" is considered as 0, each "yes" is considered as 1. The total score is 10. When addition of answers is 4 or more the test is considered as positive. | Day 7 |
| Number of interdose of anti-nociceptive analgesics | Number of interdose of anti-nociceptive analgesics between Day 1 and Day 4. | Day 4 |
| Rate of patients having used at least one interdose | Rate of patients having used at least one interdose between Day 1 and Day 4 | Day 4 |
| Rate of patients having reduced the associated anti-nociceptive analgesic treatment | Rate of patients having reduced the associated anti-nociceptive analgesic treatment (decrease in dosage or step or stop) between Day 4 and and Day 7. | Day 7 |
| Béthune |
| France |
| CHU Caen-rheumatology | Caen | France |
| CH Dunkerque-rheumatology | Dunkirk | France |
| CHU Rouen-rheumatology | Rouen | France |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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