Radiculopathy of Lumbosacral Spine Due to Disc DisorderPhase 4GRADENCT04865042
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
A Phase 4 study testing Gabapentin 300mg in people with Radiculopathy of Lumbosacral Spine Due to Disc Disorder, run by Lille Catholic University at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy of Lumbosacral Spine Due to Disc Disorder
- What is being tested?
- Gabapentin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 5 sitesFrance
- Study dates
- 2 Feb 2022to 9 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limb systematized to a radicular territory, possibly associated with lumbar pain),
- Inpatient management for a minimum of 72 hours after inclusion,
- Initial radiculalgia VAS ≥ 4 (moderate to severe pain),
- Concordant disc herniation between clinical symptomatology and imaging (CT or MRI) less than 3 months,
- Written consent signed by the patient,
- Affiliation to a social security system
- For women of childbearing age, use of effective contraception
Who cannot join
- Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
- Chronic neuropathic pain in the lower limb affected by radiculalgia,
- Lumbar infiltration performed within 72 hours prior to inclusion or unable to be performed after 72 hours,
- Patient already on Gabapentin or Pregabalin, or having taken these treatments in the 7 days prior to inclusion
- Contraindication to Gabapentin (Hypersensitivity to the active substance or to any of the excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium lauryl sulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide)
- Creatinine clearance < 30ml/min,
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- Hemodialysis patient,
- Body weight < 50kgs,
- Transplant patient
- Patient under guardianship or curatorship
- Pregnant or breastfeeding woman
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH Arras-rheumatology
Arras
CH Béthune-rheumatology
Béthune
CHU Caen-rheumatology
Caen
CH Dunkerque-rheumatology
Dunkirk
CHU Rouen-rheumatology
Rouen
About this study
Official title: Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study
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.
Read the detailed description
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 :
- Experimental group: GABAPENTINE per os
- DAY1:300 mg
- DAY 2: 600 mg
- DAY3 : 900 mg
- Control group: placebo (same dosage per day as GABAPENTINE).
- Being tested
- Gabapentin 300mg, PLACEBO
- Keywords
- Radiculalgia, Lumbosacral spine, Disc herniation, Gabapentin
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 300mgDrug
Also called NEUROTIN
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:
- Day 1 (1st day of hospitalization): 1 capsule/day
- Day 2: 2 capsules/day
- Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed.
PLACEBODrug
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:
- Day 1 (1st day of hospitalization): 1 capsule/day
- Day 2: 2 capsules/day
- Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | GABAPENTIN per os*:
* DAY 1:300 mg
* DAY 2: 600 mg
* DAY 3: 900 mg Receives: Drug: Gabapentin 300mg |
| Placebo | Placebo comparator | PLACEBO:
* DAY 1:300 mg
* DAY 2: 600 mg
* DAY 3: 900 mg Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 4
Secondary outcomes (10)
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
Measured: Day 7
Change in VAS for lumbalgia
Change in VAS between Day 1 and Day 4.
Measured: 72 hours
Responder rate for lumbalgia at Day 4.
A responder is considered when VAS for low back pain is < 40/100
Measured: Day 4
VAS for radiculalgia
Measured: Day 7
VAS for lumbalgia
Measured: 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
Measured: 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.
Measured: Day 7
Number of interdose of anti-nociceptive analgesics
Number of interdose of anti-nociceptive analgesics between Day 1 and Day 4.
Measured: 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
Measured: 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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start2 Feb 2022
- Primary completion5 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy of Lumbosacral Spine Due to Disc DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Ducoulombier, MD, Study director, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865042
- Sponsor's protocol ID
- RC-P0103
- Acronym
- GRADE
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2021
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41137125
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT04865042
- Acronym / sponsor ID
- GRADE / RC-P0103
- Keywords
- Radiculalgia, Lumbosacral spine, Disc herniation, Gabapentin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 :
- Experimental group: GABAPENTINE per os
- DAY1:300 mg
- DAY 2: 600 mg
- DAY3 : 900 mg
- Control group: placebo (same dosage per day as GABAPENTINE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin 300mgGABAPENTIN per os*: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg |
| Placebo | Placebo comparator | Drug: PLACEBOPLACEBO: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years,
- Radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limb systematized to a radicular territory, possibly associated with lumbar pain),
- Inpatient management for a minimum of 72 hours after inclusion,
- Initial radiculalgia VAS ≥ 4 (moderate to severe pain),
- Concordant disc herniation between clinical symptomatology and imaging (CT or MRI) less than 3 months,
Key exclusion criteria (11 listed)
- Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
- Chronic neuropathic pain in the lower limb affected by radiculalgia,
- Lumbar infiltration performed within 72 hours prior to inclusion or unable to be performed after 72 hours,
- Patient already on Gabapentin or Pregabalin, or having taken these treatments in the 7 days prior to inclusion
- Contraindication to Gabapentin (Hypersensitivity to the active substance or to any of the excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium lauryl sulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin 300mgAlso: NEUROTINThe 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: * Day 1 (1st day of hospitalization): 1 capsule/day * Day 2: 2 capsules/day * Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed. | Drug | Gabapentin |
| PLACEBOThe 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: * Day 1 (1st day of hospitalization): 1 capsule/day * Day 2: 2 capsules/day * Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed. | Drug | Placebo |
Primary outcome
Change in Visual Analogical Scale (VAS) for radiculalgia
Time frame: Day 4
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).
10 secondary outcomes
Rate of patients with at least one adverse event
Time frame: Day 7
Change in VAS for lumbalgia
Time frame: 72 hours
Responder rate for lumbalgia at Day 4.
Time frame: Day 4
VAS for radiculalgia
Time frame: Day 7
VAS for lumbalgia
Time frame: Day 7
Neuropathic Pain Symptom Inventory (NPSI) scale
Time frame: Day 7
Dn4 (neuropathic pain screening questionnaire)
Time frame: Day 7
Number of interdose of anti-nociceptive analgesics
Time frame: Day 4
Rate of patients having used at least one interdose
Time frame: Day 4
Rate of patients having reduced the associated anti-nociceptive analgesic treatment
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 41137125Ducoulombier 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Ducoulombier, MD study director
GHICL
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin 300mg in people with Radiculopathy of Lumbosacral Spine Due to Disc Disorder, run by Lille Catholic University at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogical Scale (VAS) for radiculalgia (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04865042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.