Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)

NCT04865042 | Completed Phase 4

• 1 other identifier: RC-P0103
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 5

Brief 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. During the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.

Conditions

Radiculopathy of Lumbosacral Spine Due to Disc Disorder

Keywords

Radiculalgia; Lumbosacral spine; Disc herniation; Gabapentin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Rate of patients with at least one adverse event

  Day 7

• Change in VAS for lumbalgia

  72 hours

• Responder rate for lumbalgia at Day 4.

  Day 4

• VAS for radiculalgia

  Day 7

• VAS for lumbalgia

  Day 7

Study Arms (2)

Gabapentin

EXPERIMENTAL

GABAPENTIN per os\*: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg

Drug: Gabapentin 300mg

Placebo

PLACEBO COMPARATOR

PLACEBO: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg

Drug: PLACEBO

Interventions

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: * 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.

Also known as: NEUROTIN

Gabapentin

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: * 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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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

You may not qualify if:

• Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
• Chronic neuropathic pain in the lower limb affected by radiculalgia,
• 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,
• Hemodialysis patient,
• Body weight \< 50kgs,
• Transplant patient
• Patient under guardianship or curatorship
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (5)

CH Arras-rheumatology

Arras, France

Location

CH Béthune-rheumatology

Béthune, France

Location

CHU Caen-rheumatology

Caen, France

Location

CH Dunkerque-rheumatology

Dunkirk, France

Location

CHU Rouen-rheumatology

Rouen, France

Location

Related Publications (1)

• 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.

  PMID: 41137125 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Vincent Ducoulombier, MD

  GHICL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: February 2, 2022
• Primary Completion: December 5, 2024
• Study Completion: December 9, 2024
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)