Back to resultsShort-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE) (GRADE)
Primary Purpose
Radiculopathy of Lumbosacral Spine Due to Disc Disorder
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Gabapentin 300mg
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Radiculopathy of Lumbosacral Spine Due to Disc Disorder focused on measuring Radiculalgia, Lumbosacral spine, Disc herniation, Gabapentin
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
- History of pre-existing 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,
- Hemodialysis patient,
- Body weight < 50kgs,
- Transplant patient
- Patient under guardianship or curatorship
- Pregnant or breastfeeding woman
Sites / Locations
- CH Arras-rheumatologyRecruiting
- CH Béthune-rheumatologyRecruiting
- CHU Caen-rheumatologyRecruiting
- CH Dunkerque-rheumatologyRecruiting
- CHU Rouen-rheumatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
GABAPENTIN per os*: DAY 1:300 mg DAY 2: 600 mg DAY 3: 900 mg
PLACEBO: DAY 1:300 mg DAY 2: 600 mg DAY 3: 900 mg
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
Change in VAS for lumbalgia
Change in VAS between Day 1 and Day 4.
Responder rate for lumbalgia at Day 4.
A responder is considered when VAS for low back pain is < 40/100
VAS for radiculalgia
VAS for lumbalgia
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
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.
Number of interdose of anti-nociceptive analgesics
Number of interdose of anti-nociceptive analgesics between Day 1 and 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
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.
Full Information
NCT ID
NCT04865042
First Posted
April 27, 2021
Last Updated
June 21, 2023
Sponsor
Lille Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT04865042
Brief Title
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
Acronym
GRADE
Official Title
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy of Lumbosacral Spine Due to Disc Disorder
Keywords
Radiculalgia, Lumbosacral spine, Disc herniation, Gabapentin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
GABAPENTIN per os*:
DAY 1:300 mg
DAY 2: 600 mg
DAY 3: 900 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PLACEBO:
DAY 1:300 mg
DAY 2: 600 mg
DAY 3: 900 mg
Intervention Type
Drug
Intervention Name(s)
Gabapentin 300mg
Other Intervention Name(s)
NEUROTIN
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analogical Scale (VAS) for radiculalgia
Description
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).
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Rate of patients with at least one adverse event
Description
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
Time Frame
Day 7
Title
Change in VAS for lumbalgia
Description
Change in VAS between Day 1 and Day 4.
Time Frame
72 hours
Title
Responder rate for lumbalgia at Day 4.
Description
A responder is considered when VAS for low back pain is < 40/100
Time Frame
Day 4
Title
VAS for radiculalgia
Time Frame
Day 7
Title
VAS for lumbalgia
Time Frame
Day 7
Title
Neuropathic Pain Symptom Inventory (NPSI) scale
Description
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
Time Frame
Day 7
Title
Dn4 (neuropathic pain screening questionnaire)
Description
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.
Time Frame
Day 7
Title
Number of interdose of anti-nociceptive analgesics
Description
Number of interdose of anti-nociceptive analgesics between Day 1 and Day 4.
Time Frame
Day 4
Title
Rate of patients having used at least one interdose
Description
Rate of patients having used at least one interdose between Day 1 and Day 4
Time Frame
Day 4
Title
Rate of patients having reduced the associated anti-nociceptive analgesic treatment
Description
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.
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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,
Hemodialysis patient,
Body weight < 50kgs,
Transplant patient
Patient under guardianship or curatorship
Pregnant or breastfeeding woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Paule LEBITASY
Phone
+33 3 20 22 52 69
Email
urm@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
William's Van Den Berghe
Phone
+33 3 20 22 57 31
Email
VanDenBerghe.Williams@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Ducoulombier, MD
Organizational Affiliation
GHICL
Official's Role
Study Director
Facility Information:
Facility Name
CH Arras-rheumatology
City
Arras
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste CANDELIER, MD
Facility Name
CH Béthune-rheumatology
City
Béthune
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal, MD
Phone
Coquerelle
Facility Name
CHU Caen-rheumatology
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Marcelli
Facility Name
CH Dunkerque-rheumatology
City
Dunkerque
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémy Leroy, MD
Facility Name
CHU Rouen-rheumatology
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Avenel, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
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