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Study on Gabapentin and Placebo for Short-Term Relief of Acute Lower Back Pain from Herniated Disc in Adults

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What is this study about?

This clinical trial is focused on studying the short-term effectiveness of the medication Gabapentin compared to a placebo in treating acute lumbosacral radiculopathy, which is a type of nerve pain caused by a herniated disc in the lower back. The purpose of the study is to evaluate how well Gabapentin can relieve pain in this condition.

Participants in the study will receive either Gabapentin or a placebo. The study will monitor changes in pain levels over a short period, specifically from the first day of treatment to the fourth day. The study will also observe any side effects that participants may experience during the first week of treatment. The goal is to determine if Gabapentin is effective in reducing pain compared to the placebo.

The study will involve regular assessments of pain and any side effects experienced by participants. These assessments will help researchers understand the impact of Gabapentin on pain relief and its safety profile. The study is designed to provide valuable information on the potential benefits of using Gabapentin for managing acute nerve pain due to a herniated disc.

1 joining the study

Upon joining the study, you will be required to provide written consent, confirming your understanding and agreement to participate.

You must meet specific criteria, such as being 18 years or older, experiencing radiculalgia for less than 3 months, and having a confirmed disc herniation through imaging.

2 initial assessment

An initial assessment will be conducted to evaluate your pain level using the Visual Analogue Scale (VAS), which measures pain intensity on a scale from 0 to 100.

You will be required to stay in the hospital for at least 72 hours after this assessment.

3 treatment administration

You will be randomly assigned to receive either Gabapentin or a placebo. Gabapentin is administered in the form of a 300 mg hard capsule taken orally.

The first dose of the treatment will be given on Day 1, marking the start of the treatment period.

4 monitoring and follow-up

Your pain levels will be monitored regularly using the VAS on Days 1, 4, and 7 to assess changes in your condition.

You will also be asked to report any side effects or adverse events you experience during the study period.

5 completion of the study

The study will conclude after the final assessment on Day 7, where your pain levels and any changes in medication use will be evaluated.

The results will help determine the effectiveness of Gabapentin compared to the placebo in managing acute lumbosacral radiculalgia.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have had lumbosacral radiculalgia (pain in the lower back and leg) for less than 3 months.
  • Must stay in the hospital for at least 72 hours after joining the study.
  • Must have a pain level of 4 or higher on a scale called VAS, which measures pain from moderate to severe.
  • Must have a disc herniation (a problem with the discs in the spine) that matches the symptoms and is confirmed by a scan (CT or MRI) done in the last 3 months.
  • Must provide written consent to participate in the study.
  • Must be part of a social security system.
  • If a woman of childbearing age, must use effective contraception to prevent pregnancy.

Who Cannot Join the Study?

  • Patients with any other significant medical condition that could interfere with the study.
  • Patients who are currently taking medications that might affect the study results.
  • Patients who have had surgery related to the spine in the past 6 months.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of allergic reactions to the study medication.
  • Patients who are participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Bethune Beuvry Beuvry France
Centre Hospitalier de Dunkerque Dunkirk France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Cvlczx Hnzwltzjntc dx Dpcam Douai France
Cohwhx Hcbchlkpqqu Dkaqnmzbxecvx Arras France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
09.02.2022

Trial locations

Investigated drugs:

Gabapentin is a medication that is often used to help relieve nerve pain. In this clinical trial, it is being tested to see how well it can reduce pain in people who have acute Lumbosacral Radiculalgia, which is a type of back pain caused by a herniated disc. The goal is to find out if Gabapentin can effectively reduce pain in the short term for people suffering from this condition.

Investigated diseases:

Lumbosacral Radiculopathy – Lumbosacral radiculopathy is a condition characterized by pain that radiates from the lower back down to the legs, often due to nerve root irritation or compression. This condition typically arises from a herniated disc in the lumbar spine, which can press on the nerve roots. The progression of symptoms may include sharp or burning pain, numbness, tingling, or muscle weakness in the affected areas. As the condition advances, these symptoms can fluctuate in intensity and may be aggravated by certain movements or positions. Over time, the pain may become more persistent, and the range of motion in the lower back can be reduced. The condition can affect daily activities, depending on the severity of nerve involvement.

Trial ID:
2024-518053-42-00
Protocol code:
RC-P0103
NCT ID:
NCT04865042
Trial Phase:
Therapeutic confirmatory (Phase III)

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