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Study on Gabapentin for Treating Nerve Pain in the Leg from Lower Back Pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication gabapentin on people experiencing radicular leg pain, which is a type of nerve pain that originates from the lower back and travels down the leg. The study aims to compare the effectiveness of gabapentin, taken in doses up to 2700 mg per day, with a placebo. Gabapentin is commonly used to treat nerve pain and is being tested here to see how well it can reduce leg pain over a period of six weeks.

Participants in the study will take either gabapentin or a placebo orally in the form of capsules. The study will last for a total of eight weeks, during which the main focus will be on observing changes in the intensity of leg pain. The study will also look at other factors such as changes in back pain, general health, and any side effects that may occur. Additionally, the study will monitor the use of other pain relief medications during this period.

The purpose of this study is to determine if gabapentin can effectively reduce leg pain associated with nerve issues from the spine. By comparing the results between those taking gabapentin and those taking a placebo, researchers hope to gain a better understanding of the potential benefits and any risks associated with using gabapentin for this type of pain. The study is expected to conclude in 2026.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. These include a clinical diagnosis of radicular leg pain from the spine, symptom duration between 1 week and 6 months, and an age range of 18 to 70 years.
The pain must be classified as at least moderate on a severity scale, with a numeric rating score (NRS) of 4 or higher, where 0 represents 'no pain' and 10 represents the worst imaginable pain.
Step 2
Baseline assessment
A baseline assessment is conducted to measure the average leg pain intensity over the last 24 hours using a numeric rating scale (NRS) from 0 to 10.
This assessment helps establish a starting point for evaluating changes in pain levels throughout the study.
Step 3
Medication administration
Participants receive either gabapentin or a placebo. Gabapentin is administered in the form of hard capsules taken orally.
The dosage of gabapentin can be up to 2700 mg per day, and the treatment period lasts for 6 weeks.
Step 4
Weekly assessments
Weekly assessments are conducted to monitor changes in pain levels. These assessments occur at 1, 2, 4, and 6 weeks.
The assessments include measuring maximal leg pain, average back pain, and changes in pain over the last 24 hours using the NRS.
Step 5
Evaluation of additional factors
Additional evaluations include assessing pain-related disability, general health, and changes in work status during the 6-week treatment period.
The occurrence of any adverse events (AEs) or serious adverse events (SAEs) is also monitored and compared between the gabapentin and placebo groups.
Step 6
End of treatment assessment
At the end of the 6-week treatment period, a final assessment is conducted to evaluate the change in average leg pain intensity from baseline.
This assessment helps determine the effectiveness of gabapentin compared to the placebo in reducing leg pain.

Who can join the trial?

15 criteria

You must have a clinical diagnosis of radicular leg pain, which means pain that starts in the spine and travels down the leg.
You need to have at least one symptom and one sign of radicular leg pain:
Symptoms (what you feel):
Pain in a specific pattern along the leg.
Pain below the knee with feelings like burning, sticking, shooting, tingling, or numbness.
Signs (what can be observed):
Reduced feeling in certain areas of the leg.
Allodynia, which means feeling pain from things that usually don't cause pain, in a specific pattern.
Reduced reflexes in specific areas.
Paresis, which means muscle weakness, in specific muscles related to the pain pattern.
An MR-Scan showing root compression that explains the pain.
A positive Straight leg test, which means feeling pain below the knee when the leg is raised less than 45 degrees.
Your symptoms must have lasted between 1 week and 6 months.
Your average leg pain in the last 24 hours must be at least moderate on a pain scale, where 0 means no pain and 10 means the worst pain imaginable.
You must be between 18 and 70 years old.

Who cannot join the trial?

5 criteria

Patients who are not experiencing radicular leg pain. This is a type of pain that travels from the lower back down the leg, often due to nerve irritation.
Patients who are younger than 18 years old or older than 65 years old.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have any other medical condition that might interfere with the study or make it unsafe for them to participate.

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Verified sites

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Aalborg University Hospital
Verified
Aalborg, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark
Rigshospitalet
Verified
Copenhagen, Denmark

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Investigated drugs

Gabapentin is a medication being studied for its potential to relieve sub-acute radicular leg pain. The trial aims to assess how effective gabapentin is in reducing the average leg pain over a period of six weeks.

What is already known about the treatment

Gabapentin – Gabapentin is administered orally in the form of capsules, tablets, or oral solutions. It is currently being studied in clinical trials for its effectiveness in treating sub-acute radicular leg pain. The medication is primarily used to manage nerve pain and seizures. Gabapentin works by affecting the way nerves send messages to the brain, which helps to reduce pain and control seizures. It belongs to the pharmacological class of anticonvulsants.

Investigated diseases

Radicular Leg Pain – Radicular leg pain is a condition characterized by pain that radiates from the lower back down into the leg. This pain is often caused by irritation or compression of a nerve root in the spine. It can result in sharp, shooting pain, numbness, or tingling sensations along the path of the affected nerve. The pain may worsen with certain movements, such as bending or twisting, and can vary in intensity. It is commonly associated with conditions like herniated discs or spinal stenosis. The progression of symptoms can fluctuate, with periods of relief and exacerbation.