CompletedPhase 2

Adalimumab in Severe and Acute Sciatica

Switzerland61 participantsStarted 2005-05

Plain-language summary

The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is effective in the treatment of severe and acute sciatica.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients older than 18
. Episode of radicular pain in one lower limb for less than 12 weeks.
. Medical evaluation requiring hospitalisation because of pain or functional handicap
. Patients presenting a characteristic leg pain in the L3, L4, L5, or S1 territories plus at least one of the following: :
. Oswestry score greater than 50
. If there is a past history of radicular pain involving the same nerve root, a 6 months interval free of leg pain is required.
. A confirmed herniated disc on usual imaging techniques (CT scan or MRI) in the vicinity of the clinically involved nerve root that has been performed within the last 2 years.
. Written informed consent

Exclusion criteria

. The presence of recent (\<48 hours) severe muscle weakness (\<3/5) or clinical signs of cauda equina compression, requiring immediate surgery.
. Comorbidities such as :

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Leg pain

Timeframe: 6 months

Trial details

NCT IDNCT00470509

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-01

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