Can a drug melt away painful scar tissue after back surgery?
NCT ID NCT00385086
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a drug that blocks TNF-alpha, a protein involved in inflammation and scar formation, can reduce sciatica pain in people who developed spinal scar tissue after back surgery. 38 adults with persistent pain after discectomy received either the drug or a placebo. The main goal was to see if pain levels improved.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TNF-alpha blocker
- What this could lead to
- If it works, this could provide a new treatment option for chronic sciatica caused by scar tissue after back surgery.
- What could go wrong
- This is a small, completed trial with only 38 participants, so results may not apply to everyone. TNF blockers also carry risks like increased infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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38 people
The number who actually took part.
- Start date
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Feb 2007
- Finished
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Dec 2014
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * age over 18 years old * sciatica post discectomy * Pain with VAS \> 40 mm and impossibility to have his usual activity * Surgical discectomy (less than 2 years and more than 6 months) * Painless of more than one month and less than one year after the discectomy * MRI with gadolinium injection of less than 6 months and done more than 6 months after the discectomy * Presence of spinal fibrosis on MRI (hyposignal in T1 enhanced by gadolinium and hypersignal in T2) * failure of epidural injection treatment * absence of tuberculosis * contraception for woman * informed consent Exclusion Criteria: * Chronic psychiatric pathologies not treated * Presence of conflict between nerve root and herniated disc or disc fragments or spinal stenosis * severe cognitives troubles * severe cardiac failure (class III or IV) * Tuberculosis (active or latent), severe infections * Cancers * Allergy reactions to the drug studied * Difficulties to understand french * Patients enrolled in another clinical trial in the past three months * pregnancy, breastfeeding or no contraception
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hopital Cochin
Paris, Paris, 75014, France