Post Operative Sciatica by Lumbar Spinal FibrosisPhase 3NCT00385086
Lumbar Spinal Fibrosis and TNF Alpha Inhibition
A Phase 3 study testing TNF blocker in people with Post Operative Sciatica by Lumbar Spinal Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Sciatica by Lumbar Spinal Fibrosis
- What is being tested?
- TNF blocker
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
Read the detailed description
OBJECT:
Failed back surgery syndrome is still a challenging therapeutic problem. Clinical studies have demonstrated a significant association between lumbar spinal fibrosis after lumbar discectomy and the recurrence of radicular pain in 25% of cases. Forceful epidural infiltrations, radiotherapy, therapy with D-penicillamine or surgical procedures have had unfavourable results in terms of pain and cost. Magnetic resonance imaging reveals lumbar spinal fibrosis by a hyposignal in the T1 sequence and a hypersignal in T2 sequence around the spinal tissue. Tumor necrosis factor a (TNF-a) is the main cytokine implicated in the formation of tissue fibrosis. In animal models of fibrosis, TNF-a inhibition has been shown to prevent and treat tissue fibrosis.
HYPOTHESIS:
Inhibiting TNF-a could significantly decrease sciatica pain because of lumbar spinal fibrosis after lumbar discectomy by decreasing spinal fibrosis.
METHODS:
We propose a 2-year pilot prospective, randomized, double-blind, controlled study of TNF-a inhibitor (infliximab) in patients with sciatica as a result of postoperative lumbar spinal fibrosis. The infliximab group will receive one intravenous injection of 3 mg/kg infliximab. The control group will receive one physiological serum injection. Patients will be evaluated at day 0, 10, 30, 90, and 180. The main evaluation criterion will be sciatica pain as measured on a visual analog scale, with the objective of a 50% decrease in pain at day 10. This objective leads to a size of 20 patients per group. The other evaluation criteria will be clinical, functional, social, and professional. Patients will be recruited from the rehabilitation unit at Cochin teaching hospital.
- Being tested
- TNF blocker, Placebo
- Keywords
- Sciatica, Pain, TNF-alpha, Discectomy, Fibrosis, Spine
- Medical subject headings
- Sciatica, Pain, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF blockerDrug
Treatment with TNF-alpha blocker
PlaceboDrug
Treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| TNF-alpha blocker | Experimental | Treatment with TNF-alpha blocker Receives: Drug: TNF blocker |
| Placebo | Active comparator | Treatment with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sciatica pain
Visual analogue scale of lumbar pain
Measured: 10 days after treatment
Secondary outcomes (1)
Functional assessments
Measured: At 10, 30, 90, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startFeb 2007
- Primary completionOct 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Sciatica by Lumbar Spinal FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Francois Rannou, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385086
- Sponsor's protocol ID
- P050312
- Status last verified
- Mar 2026
- First submitted
- 4 Oct 2006
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Nguyen C, Palazzo C, Grabar S, Feydy A, Sanchez K, Zee N, Quinquis L, Ben Boutieb M, Revel M, Lefevre-Colau MM, Poiraudeau S, Rannou F. Tumor necrosis factor-alpha blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study. Arthritis Res Ther. 2015 Nov 19;17:330. doi: 10.1186/s13075-015-0838-4.
PubMed 26596627
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis
- ClinicalTrials.gov ID
- NCT00385086
- Acronym / sponsor ID
- P050312
- Keywords
- Sciatica, Pain, TNF-alpha, Discectomy, Fibrosis, Spine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Feb 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
Detailed description
OBJECT:
Failed back surgery syndrome is still a challenging therapeutic problem. Clinical studies have demonstrated a significant association between lumbar spinal fibrosis after lumbar discectomy and the recurrence of radicular pain in 25% of cases. Forceful epidural infiltrations, radiotherapy, therapy with D-penicillamine or surgical procedures have had unfavourable results in terms of pain and cost. Magnetic resonance imaging reveals lumbar spinal fibrosis by a hyposignal in the T1 sequence and a hypersignal in T2 sequence around the spinal tissue. Tumor necrosis factor a (TNF-a) is the main cytokine implicated in the formation of tissue fibrosis. In animal models of fibrosis, TNF-a inhibition has been shown to prevent and treat tissue fibrosis.
HYPOTHESIS:
Inhibiting TNF-a could significantly decrease sciatica pain because of lumbar spinal fibrosis after lumbar discectomy by decreasing spinal fibrosis.
METHODS:
We propose a 2-year pilot prospective, randomized, double-blind, controlled study of TNF-a inhibitor (infliximab) in patients with sciatica as a result of postoperative lumbar spinal fibrosis. The infliximab group will receive one intravenous injection of 3 mg/kg infliximab. The control group will receive one physiological serum injection. Patients will be evaluated at day 0, 10, 30, 90, and 180. The main evaluation criterion will be sciatica pain as measured on a visual analog scale, with the objective of a 50% decrease in pain at day 10. This objective leads to a size of 20 patients per group. The other evaluation criteria will be clinical, functional, social, and professional. Patients will be recruited from the rehabilitation unit at Cochin teaching hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNF-alpha blocker | Experimental | Drug: TNF blockerTreatment with TNF-alpha blocker |
| Placebo | Active comparator | Drug: PlaceboTreatment with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF blockerTreatment with TNF-alpha blocker | Drug | TNF-alpha blocker |
| PlaceboTreatment with placebo | Drug | Placebo |
Primary outcome
Sciatica pain
Time frame: 10 days after treatment
Visual analogue scale of lumbar pain
1 secondary outcome
Functional assessments
Time frame: At 10, 30, 90, 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 26596627Nguyen C, Palazzo C, Grabar S, Feydy A, Sanchez K, Zee N, Quinquis L, Ben Boutieb M, Revel M, Lefevre-Colau MM, Poiraudeau S, Rannou F. Tumor necrosis factor-alpha blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study. Arthritis Res Ther. 2015 Nov 19;17:330. doi: 10.1186/s13075-015-0838-4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Rannou, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TNF blocker in people with Post Operative Sciatica by Lumbar Spinal Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sciatica pain (time frame: 10 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.