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SciaticaPhase 1/2NCT00364572

Efficacy of Epidural Etanercept in the Treatment of Sciatica

A Phase 1/2 study testing epidural injection of etanercept in people with Sciatica, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots results in pain behavior indicative of radiculopathy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sciatica
What is being tested?
epidural injection of etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
May 2006to Dec 2007
Phase
Phase 1/2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic low back pain of radicular origin of > 2 months but < 1 year duration.
  • Failure of conservative therapy to include physical and pharmacotherapy.
  • MRI evidence of a herniated disc corresponding to the patient's radicular symptoms.
  • Normal white blood cell count (drawn in 1 blood vial).

Who cannot join

  • Uncontrolled coagulopathy.
  • Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists.
  • Allergy to contrast dye.
  • Unstable medical condition (e.g., unstable angina or congestive heart failure).
  • Rheumatoid arthritis, Crohn's disease or spondylarthropathy.
  • Unstable neurological condition (e.g., multiple sclerosis)
  • Systemic infection
  • Age < 18 or > 70 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307

Other trials in United States

About this study

Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior. Open-label studies in humans have shown both etanercept and infliximab provide excellent, long-term relief in patients with acute radiculopathy from herniated disc. However, a recent placebo-controlled study failed to demonstrate any significant difference from placebo. The investigators have already established the safety of neuraxial etanercept in a trial that has just been completed (not yet published). The objective of this study is to determine whether small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for LBP caused by nerve root irritation (i.e., radiculopathy).

Read the detailed description

As per the wishes of the Dept. of the Army and Walter Reed Army Medical Center Dept. of Clinical Investigation, patients will be randomized in a 3:1 ratio to receive 2 transforaminal epidural etanercept or saline injections at 2-week intervals. Both patients and physicians will be blinded as to the injectate and treatment group. There will be 3 study groups. Group I will receive either 2 mg of etanercept or saline per injection. Group II will receive either 4 mg of etanercept or saline per injection. Group III will receive either 6 mg of etanercept or saline per injection. In each group there will be 8 patients: 6 who receive etanercept and 2 who receive saline. As per a previous study we just completed, etanercept doses will not be escalated until all 6 patients have completed their 1-month follow-up visits without any evidence of toxicity or complications.

Conditions
Sciatica
Being tested
epidural injection of etanercept, placebo (control procedure)
Keywords
sciatica, low back pain, epidural, tumor necrosis factor
Medical subject headings
Sciatica, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epidural injection of etanerceptDrug

    2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg

  • placebo (control procedure)Drug

    Two injections of epidural saline 2 weeks apart

Study groups in NCT00364572
Study groupRoleWhat they receive
1Placebo comparatorTwo injections of epidural saline 2 weeks apart
Receives: Drug: placebo (control procedure)
Epidural injection of etanerceptExperimentalTwo injections of epidural etanercept 2 weeks apart
Receives: Drug: epidural injection of etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue scale pain score, Oswestry disability index, medication intake

    Measured: 7 months

Secondary outcomes (1)

  1. Global perceived effect, white blood cell count

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00364572
Sponsor's protocol ID
WU#06-20009A
Status last verified
Jan 2009
First submitted
14 Aug 2006
Last updated
22 Jan 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Ozaktay AC, Cavanaugh JM, Asik I, DeLeo JA, Weinstein JN. Dorsal root sensitivity to interleukin-1 beta, interleukin-6 and tumor necrosis factor in rats. Eur Spine J. 2002 Oct;11(5):467-75. doi: 10.1007/s00586-002-0430-x. Epub 2002 Jun 4.

    PubMed 12384756

  • Olmarker K, Larsson K. Tumor necrosis factor alpha and nucleus-pulposus-induced nerve root injury. Spine (Phila Pa 1976). 1998 Dec 1;23(23):2538-44. doi: 10.1097/00007632-199812010-00008.

    PubMed 9854752

  • Olmarker K, Nutu M, Storkson R. Changes in spontaneous behavior in rats exposed to experimental disc herniation are blocked by selective TNF-alpha inhibition. Spine (Phila Pa 1976). 2003 Aug 1;28(15):1635-41; discussion 1642. doi: 10.1097/01.BRS.0000083162.35476.FF.

    PubMed 12897484

  • Igarashi T, Kikuchi S, Shubayev V, Myers RR. 2000 Volvo Award winner in basic science studies: Exogenous tumor necrosis factor-alpha mimics nucleus pulposus-induced neuropathology. Molecular, histologic, and behavioral comparisons in rats. Spine (Phila Pa 1976). 2000 Dec 1;25(23):2975-80. doi: 10.1097/00007632-200012010-00003.

    PubMed 11145807

  • Korhonen T, Karppinen J, Malmivaara A, Autio R, Niinimaki J, Paimela L, Kyllonen E, Lindgren KA, Tervonen O, Seitsalo S, Hurri H. Efficacy of infliximab for disc herniation-induced sciatica: one-year follow-up. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2115-9. doi: 10.1097/01.brs.0000141179.58778.6c.

    PubMed 15454701

  • Korhonen T, Karppinen J, Paimela L, Malmivaara A, Lindgren KA, Jarvinen S, Niinimaki J, Veeger N, Seitsalo S, Hurri H. The treatment of disc herniation-induced sciatica with infliximab: results of a randomized, controlled, 3-month follow-up study. Spine (Phila Pa 1976). 2005 Dec 15;30(24):2724-8. doi: 10.1097/01.brs.0000190815.13764.64.

    PubMed 16371894

  • Genevay S, Stingelin S, Gabay C. Efficacy of etanercept in the treatment of acute, severe sciatica: a pilot study. Ann Rheum Dis. 2004 Sep;63(9):1120-3. doi: 10.1136/ard.2003.016451. Epub 2004 Apr 28.

    PubMed 15115710

  • Cohen SP, Griffith S, Larkin TM, Villena F, Larkin R. Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in Operation Iraqi Freedom: an epidemiological study conducted at two military pain management centers. Anesth Analg. 2005 Oct;101(4):1098-1103. doi: 10.1213/01.ane.0000169332.45209.cf.

    PubMed 16192528

  • Cohen SP, Bogduk N, Dragovich A, Buckenmaier CC 3rd, Griffith S, Kurihara C, Raymond J, Richter PJ, Williams N, Yaksh TL. Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica. Anesthesiology. 2009 May;110(5):1116-26. doi: 10.1097/ALN.0b013e3181a05aa0.

    PubMed 19387178

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing epidural injection of etanercept in people with Sciatica, run by Johns Hopkins University at 1 site in United States.

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 4 inclusion and 8 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 22 Jan 2009. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Visual analogue scale pain score, Oswestry disability index, medication intake (time frame: 7 months). 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 NCT00364572, which also lists 9 linked publications.

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 22 Jan 2009.

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