Intrathecal methylprednisolone for intractable postherpetic neuralgia.

Phase 3

Completed

Conditions: 10041543
Zoster Associated Pain. A garb of roses from hell.

Registration Number: NL-OMON31764

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

-Adult outpatients with a history of postherpetic neuralgia (PHN) for at least 6 months after onset of the vesicular eruption.
-Global pain intensity at least 40 mm on a 100 mm visual-analogue scale (VAS) despite conventional therapy.

Exclusion Criteria

-PHN in regions innervated by the trigeminal nerve.
-Polyneuropathy or severe other neurologic disease.
-Diseases accompanied with an immunocompromised state.
-Disorders of coagulation (including use of coumarin anticoagulants).
-Contra-indications for spinal anesthesia.
-Satisfactory pain relief with conventional treatments(s).
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Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Global pain relief 1 year after treatment tested by VAS scores. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Global pain relief at the end of treatment and after 4 weeks, 8 weeks, 6 months<br /><br>and 2 years.<br /><br>VAS scores for burning and lancinating pain, and allodynia at the end of<br /><br>treatment and at each follow-up visit.<br /><br>Areas of pain and allodynia at at the end of treatment and at each follow-up<br /><br>visit.<br /><br>Methylprednisolone concentrations in cerebrospinal fluid. (Part I)<br /><br>Interleukin-8 concentrations in cerebrospinal fluid.<br /><br>EQ5D scores just before treatment and at each follow-up visit.<br /><br>The amount of rescue medication used.<br /><br>Side-effects. </p><br>