Intrathecal methylprednisolone for intractable postherpetic neuralgia.

Phase 3

Withdrawn

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

Registration Number: NL-OMON30745

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

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 100 mm visual-analogue scale (VAS) despite conventional therapies.

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 treatment(s).

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<br /><br>months 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 the end of treatment and at each follow-up<br /><br>visit.<br /><br>-Methylprednisolone concentrations in liquor.<br /><br>-interleukin-8 concentrations in liquor.<br /><br>-EQ5D scores just before treatment and at each follow-up visit.<br /><br>-The amount of used rescue medication.<br /><br>-Side-effects. </p><br>