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Intrathecal methylprednisolone for intractable postherpetic neuralgia.

Intrathecal methylprednisolone for intractable postherpetic neuralgia. - STIP (STeroids for Intractable Postherpetic neuralgia).

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31764
Enrollment
42
Registered
2008-02-19
Start date
2008-11-06
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zoster Associated Pain. A garb of roses from hell.

Interventions

For 2 weeks (the prestudy period) patients are treated with paracetamol and NSAIDs. During this period (and afterward) concomitant PHN medication maintained on a stable dose is allowed. After this p

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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). -

Design outcomes

Primary

MeasureTime frame
Global pain relief 1 year after treatment tested by VAS scores.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)