Clinical phenotyping of postherpetic neuralgia patients to optimize pain treatment.
- Conditions
- pain after shinglespostherpetic neuralgia10034606
- Registration Number
- NL-OMON54722
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
- Aged 18 years or older.
- Diagnosed by a physicians with a herpes zoster skin rash.
- Pain in the dermatomes involved in the original eruption of herpes zoster.
- Able and willing to give written informed consent
- Patients with previous neurolytic or neurosurgical treatment for PHN.
(Radiofrequency treatment of the DRG is allowed).
- Patients receiving pain treatment by topical capsaicin 8% in the last 6
months
- Patients who have other types of pain, which could confound the assessment of
the neuropathic pain due to PHN.
- Patients with polyneuropathy or severe other neurologic disease that might
affect outcome measures.
- Patients with skin conditions in the area affected by the neuralgia that
could alter sensation.
- Patients with major cognitive or psychiatric disorders.
- Problems with communication (language, deafness, aphasia etc.)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: The main study parameters are immunological<br /><br>and metabolic parameters in plasma and CSF, skin nerve fiber density<br /><br>measurements, questionnaires, and QST. We will determine whether the addition<br /><br>of these main study parameters identifies other/additional clinical phenotypes<br /><br>than those identified with QST alone and with which minimal parameter datasets<br /><br>these subsets can be identified. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is effect of standard pain treatment for PHN within<br /><br>patient groups with the different clinical phenotypes expressed as decrease in<br /><br>numeric rating scale (NRS), global perceived effect (GPE), time to treatment<br /><br>effect, regain of function, quality of life and improvement of QST parameters<br /><br>assessed at one year follow up. Spinal immunological parameters and metabolites<br /><br>will be assessed with MRS in a subset of patients who provided additional<br /><br>informed consent. Individual methadone metabolism is assessed by determining<br /><br>CYP2B6 enzyme polymorphisms. </p><br>