Skip to content

Clinical phenotyping of postherpetic neuralgia patients to optimize pain treatment.

Clinical phenotyping of postherpetic neuralgia patients to optimize pain treatment. - Clinical phenotyping of postherpetic neuralgia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54722
Enrollment
200
Registered
2019-06-19
Start date
2020-07-15
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

pain after shingles postherpetic neuralgia

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.)

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: The main study parameters are immunological and metabolic parameters in plasma and CSF, skin nerve fiber density measurements, questionnaires, and QST. We will determine whether the addition of these main study parameters identifies other/additional clinical phenotypes than those identified with QST alone and with which minimal parameter datasets these subsets can be identified.

Secondary

MeasureTime frame
The secondary endpoint is effect of standard pain treatment for PHN within patient groups with the different clinical phenotypes expressed as decrease in numeric rating scale (NRS), global perceived effect (GPE), time to treatment effect, regain of function, quality of life and improvement of QST parameters assessed at one year follow up. Spinal immunological parameters and metabolites will be assessed with MRS in a subset of patients who provided additional informed consent. Individual methadone metabolism is assessed by determining CYP2B6 enzyme polymorphisms.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)