Condition category
Infections and Infestations
Date applied
23/10/2003
Date assigned
24/11/2003
Last edited
31/03/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Theo Verheij

ORCID ID

Contact details

Julius Center for Health Sciences and Primary Care
University Medical Center
PO Box 85060
Utrecht
3500 AB
Netherlands
+31 (0)30 253 8188
T.J.M.Verheij@med.uu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NWO 945-02-009

Study information

Scientific title

Acronym

PINE

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Herpes zoster/postherpetic neuralgia

Intervention

Index group: Standard treatment (antiviral and analgesic medication) plus epidural injection of local anaesthetics and corticosteroids.

Control group: Standard treatment (antiviral and analgesic medication)

Intervention type

Drug

Phase

Not Specified

Drug names

Methylprednisolone-acetate, bupivacaine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Elderly patients (age >50 years) with acute herpes zoster (skin lesions <7 days) below dermatome C6 in primary care

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

550

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2004

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Julius Center for Health Sciences and Primary Care
Utrecht
3500 AB
Netherlands

Sponsor information

Organisation

Julius Center for Health Sciences and Primary Care (The Netherlands)

Sponsor details

University Medical Center
Utrecht
PO Box 85060
Utrecht
3500 AB
Netherlands
+31 (0)30 253 8788
w.opstelten@med.uu.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Scientific Research (The Netherlands) (ref: 945-02-009)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15005813

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=16427490

Publication citations

  1. Protocol

    Opstelten W, Van Wijck AJ, Van Essen GA, Buskens E, Bak AA, Kalkman CJ, Verheij TJ, Moons KG, The PINE study: rationale and design of a randomised comparison of epidural injection of local anaesthetics and steroids versus care-as-usual to prevent postherpetic neuralgia in the elderly [ISRCTN32866390]., BMC Anesthesiol, 2004, 4, 1, 2, doi: 10.1186/1471-2253-4-2.

  2. Results

    van Wijck AJ, Opstelten W, Moons KG, van Essen GA, Stolker RJ, Kalkman CJ, Verheij TJ, The PINE study of epidural steroids and local anaesthetics to prevent postherpetic neuralgia: a randomised controlled trial., Lancet, 2006, 367, 9506, 219-224, doi: 10.1016/S0140-6736(06)68032-X.

Additional files

Editorial Notes