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
-
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.
-
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.