Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intrathecal steroids for intractable postherpetic neuralgia: a randomised controlled trial
Acronym
STIP
Study hypothesis
Intrathecal administration of methylprednisolone with lidocaine is more effective than lidocaine alone in the reduction of pain in postherpetic neuralgia (PHN).
Ethics approval
To be submitted as of 11/11/2008
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Postherpetic neuralgia
Intervention
Administration of 60 mg lidocaine (intrathecal) with or without 60 mg methylprednisolone (intrathecal).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Global pain relief at 1-year follow-up.
Secondary outcome measures
1. Global pain relief at the end of treatment and after 4 weeks, 8 weeks, 6 months and 2 years follow-up
2. Reduction of VAS scores for global, burning and lancinating pain, and allodynia at the end of treatment and after 4 weeks, 8 weeks, 6 months, 1 year and 2 years follow-up
3. Reduction of areas of pain and allodynia at the end of treatment and after 4 weeks, 8 weeks, 6 months, 1 year and 2 years follow-up
4. Reduction in mean number of paracetamol tablets consumed per week at the end of treatment and after 4 weeks follow-up
5. Reduction in mean percentage of the maximal dose of NSAIDs used per week at the end of treatment and after 4 weeks follow-up
6. Reduction in the percentage of the initial dose(s) of PHN medication at the end of treatment and after 4 weeks follow-up
7. Euroqol EQ-5D scores just before treatment and at 4 weeks, 8 weeks, 6 months, 1 year and 2 year follow-up visits
Overall trial start date
01/12/2008
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Outpatient, male or female, aged 18 years or older
2. History of PHN for at least 6 months after onset of the vesicular eruption
3. Global pain intensity due to PHN must be at least 40 mm on 100 mm Visual Analogue Scale (VAS) for the last 24 hours despite conventional therapies, as recorded at Visit 1
4. The PHN must be restricted to the dermatomes involved in the original eruption of herpes zoster
5. Patient does not use concomitant medication for PHN, or is using concomitant PHN medication on a stable dose for at least 4 weeks prior to randomisation
6. Patients must be willing and able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
42
Participant exclusion criteria
1. PHN in regions innervated by the trigeminal nerve
2. Previous neurolytic or neurosurgical treatment for PHN (radiofrequency neuroablation [RF] treatment of the dorsal root ganglion is allowed)
3. Patients who have other pain, which could confound the assessment of the neuropathic pain due to PHN
4. Patients with polyneuropathy or other severe neurologic disease (e.g., multiple sclerosis)
5. Patients with diseases accompanied with a severe immunocompromised state (e.g., during chemotherapy, AIDS; HIV is not an exclusion criterion)
6. Use of coumarin anticoagulants
7. Contra-indications for spinal anaesthesia
8. Contra-indications for oral non-steroidal anti-inflammatory drug (NSAID) use
9. Satisfactory pain relief with conventional treatment (including at least one trycyclic antidepressant and at least one anti-epileptic)
10. Adjustments in concomitant PHN medication during the past 4 weeks
11. Previous spinal anaesthesia with steroids for PHN
12. Skin conditions in the area affected by the neuralgia that could alter sensation
13. Clinically significant psychiatric diagnoses, in particular depression, that would impair their reliable participation in this trial
14. Body Mass Index (BMI) >35 kg/m^2
15. Woman of childbearing potential who is not willing or unable to take adequate birth control measures during the study and for at least 6 months after the last injection
16. Pregnant patients and women who are lactating
17. Problems with communication (language, deafness, aphasia)
Recruitment start date
01/12/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU), Department of Perioperative Care and First Aid (DPenS) (Netherlands)
Sponsor details
Postbus 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Medical Centre Utrecht (UMCU), Department of Perioperative Care and First Aid (DPenS) (Netherlands)
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
Basic results (scientific)
Publication list