Intrathecal steroids for intractable postherpetic neuralgia

ISRCTN ISRCTN88145753
DOI https://doi.org/10.1186/ISRCTN88145753
Secondary identifying numbers N/A
Submission date
11/11/2008
Registration date
19/02/2009
Last edited
31/03/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A J M van Wijck
Scientific

University Medical Centre Utrecht
Postbus 85500
Utrecht
3508 GA
Netherlands

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleIntrathecal steroids for intractable postherpetic neuralgia: a randomised controlled trial
Study acronymSTIP
Study objectivesIntrathecal administration of methylprednisolone with lidocaine is more effective than lidocaine alone in the reduction of pain in postherpetic neuralgia (PHN).
Ethics approval(s)To be submitted as of 11/11/2008
Health condition(s) or problem(s) studiedPostherpetic neuralgia
InterventionAdministration of 60 mg lidocaine (intrathecal) with or without 60 mg methylprednisolone (intrathecal).
Intervention typeOther
Primary outcome measureGlobal pain relief at 1-year follow-up.
Secondary outcome measures1. 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 study start date01/12/2008
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants42
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/12/2008
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU), Department of Perioperative Care and First Aid (DPenS) (Netherlands)
University/education

Postbus 85500
Utrecht
3508 GA
Netherlands

http://www.umcutrecht.nl
ROR logo https://ror.org/04pp8hn57

Funders

Funder type

University/education

University Medical Centre Utrecht (UMCU), Department of Perioperative Care and First Aid (DPenS) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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