Intrathecal steroids for intractable postherpetic neuralgia

Completed

• Conditions: Postherpetic neuralgia; Infections and Infestations; Zoster [herpes zoster]

• Registration Number: ISRCTN88145753
• Lead Sponsor: niversity Medical Centre Utrecht (UMCU), Department of Perioperative Care and First Aid (DPenS) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified