Acute Herpes Zoster, Calcitonin, Subcutaneous
Conditions
Brief summary
This prospective randomized controlled study will be conducted to evaluate the effect of adding calcitonin to the standard treatment protocol in patients with acute herpes zoster infection.
Detailed description
Herpes zoster is associated with inflammation of the dorsal root ganglion and peripheral nerves, and this inflammation is considered to be an important causative factor for postherpetic neuralgia. Interventions aimed at reducing this inflammation should therefore be effective in decreasing the likelihood of developing postherpetic neuralgia. Epidural administration of corticosteroids and local anesthetics has been shown to be effective, but is associated with the risk of arachnoiditis. Subcutaneous injection in an outpatient setting may be effective in preventing postherpetic neuralgia and is also considerably safer. Calcitonin has previously been shown to be effective in the management of acute pain following amputation. Also it was used in a previous study to prevent complex regional pain syndrome in severe hemiplegic patients after stroke. Also, a previous case report revealed that IV calcitonin provided immediate and sustained improvement in post herpetic neuralgia for over two months, without adverse effects from the calcitonin therapy. However, no previous trials evaluated the effect of subcutaneous calcitonin as a preventive measure against the development of postherpetic neuralgia. We will conduct this study as we hypothesize that calcitonin therapy in patients with acute herpes zoster may be associated with better acute pain control and therefore may decrease the incidence of postherpetic neuralgia.
Interventions
DRUGCalcitonin
patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks
OTHERSaline
patients will receive subcutaneous saline (1 ml) daily for three weeks.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged ≥ 50 years, with acute herpes zoster infection (rash duration \< 7 days) and moderate to severe pain.
Exclusion criteria
* Coagulation abnormalities * Pre-existing other pain syndrome or psychological disorders. * Severe hepatic, cardiovascular, or renal disorders. * Allergy to calcitonin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postherpetic neuralgia at 3 months after rash onset. | 3 months after onset of acute herpes zoster rash. | A numeric rating scale (NRS) that ranged from 0 for "no pain" to 10 for "worst ever pain will be used to assess the degree of pain. Pain score more than (3) at 3 months after onset of acute herpes zoster rash will be considered positive for the occurrence of postherpetic neuralgia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postherpetic neuralgia. | 6 months after onset of acute herpes zoster rash. | Pain score more than 3. |
| Severity of acute herpes zoster pain. | Up to 1 month after onset of acute herpes zoster rash. | A numeric rating scale (NRS) that ranged from 0 for "no pain" to 10 for "worst ever pain will be used to assess the degree of pain. |
| Number of medications used to treat pain. | up to 6 months after onset of acute herpes zoster rash. | Analgesics, anti-neuropathic pain medications and opioids will be recorded. |
| Side effects | Up to 1 month after onset of acute herpes zoster rash. | Vomiting |
Countries
Egypt
Contacts
CONTACTAmira M Elkeblawy, MD
Outcome results
None listed