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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitonin group | Experimental | patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks. |
|
| Control group | Placebo Comparator | patients will receive subcutaneous saline (1 ml) daily for three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitonin | Drug | patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postherpetic neuralgia at 3 months after rash onset. | 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. | 3 months after onset of acute herpes zoster rash. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postherpetic neuralgia. | Pain score more than 3. | 6 months after onset of acute herpes zoster rash. |
| Severity of acute herpes zoster pain. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amira M Elkeblawy, MD | Contact | 01148529429 | 002 | marmoramero999@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbia Governorate | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author.
After completion of the study.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D002116 | Calcitonin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013963 | Thyroid Hormones |
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Parallel assignment
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Double blind
| Saline | Other | patients will receive subcutaneous saline (1 ml) daily for three weeks. |
|
| Up to 1 month after onset of acute herpes zoster rash. |
| Number of medications used to treat pain. | Analgesics, anti-neuropathic pain medications and opioids will be recorded. | up to 6 months after onset of acute herpes zoster rash. |
| Side effects | Vomiting | Up to 1 month after onset of acute herpes zoster rash. |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |