Subcutaneous Calcitonin in Acute Herpes Zoster
The Prophylactic Value of Subcutaneous Calcitonin in Acute Herpes Zoster Patients: A Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Amira M Elkeblawy, MD
- Telefonnummer: 002 01148529429
- E-post: marmoramero999@gmail.com
Studieorter
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-
Gharbia Governorate
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Tanta, Gharbia Governorate, Egypten, 31527
- Rekrytering
- Tanta University Hospitals
-
Kontakt:
- Amira M Elkeblawy, MD
- Telefonnummer: 002 01148529429
- E-post: marmoramero999@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Calcitonin group
patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks.
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patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks
|
|
Placebo-jämförare: Control group
patients will receive subcutaneous saline (1 ml) daily for three weeks.
|
patients will receive subcutaneous saline (1 ml) daily for three weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of postherpetic neuralgia at 3 months after rash onset.
Tidsram: 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.
|
3 months after onset of acute herpes zoster rash.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of postherpetic neuralgia.
Tidsram: 6 months after onset of acute herpes zoster rash.
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Pain score more than 3.
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6 months after onset of acute herpes zoster rash.
|
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Severity of acute herpes zoster pain.
Tidsram: 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.
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Up to 1 month after onset of acute herpes zoster rash.
|
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Number of medications used to treat pain.
Tidsram: up to 6 months after onset of acute herpes zoster rash.
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Analgesics, anti-neuropathic pain medications and opioids will be recorded.
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up to 6 months after onset of acute herpes zoster rash.
|
|
Side effects
Tidsram: Up to 1 month after onset of acute herpes zoster rash.
|
Vomiting
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Up to 1 month after onset of acute herpes zoster rash.
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 36265PR14/4/26
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IPD-delning som stöder informationstyp
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