Injection of Subcutaneous Glucose 10% in Small Shots is Effective in the Treatment of Diabetic Neuropathic Pain
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Observational cohort prospective study with the following of 100 patients of type 1 and type 2 diabetes mellitus in 2 groups each group 50 patients, each group 30 males, and 20 females,35 patients with type 2 diabetes and 15 patients type 1 diabetes all have diabetic peripheral neuropathy, the second group is considered as control. the ages of all patients are between 20 and 50 years.
The first group was on subcutaneous glucose 0.5 ml per site around subcutaneous nerves in the foot region both on palm and sole.which is repeated every 2 weeks for 2 months.
Pain severity was evaluated by using the Visual Analogue Scale (VAS) which is a numerical rating scales, with a straight horizontal line of 100 mm. which is directed from the left with severe pain to the right with no pain. 1-3 = mild pain,4-6 = moderate pain,7-10 = severe pain.
The evaluation of neuropathy was done by using the Michigan Neuropathy Screening Instrument (MNSI) after translation to the Arabic language.which consists a 15 self-administered questionnaires and examination lower extremities which comprise inspection and examination of vibratory senses and ankle reflexes. A score which is more than 7 was suggested to be abnormal.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Cairo, Egypte, 11759
- Mahmoud Younis
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- patients 20 years to 50 years with type 1 or type 2 diabetes who have symptoms of symmetrical peripheral neuropathic pain.
- female Patients are not pregnant.
- Patient has a pain score of at least 5 on the Visual Analogue Scale (VAS).
- Patients are on their antidiabetes medication.
- patents are not on any medication for peripheral neuropathy.
- Patient must be able to complete questions on the Michigan Neuropathy Screening Instrument (MNSI).
Exclusion Criteria:
- Patient has conditions that could affect the evaluation of painful DPN, or non-diabetic neurologic disorders.
- Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
- Patient with history of drug abuse.
- patients on any drug for diabetic neuropathy like pregabalin or gabapentin. No side effects were monitored during the period of treatment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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on subcutaneous glucose
this group was on subcutaneous glucose 0.5 ml per site around subcutaneous nerves in the foot region both on palm and sole.which is repeated every 2 weeks for 2 months.
|
subcutaneous glucose 0.5 ml per site around subcutaneous nerves
Andere namen:
|
|
control(not receiving treatment)
the second group is considered as control.received
no treatment.
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subcutaneous glucose 0.5 ml per site around subcutaneous nerves
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Injection of subcutaneous glucose 10% in small shots is effective in treatment of diabetic neuropathic pain measured the Visual Analogue Scale (VAS)
Tijdsspanne: from baseline to 2 months
|
Pain severity was evaluated by using the Visual Analogue Scale (VAS) which is a numerical rating scale, with a straight horizontal line of 100 mm.
which is directed from the left with severe pain to the right with no pain.
1-3 = mild pain,4-6 = moderate pain,7-10 = severe pain.
|
from baseline to 2 months
|
|
Injection of subcutaneous glucose 10% in small shots is effective in improving neuropathic signs using the Michigan Neuropathy Screening Instrument (MNSI)
Tijdsspanne: from baseline to 2 months
|
The evaluation of neuropathy was done by using the Michigan Neuropathy Screening Instrument (MNSI) after translation to the Arabic language.
Which consists a 15 self-administered questionnaires and examination of lower extremities which comprise inspection and examination of vibratory senses and ankle reflexes.
A score which is more than 7 was suggested to be abnormal.
|
from baseline to 2 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- mahmoudyounis
Plan Individuele Deelnemersgegevens (IPD)
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