Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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Background: Diabetes mellitus is commonly complicated by diabetic peripheral neuropathy. Due to common side effects and poor tolerance to medication, poor adherence to medication is common in diabetic peripheral neuropathy. Botulinum toxin A intradermal injection has proved efficacy in cases of diabetic peripheral neuropathy however there is a need to compare its effect with other lines of treatment. The aim of the study was to compare botulinum toxin type a verses conventional oral treatment as a second line treatment of painful diabetic peripheral neuropathy. This study was conducted as a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups. First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with botulinum toxin A.

Detailed Description
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This study is a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups. First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with Botulinum toxin A. Base line Assessment before treatment and follow up assessment as performed The treatment options were explained to the patients and the choice of Botulinum toxin A Intradermal injection was the patient own decision based on inability to be tolerate or adhere to oral treatment.

Official Title
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A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: botulinum toxin A
* Drug: Gabapentin
* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetic patients type 2 were included on single line of treatment with carbamazepine Exclusion Criteria: any sever medical condition that might interfere with the results.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: botulinum toxin A injection<br>botulinum toxin A injection | Drug: botulinum toxin A<br>* botulinum toxin A injection<br>|
| Active Comparator: gabapentin<br>gabapentin | Drug: Gabapentin<br>* Gabapentin oral intake<br>|
| Active Comparator: duloxetine<br>duloxetine | Drug: Duloxetine<br>* Duloxetine oral drug intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue score | change visual analogue score zero no pain ,10 unbearable pain | 1 week ,4 weeks,12 weeks | 
| Pittsburgh sleep quality index | change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance | 1 week ,4 weeks,12 weeks |