Botulinum Toxin Type A in Diabetic Peripheral Neuropathy
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: botulinum toxin A injection botulinum toxin A injection |
Drug: botulinum toxin A
botulinum toxin A injection
|
Active Comparator: gabapentin gabapentin |
Drug: Gabapentin
Gabapentin oral intake
|
Active Comparator: duloxetine duloxetine |
Drug: Duloxetine
Duloxetine oral drug intake
|
Outcome Measures
Primary Outcome Measures
- visual analogue score [1 week ,4 weeks,12 weeks]
change visual analogue score zero no pain ,10 unbearable pain
- Pittsburgh sleep quality index [1 week ,4 weeks,12 weeks]
change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | faculty of medicine Alexandria university | Alexandria | Egypt |
Sponsors and Collaborators
- Alexandria University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2217