The effect of transdermal nitroglycerin on pain control of painful peripheral diabetic neuropathy: A crossover, double-blinded and placebo-controlled study
In this crossover study 30 patients with painful peripheral diabetic neuropathy over 18 years of age will randomly allocate to two groups of drug and placebo which will receive nitroglycerin plasters and placebo patches for 4 weeks. Then they will a 3 week course of washout period and thereafter they will be treated by the compund of the other group (drug or placebo) for another 4 week period. Pain intensity as the primary outcome of the study will be assessed by NRS score. Secondary outcomes and their measurement tools will be: patient`s physical functioning (SF-36 Health Survey and BPI), psychological and emotional status of the patients (BDI), the sense of well-being and satisfaction (PGIC), frequency and severity of treatment related side effects. These data will compared in two phases of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308223213N1
Registration date:2013-10-03, 1392/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-03, 1392/07/11
Registrant information
Name
Arash Farbood
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
farboda@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research budget of Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences
Expected recruitment start date
2012-04-24, 1391/02/05
Expected recruitment end date
2013-03-02, 1391/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transdermal nitroglycerin on pain control of painful peripheral diabetic neuropathy: A crossover, double-blinded and placebo-controlled study
Public title
Effect of transcutaneous nitroglycerin on painful diabetic neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: more than 18 years of age ; history of type 1 or 2 diabetes ; Hb A1c level below 8.5% ; symptoms of symmetrical peripheral neuropathy in distal lower extremities ; pain severity more than 4 of 10 in NRS scale at the begining of the study ; the patients` willingness, knowledge and ability for participation
Exclusion criteria: patients with ischemic heart and lower extremity peripheral arterial disease ; patients with diabetic foot ulcers ; patients with history of peripheral neuropathies from other causes (e.g. hypothyroidism, vitamin B12 or folate deficiency, sarcoidosis and alcoholism) ; patients who receive vasodilating compounds like nitroglycerine and sildenafil
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Diabetes Research Center/Institute of Endocrinology and Metabolism/Tehran University of Medical Scie
Street address
Diabetes Research Center, 5th floor, Diabetes and Metabolic Disease clinic, next to the Tehran Heart Center Emergency Department, Heyaat Alley, Western 17th Shahrivar Avenue, Northren Kargar Street, Amirabad
City
Tehran
Postal code
Approval date
2011-08-27, 1390/06/05
Ethics committee reference number
00185
Health conditions studied
1
Description of health condition studied
Diabetic polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
Pain intensity
Timepoint
2 times weekly
Method of measurement
Numerical Rating Scale
Secondary outcomes
1
Description
Patient`s physical functioning
Timepoint
Once after each phase of treatment (with drug and placebo)
Method of measurement
SF-36 and BPI questionnaires
2
Description
Psychological and emotional status of the patients
Timepoint
Once after each phase of treatment (with drug and placebo)
Method of measurement
BDI
3
Description
Patient`s global satisfaction and sense of well-being
Timepoint
Once after each phase of treatment (with drug and placebo)
Method of measurement
PGIC questionnaire
4
Description
Frequency and severity of treatment related side effects
Timepoint
Once a week during the treatment phases
Method of measurement
Frequency and severity measurement
Intervention groups
1
Description
In the study group the patients will be asked to apply 0.2 mg/hr transcutaneous nitroglycerin plasters ( Nitro-Dur, Schering-Plough Pty Ltd., Australia) for 12 hours daily and for 4 weeks.
Category
Treatment - Drugs
2
Description
In the placebo group the patients will be asked to apply transcutaneous placebo plasters for 12 hours daily and for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes & Metabolic Diseases Clinic/ Endocrinology & Metabolism Research Istitute/Tehran University
Full name of responsible person
Ghazaleh Ebrahimi Khaneqah, MD
Street address
Next to the Tehran Heart Center Emergency Department, Shahrivar Alley, Northren Kargar Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Diabetes Research Center/Institute of Endocrinology and Metabolism/Tehran University of Medical Scie
Full name of responsible person
Ramin Heshmat
Street address
Ramin Heshmat
City
Tehran
Grant name
Grant code / Reference number
669
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Diabetes Research Center/Institute of Endocrinology and Metabolism/Tehran University of Medical Scie