Diabetic peripheral neuropathy (DPN) is one of the most common causes of morbidity and mortality in patients with diabetes and in many patients with diabetic neuropathy, pain extends as a symptom. Whole body vibration is non-invasive and has no known side effects, it is therefore important for the vibration therapy as an alternative medicine approach is clear.
This research aimed to determined effect of lower extremity vibration therapy on Diabetic neuropathic pain and with relief pain of these patients, quality of life and ability to participate in daily activities, improved.
This study was A clinical trial of a group before and after and in this study at first visit lower extremity neuropathy in 36 diabetic patients was meseared by clinical examination and assessment system and then His neuropathic pain was measured with VAS tool by helping the researcher.
In the next stage of demographic form completed by the patient and vibration therapy in patients with neuropathy is part of the body, and each time, 2 times a day for 10 minutes (for 2 weeks) was performed. Therapy vibrator made in Japan by mechanical vibration frequency was 20 Hz and finally after two weeks of intervention Pain was measured with VAS tool.
Inclusion criteria:diagnosis of diabetic neuropathy in the lower extremities,no history of any of Vibration Therapy,no history of neurological diseases such as stroke.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062310076N2
Registration date:2012-09-16, 1391/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-16, 1391/06/26
Registrant information
Name
Maryam Saeedi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3524
Email address
m.saeedi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak,Sardasht,Arak University of Medical Sciences, Research vice-chancellor
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lower limb vibration therapy on neuropathic pain in diabetic patients
Public title
The effect of vibration therapy on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of diabetic neuropathy in the lower extremities, according to a rating system based on clinical symptoms and examination (by a physician, neurologist); no history of any of Vibration Therapy; no receive pain medication or drugs affecting Vibration Therapy; lack of neurological diseases such as stroke, as well as any conditions that may impact on neuropathy (multiple sclerosis, gout, Parkinson's, spinal cord injury, Barre, rheumatic disease), and this is confirmed by a doctor, a neurologist; proven having mental illness (with doctor's approval citing cases) and minimum score of 1 neuropathic pain according to VAS scale.
Exclusion criterion: patients who are unable to work due to the project intervention.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences Ethics Committee
Street address
Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2011-10-23, 1390/08/01
Ethics committee reference number
8-115-90
Health conditions studied
1
Description of health condition studied
diabetic neuropathy
ICD-10 code
E14
ICD-10 code description
With neurological complication
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, one week after intervention, 2week after intervention and 3 days after the end of intervention.
Method of measurement
Visual analogous scale scale
Secondary outcomes
empty
Intervention groups
1
Description
vibrattion therapy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice Chancellor for Research
Full name of responsible person
Dr Davood Hekmatpou
Street address
Vice Chancellor for Research,Arak University of Medical Sciences, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences,Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rezvan Ghafarzadegan
Position
MSc nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1367 1144
Fax
Email
rghafarzadegan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rezvan Ghafarzadegan
Position
MSc nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1367 1144
Fax
Email
rghafarzadegan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
arak medical university
Full name of responsible person
Rezvan Ghafarzadegan
Position
m.s nursing
Other areas of specialty/work
Street address
arak.arak medical university
City
arak
Postal code
8859
Phone
+98 86 1367 1144
Fax
+98 36 71144
Email
rghafarzadegan@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)