Design, construct and evaluate vibrating silicon liner on the phantom pain in traumatic below knee amputees
Design
Clinical trial, single group, no control group, not blinded
Settings and conduct
Study on the Red Crescent of Tehran, vibrating silicon liners are built for all people according to their stump structure, each participant using vibrating silicone liner three times per day for 10 minutes and in a period of 30 days, the severity of pain was evaluated by the short form of McGill Pain Questionnaire before and after thirty days using vibrating silicon liner.
Participants/Inclusion and exclusion criteria
Traumatic below knee amputation with phantom pain
Intervention groups
Vibrating Silicon Liner
Main outcome variables
Phantom pain measuring
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140219016643N5
Registration date:2019-01-26, 1397/11/06
Registration timing:retrospective
Last update:2019-01-26, 1397/11/06
Update count:0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Behshid Farahmand
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
farahmand.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-27, 1395/03/07
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
2016-05-27, 1395/03/07
Actual recruitment end date
2017-01-29, 1395/11/10
Trial completion date
2018-08-01, 1397/05/10
Scientific title
The effect of vibrating silicone liner on phantom pain in below knee amputees
Public title
The effect of vibration on the phantom pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic below knee amputee
Phantom pain score 4 or more based on the Visual Analog Scale
Exclusion criteria:
Bilateral amputation
Stump length more than 7 inches
Did not use prosthesis
Received other medical or non-surgical treatments for phantom pain
Suffered from other diseases such as diabetes, joint rheumatoid arthritis, and neuromuscular problems
Before intervention, immediate after intervention, after 30 days use of vibrating silicone liner
Method of measurement
Short form of McGill Pain Questionnaire
Secondary outcomes
1
Description
Relationship between level of pain and demographic variables such as age, body mass index, Duration of amputation and the level of initial pain
Timepoint
Before intervention, after 30 days use of vibrating silicone liner
Method of measurement
Visual Analog Scale, demographic questionnaire
Intervention groups
1
Description
Vibrating silicon liner: the silicone liner is made of two layers and has an elasticity effect due to the use of socks between layers. The connecting wires of the vibration motors are placed between the two layers of the liner. Vibration motors are placed at the pain location, close to the nerve and peroneal artery and at the end of the stump to stimulate the neural mechanisms and proprioception. The ends of the vibration connections are connected to a socket, where the adapter is installed as a power supply. The power supply consists of an adapter with a maximum voltage of 12V and, due to the low voltage, does not pose any danger to the patient. Vibration is also applied at a frequency of 100 Hz by vibration motors.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Red Crescent Rehabilitation Center
Full name of responsible person
Omid Turkeman
Street address
Valiasr Street, after Mirdamad, Rashid Yasemi Street
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 8820 1241
Email
omid.turkeman@yahoo.com
Web page address
http://tavanbakhshi.rcs.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Malakoti
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics & Prosthetics
Street address
Mather squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Fax
+98 21 2222 0946
Email
farahmand.b@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics & Prosthetics
Street address
Mather Squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Fax
+98 21 2222 0946
Email
farahmand.b@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics & Prosthetics
Street address
Mather Squre, Abkar Shahnazari Street, Madadkaran Street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Fax
+98 21 2222 0946
Email
farahmand.b@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All study data are shareable after deleting the profile and contact number of the participants
When the data will become available and for how long
The start access is determined according to the law of the journal which the article is submitted
To whom data/document is available
Accessibility for all people
Under which criteria data/document could be used
Do not consider a particular item
From where data/document is obtainable
Contact by e-mail of corresponding author
What processes are involved for a request to access data/document
If there is no precautionary statement from the journal which the article is printed, with contact by e-mail of corresponding author, information will be sent to the requesting person within less than one month