Efficiency of Action Potential Simulation (APS) therapy in compare to Transcutaneous Electrical Nerve Stimulation (TENS) in rehabilitation of knee osteoarthritis
The aim of this study is determination of the best physical modality for pain relief in rehabilitation of knee osteoarthritis. Design of study is randomized and double blinded. The main inclusion criteria is mild or moderate knee osteoarthritis and the main exclusion criteria includes age under 50 years, patients suffering from rheumatologic disease, history of knee surgery and severe knee osteoarthritis. In this study 70 knee osteoarthritis patients will assign randomly to two groups, each group with 35 cases. Firs group will receive Action Potential Simulation (APS) in their physiotherapy protocol and second group will receive Transcutaneous Electrical Nerve Stimulation (TENS). The study will be conducted between 2012-01-01 and 2012-03-20. Main outcome is pain relief, which will be studied by the questionnaire VAS (Visual Analog Scale). The intervention includes 10 physiotherapy sessions. All patients (both groups) in physiotherapy sessions will receive the usual physical modalities equally. The only physical modality which is different in two groups is electrotherapy, one group will receive Action Potential Simulation (APS) and second group will receive Transcutaneous Electrical Nerve Stimulation (TENS). Time period for receiving electrotherapy in each session is 10 to 15 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112171292N2
Registration date:2012-01-06, 1390/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-06, 1390/10/16
Registrant information
Name
Vahideh Toopchizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 984113335625
Email address
toopchi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of Action Potential Simulation (APS) therapy in compare to Transcutaneous Electrical Nerve Stimulation (TENS) in rehabilitation of knee osteoarthritis
Public title
Effectiveness of different physiotherapy protocols in rehabilitation of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mild or moderate knee osteoarthritis based on American College of Rheumatology criteria
Exclusion criteria: Age under 50 years old; Rheumatologic disease; History of knee surgery; Lower limbs fracture with knee joint involvement; Severe knee osteoarthritis; Electrical implants like pacemaker; Heart conduction block disease; Epilepsy; Cancers; Pregnancy; Lower limbs thrombosis; Couldn't complete questioners for any reason; knee joint injection in previous 6 month; Balance control deficit; Neuropathy or sensory deficit; Skin breakdown in knee region
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Research ministry, Second central building, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
9055
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Polyarthrosis, unspecified
Primary outcomes
1
Description
Pain relief
Timepoint
Before and after physioterapy
Method of measurement
Questioner
Secondary outcomes
1
Description
Improve performance
Timepoint
Before and after physioterapy
Method of measurement
Questioner
Intervention groups
1
Description
The intervention includes 10 physiotherapy sessions. All patients (both groups) in physiotherapy sessions will receive the usual physical modalities equally. The only physical modality which is different in two groups is electrotherapy, this group will receive Action Potential Simulation (APS). Time period for receiving electrotherapy in each session is 10 to 15 minutes.
Category
Rehabilitation
2
Description
The intervention includes 10 physiotherapy sessions. All patients (both groups) in physiotherapy sessions will receive the usual physical modalities equally. The only physical modality which is different in two groups is electrotherapy, this group will receive Transcutaneous Electrical Nerve Stimulation (TENS). Time period for receiving electrotherapy in each session is 10 to 15 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Dr Vahideh Toopchizadeh
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tabriz University of Medical Sciences
Street address
Research ministry, second central building, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahideh Toopchizadeh
Position
Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Research ministry, second central building, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
toopchi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahideh Toopchizadeh
Position
Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Research ministry, second central building, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
toopchi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahideh Toopchizadeh
Position
Other areas of specialty/work
Street address
Research ministry, second central building, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)