(1) Objectives: Our aim in this study is to evaluate the efficacy of Action Potential Simulation and Interferential therapy in the rehabilitation of patients with knee osteoarthritis. (2) Design: 70 patients with knee osteoarthritis will enter the trial process after qualifying the inclusion and exclusion criteria. (3) Setting and conduct: Patients will be randomly assigned to two groups. First group will receive Action Potential Simulation (APS) in their physiotherapy protocol and second group will receive interferential therapy for ten sessions. All patients in physiotherapy sessions will receive the usual physical modalities equally. Evaluation of the patients will be done before tudy and two months later. (4) Participants including major eligibility criteria: Participants will be selected among the patients with mild to moderate knee osteoarthritis. The key exclusion criteria are age under 50 years old, Rheumatologic disease, History of knee surgery, Severe knee osteoarthritis, Electrical implants like pacemaker, Heart conduction block disease, Epilepsy, Cancers, lower limbs thrombosis,Balance control deficit, Neuropathy or sensory deficit, Skin breakdown in knee region and intraarticular corticosteroids within 6 month. (5) Interventions: Using Action Potential Simulation or Interferential therapy. (6) Main outcome measures: WOMAC and visual analogue scale measurement will be used before and at the end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403024641N8
Registration date:2014-03-06, 1392/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-06, 1392/12/15
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Action Potential Simulation and Interferential therapy in the rehabilitation of patients with knee osteoarthritis
Public title
Efficacy of different physiotherapy methods in the rehabilitation of patients with 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 to 100 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
Ethics Committee of Tabriz University of Medical Sceinces
Street address
Research ministry, Second central building, Tabriz University of Medical Sciences, Golgasht street Tabriz
City
Tabriz
Postal code
Approval date
2011-11-28, 1390/09/07
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 intervention and two months later
Method of measurement
Visaul Analogue Scale
Secondary outcomes
1
Description
Function Improvement
Timepoint
Before intervention and two months later
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Intervention groups
1
Description
First group will undergo Action potential stimulation (APS) 10-15 minutes each session for 10 session.ll patients (both groups) in physiotherapy sessions will receive the usual physical modalities equally.
Category
Rehabilitation
2
Description
Second group will undergo inferential therapy (IFT) 10-15 minutes each session for 10 sessions.ll patients (both groups) in physiotherapy sessions will receive the usual physical modalities equally.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Dr. Bina Eftekharsadat
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical medicine and rehabilitation researches center
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical medicine and rehabilitation researches center
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. Bina Eftekharsadat
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 1928
Fax
Email
binasadat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 1928
Fax
Email
binasadat@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. Bina Eftekharsadat
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)