Osteoarthritis is the most common disease of synovial joints and is a leading cause of disability in the elderly. In recent decades, many studies have been conducted on the treatment of non-pharmacological and physical therapy. Patients who live far away to attend the clinic regularly due to factors such as time and cost of transportation are an issue. We intended to compare the efficacy of telerehabilitation with office physiotherapy in terms of relief of symptoms and improvement of function in patients with knee osteoarthritis.
Methods: In this randomized controlled study patients with osteoarthritis of the knee were enrolled. Those with radiological criteria of severe or grade 4 osteoarthritis were excluded. The patients were randomly assigned to two groups of telerehabilitation and office physiotherapy. In the first group, exercises were instructed to patients and they were told to continue this program for 6 weeks at home. During this period doctors supervised once a week by phone. In the second group, patients attended to physical therapy clinics 3 times a week for 6 weeks and were treated with passive physical therapy modalities.At baseline before the interventions, at 6 weeks, 1 and 6 months post rehab program KOOS and WOMAC questionnaires were completed by patients and the pain was evaluated according to VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013032251N2
Registration date:2017-06-01, 1396/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Kamran Azma
Name of organization / entity
Aja University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4489
Email address
k.azma@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Artesh University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tele rehabilitation compared with rehabilitation at the clinic in patients with osteoarthritis of the knee
Public title
Knee osteoarthritis rehabilitation
Purpose
Treatment
Inclusion/Exclusion criteria
knee pain in the most of the days in the previous month, crepitation in active movements of the joints, morning stiffness less than 30 minutes, age between 45 to 60 years of old, swelling at the examination
exclusion criteria: severe osteoarthritis according to Kellgren and Lawrence radiologic criteria
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Aja university of medical sciences
Street address
Aja university of medical sciences, Shahid Etemadzadeh avenue, west Fatemi street
City
Tehran
Postal code
Approval date
2017-02-16, 1395/11/28
Ethics committee reference number
IR.AJAUMS.REC.1395.28
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17.9
ICD-10 code description
Gonarthrosis, unspecified
Primary outcomes
1
Description
pain severity
Timepoint
at the lunch of study, at the end of 6th weak, at the end of first month and at the end of 6th month
Method of measurement
Visual analogue scale, Knee injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires
Secondary outcomes
1
Description
daily activity difficulty
Timepoint
at the lunch of study, at the end of 6th weak, at the end of first month and at the end of 6th month
Method of measurement
Knee injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires
2
Description
difficulty in exersice
Timepoint
at the lunch of study, at the end of 6th weak, at the end of first month and at the end of 6th month
Method of measurement
Knee injury and Osteoarthritis Outcome Score (KOOS)
3
Description
Quality of life
Timepoint
at the lunch of study, at the end of 6th weak, at the end of first month and at the end of 6th month
Method of measurement
Knee injury and Osteoarthritis Outcome Score (KOOS)
Intervention groups
1
Description
Strengthening exercises, Flexibility exercises, Endurance exercises and active range of motion will be trained to the first group. In addition a pamphlet which illustrates exercise movements will be given to each patient.
patients should do these exercises 3 times a week for 6 weeks. Also before exercise they should put a bag of warm water on their knees for about 20 minutes.
The doctor will monitor patients over the phone once a week.
Category
Rehabilitation
2
Description
The second group should attend in the rehabilitation clinic 3 times a week for 6 weeks. They will receive passive modalities including hot pack for 20 minutes, Trans-cutaneous Electrical Nerve Stimulation (TENS) with 50 Hz frequency for 20 minutes and Ultra-Sonography with 1 MHz frequency and the intensity of 1 watt per square centimeter for 20 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Aja university of medical science
Full name of responsible person
Kamran Azma
Street address
Emam reza hospital,Etemadzadeh Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aja university of medical science
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
Aja university of medical science
Full name of responsible person
Sara sadat Mohsenalhosseini
Position
Doctorate
Other areas of specialty/work
Street address
First floor,39 No,Shams Alley,Vesal shirazi street
City
Tehran
Postal code
Phone
+98 21 6641 4596
Fax
Email
saramah22@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Aja university of medical science
Full name of responsible person
Sara Sadat Mohsenalhosseini
Position
Doctorate
Other areas of specialty/work
Street address
First floor ,No 39, Shams Alley ,Vesal shirazi Street
City
Tehran
Postal code
Phone
+98 21 6641 4596
Fax
Email
saramah22@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)